International Conference on Clinical Trials July 27-29, 2015 Orlando-FL, USA

Biography:

Laurie Littlepage, Ph.D., is the Campbell Family Assistant Professor of Cancer Research at the University of Notre Dame in the Department of Chemistry and Biochemistry and in the Harper Cancer Research Institute. She also is an Associate Member of the Indiana University Melvin and Bren Simon Cancer Center, Breast Cancer Research Program. She received a Ph.D. in Cell and Developmental Biology from Harvard University and postdoctoral training at the University of California, San Francisco. She received a B.S. in Biochemistry and a B.S. in Molecular Biology from the University of Texas at Austin.

Abstract:

Understanding the molecular mechanisms of therapeutic resistance is critical to identify novel therapeutics that overcomes metastasis, resistance, and death. We previously identified the transcription factor ZNF217 as a prognostic indicator for breast cancer patients. ZNF217 is overexpressed in breast and other cancers, and this overexpression promotes reduced survival, increased metastasis, and reduced response to therapy in patients and in our animal models. We determined if Znf217 overexpression contributed to chemotherapy resistance. We treated mice overexpressing Znf217 or vector with a combination therapy of microtubule inhibitor epothilone B, adriamycin, and cyclophosphamide (EAC). The mice overexpressing Znf217 had increased tumor volume and decreased percent survival compared to control mice. Mice overexpressing Znf217+ EAC had increased tumor volume over controls, suggesting that mice overexpressing Znf217 developed resistance to the EAC chemotherapy. To overcome breast cancer chemoresistance caused by ZNF217 overexpression, we identified triciribine, a nucleoside analog and AKT inhibitor, as a drug that kills cells that overexpress ZNF217. We have used our preclinical animal models of Znf217 overexpression to elucidate the appropriate dosing for combination therapy of triciribine and the microtubule inhibitor paclitaxel to treat breast cancer. We found that the treatment order impacts the therapeutic efficacy. This study will directly influence the design of Phase II clinical trials with triciribine and paclitaxel in metastatic breast cancer patients.

Biography:

James J. Hickman is the Founding Director of the NanoScience Technology Center and a Professor of Nanoscience Technology, Chemistry, Biomolecular Science, Physics, Material Science and Electrical Engineering at the University of Central Florida. Previously, he held the position of the Hunter Endowed Chair in the Bioengineering Department at Clemson University. Dr. Hickman has a Ph.D. from the Massachusetts Institute of Technology in Chemistry, as well as BS and MS from Penn State University in Chemistry. For the past twenty-five years, he has been studying the interaction of biological species with modified surfaces, first in industry and in the latter years in academia. While in industry he established one of the first bioelectronics labs in the country that focused on cell-based sensors and their integration with electronic devices. He has extensive experience in surface modification and surface analysis for biological and neuroscience applications, and the integration of these systems with MEMS devices and components for human body-on-a-chip applications. He is also the founder and current Chief Scientist of a biotechnology company, Hesperos, that is focusing on cell-based systems for drug discovery and toxicity. He has 110 publications and 18 book chapters, in addition to 26 patents.

Abstract:

One of the primary limitations in drug discovery and toxicology research is the lack of good model systems between the single cell level and animal or human systems. This is especially true for neurodegenerative diseases as well as for cardiac disease and cardiac side effect determination during the drug discovery process. In addition, with the banning of animals for toxicology testing in many industries, body-on-a-chip systems to replace animals with human mimics is essential for product development and safety testing. There is also a push to utilize in vitro systems to establish biomarkers to select subsets of the population for clinical trials and even to augment human testing during clinical trials. Our research focus is on the establishment of functional in vitro systems to address this need where we seek to create organs and subsystems to model motor control and cognitive function, as well as cardiac and liver subsystems. The idea is to then integrate microsystems fabrication technology and cellular components, with the aim of initiating and maintaining self-assembly and growth into biologically, mechanically and electronically interactive functional multi-component systems. Our advances in culturing human stem cell derived neurons, glial cells, muscle, liver and cardiomyocytes in a defined serum-free medium, and integreat them with MEMS devices suggest outstanding potential for answering questions during all phases of the drug discovery process using functional body-on-a-chip systems.

Biography:

Jingjing Yin received her Bachelor degree in Public Health Administration from Sichuan University in China. She obtained PhD in Biostatistics at University at Buffalo. Simultaneously, she was a Teaching Assistant for one Undergraduate Course and two Graduate Courses and then she became a Research Assistant working as a Biostatistician at Buffalo VA Medical Center and Statistical Consulting Laboratory at University at Buffalo. Immediately after completion of her PhD degree, she joined the Department of Biostatistics at Georgia Southern University. She has 10 publications and serves as the Associate Editor of Biometrics & Biostatistics International Journal.

Abstract:

In medical diagnostics, the ROC curve is the graph of sensitivity against 1-specificity as the diagnostic threshold runs through all possible values. The ROC curve and its associated summary indices are very useful for the purpose of evaluating the discriminatory ability of biomarkers/diagnostic tests with continuous measurements. Among all summary indices, the area under the ROC curve (AUC) is the most popular diagnostic accuracy index and it has been extensively used by many researchers for biomarker evaluation and selection. Sometimes, taking the actual measurements of a biomarker is very difficult and expensive while ranking them without actual measurements can be easy. In such cases, ranked set sampling which based on order statistics would give more accurate estimation than simple random sampling, since ranked set samples are more likely to span the full range of population (thus is more representative). In this study, Gaussian kernel is utilized to obtain a nonparametric estimate of AUC. Intensive simulations are carried out to compare the proposed method using ranked set samples with the one using simple random samples and the proposed method out performs universally with much smaller mean squared errors (MSE). A real data set is analyzed for illustrating the proposed method.

Biography:

James Stamey, PhD, is professor and graduate program director for the Department of Statistical Science at Baylor University. His research is primarily on Bayesian methods for measurement error and misclassification along with applications in pharmaceutical statistics and health economics.

Abstract:

We consider the case of comparing two or more proportions to a control in the case where interest is in an event such as an adverse event where the probability of occurrence is low. Also, we allow for potential misclassification in the assay. We investigate several different properties of a Bayesian inference procedure via simulation. The properties investigated include the following. We determine the bias and interval coverage for various non-informative priors to determine which prior is best. We also investigate the impact of misclassification on the bias and power. Finally, we overview a simulation based sample size determination procedure.

Biography:

Misako Nakashima has completed her PhD at the age of 25 years from Kyushu University and Postdoctoral Studies at National Institute of Dental Research, NIH, and Johns Hopkins University and New York University. She has published more than 80 papers in reputed journals

Abstract:

The dentin-pulp complex does not regenerate spontaneously in pulpectomized adult tooth with complete apical closure as observed in root canal filling. Our preclinical work has demonstrated therapeutic potential of dental pulp stem cell (DPSC) subsets isolated by granulocyte-colony stimulating factor (G-CSF)-induced mobilization, known as mobilized DPSCs (MDPSCs) for complete pulp regeneration. We further assessed the safety and feasibility of autologous transplantation of human MDPSCs in pulpectomized tooth and evaluated cell therapy in a clinical trial. The trial was approved and monitored by the Japanese Ministry of Health, Labour and Welfare and by the Ethics Committes. Clinical-grade MDPSCs were isolated and expanded according to GMP conditions. The MDPSCs with granulocyte-colony stimulating factor (G-CSF) suspended in atelocollagen were transplanted into pulpectomized tooth. A total of 5 patients with irreversible pulpitis were enrolled and regularly monitored before and after transplantation for 24 weeks. Excellent quality control of the final individual product, MDPSCs was assured after freezing and thawing by the lack of contamination, abnormalities/aberrations in karyotype and the expression of stem cell markers, CD29, CD44, and CD105 and absence of CD31. The clinical laboratory and radiographic evaluations demonstrated no transplant-related evidence of toxicity and adverse events. Pulp vitality by electronic pulp testing turned a positive response within 4 weeks after transplantation (n=4). Magnetic resonance imaging (MRI) demonstrated the similar signal intensity in the root canal at week 24 to that in normal pulp. These results suggest that MDPSCs transplantation into the pulpectomized tooth is safe andefficacious for pulp regeneration in humans.

Biography:

Dr. Sanjay Kumar was completed his PhD from Jawaharlal Nehru University, New Delhi and postdoctoral research training at Indiana University, Indianapolis and University of Tennessee Health Science Centre, Memphis, USA, 2008-2012. Currently, Dr. Kumar is working as postdoctoral research associate at Jackson state University and his research focused on investigation of new target of Trisenox action in acute promyelocytic leukemia (APL) cells by modulation of cell cycle, p53 , signaling and apoptosis using mice model of APL. He has published 16 international research papers and also serving as member of editorial board and reviewer of five reported journals.

Abstract:

Trisenox (TX) alone or combination with all trans retinoic acid (ATRA) has been successfully used in the treatment of acute promyelocytic leukemia (APL) patients with highest survival rate. Clinical trials study of TX and their combination with ATRA was shown complete remission in both de novo and relapsed APL patients. However, the exact molecular mechanisms of its action through cell cycle arrest and apoptosis are poorly understood. We hypothesized that TX modulates cell cycle and apoptosis through activation of p53 and interaction of death domain-associated protein (DAXX), which disrupted the MDM2-DAXX-HAUSP interaction, MDM2 degradation and their self –ubiquitination. To test the hypothesis, we used western blotting, confocal imaging and other molecular techniques to identify new target of TX action in APL cells. We found that the expression levels of p53 and p21 increased significantly, whereas MDM2, DAXX and HAUSP decreased in a dose dependent. Our immunoprecipitation (IP) studies shown that they are well associated each other in cells and TX disrupted their association. After 21 days treatment of TX different doses (1.25, 2.5, 5.0 and 7.5 mg/kg body wt) in transgenic mice, we isolated liver tissue and bone marrow cells. We found, p53 was activated in a dose dependent TX treated mice. We conclude that TX disrupts MDM2-DAXX-HAUSP complex, release and degradation of MDM2 expression in APL cells. It leads to accumulation of p53, cell cycle arrest and apoptosis in APL cells. It is novel target for treatment of APL patients by TX and also designing of new drugs.

Biography:

Rucha Majmundar Mehta is an Independent GCP auditor (Free Lancer) since 8 years. She developed a Clinical Research Site in a privately owned small sized hospital and heading the site till date. She is providing QA consultation and training to various study sites and QA department of Pharmaceutical Companies. She conducts GCP Sessions during Investigators Meetings globally. She has participated in State, National and International Conferences of Clinical Research as a faculty. She is conducting GCP workshops for Clinical Research Professionals for on-going basis and during conferences. She is active member of EFGCP–AWP and RQA

Abstract:

Fraud and misconduct in the research community occur more often than we would wish to believe. While it is impossible to provide a definitive figure for the frequency of its occurrence surveys provide us with consistently (and perhaps surprisingly) high estimates. Fraudulent clinical research affects the validity of data and impacts on the dignity, rights, well-being and safety of research participants. There are a variety of definitions of fraud and scientific misconduct. Often, the terms ‘fraud’ and ‘misconduct’ are used interchangeably. Generally, fraud describes acts of omission and commission, consciously not revealing all data and consciously altering or fabricating data. Such falsification of data can occur at any stage of the research process, from initial design through to reporting results. Fraud does not include honest errors or differences in opinion and the usual definitions include an element of intent. Repeated non-compliance with the study protocol and GCP may be considered as an example of misconduct, although the end result may well be similar to deliberate fraud. There are examples, from the beginning of a clinical trial to submission of a final manuscript, of dishonesty and deceit in general practice and primary care research. Patients have been invented to increase numbers (and profits) in clinical trials, ethical guidance on consent and confidentiality have been breached, and duplicate publication crop up from time to time. It is important for us all to be aware of the legal and ethical frameworks within which research is undertaken and of the steps that are available to prevent fraudulent and dishonest research being undertaken and written up.

Biography:

Helen Snooks is the Professor of Health Services Research in the Swansea University Medical School, UK. She is the Interim Director of the Swansea Trials Unit (STU) and leads the Patient and Population Health and Informatics (PPHI) research stream at Swansea University. Helen’s main research interests and expertise lie in the fields of Emergency Pre-hospital and Unscheduled Care, Clinical Audit and Effectiveness, and research support. The focus of her work is to plan, design and carry out evaluations of health technologies and new models of service delivery. Helen has a Bsc (Hons) Economics, Sociology, Statistics from University of Surrey with a PhD in Health Services Research ‘Post Traumatic Stress Disorder in seriously injured accident victims’ at the University of Sheffield in 2000.

Abstract:

Background: For patients to fully contribute their expertise to designing and conducting collaborative research, the interaction process with academic and organisational experts needs to be effective. Objectives: To describe development and implementation of a model to enhance patient involvement in health and social care research. Methods: Patients with chronic conditions were supported by a researcher to develop ways to enable their involvement in research about chronic conditions management. We explored experience of being involved in research through the model through interviews with participating patients, academics and senior managers responsible for health policy and services. Data were audio-recorded with consent and analysed using Interpretative Phenomenological Analysis. Results: Patients established a pool structure, sharing support, information and skills development while available for recruitment to more than 30 collaborative research opportunities over three years. Interview respondents agreed the model increased the number and proficiency of patients involved in research. Academics and organisational managers perceived this was a credible and legitimate patient group. But recruitment and communication processes were confusing and interaction in research meetings was not consistently effective, they reported. Patients found the language and culture of research environments was off-putting and said they did not always know what they should and could contribute. Conclusions: We developed a model which enhanced patients’ contributory expertise and strengthened some interaction processes when they were involved in research through collaboration. Further research training for patients, improved communication and better ways to match patients’ skills to research opportunities are needed to strengthen the model. Research teams should also clarify aims and roles of all collaborators when involving patients in research, to enable all expertise to be effectively integrated within research processes.

Biography:

Galya Atanasova completed her Ph.D. training in Cardiology from Department of Cardiology, Pulmonology and Endocrinology at Pleven Medical University, Bulgaria. She is a General Practitioner and Cardiologist in Trainee at Pleven Medical University, Bulgaria. She specialized in General Medicine from Pleven Medical University, Bulgaria during 1993. She has attended to many international events and presented her research work. She did many researches on metabolic syndrome and myocardial infarction of heart.

Abstract:

In a number of epidemiological studies, elevated blood pressure (BP) has been identified as a risk factor for coronary artery disease, heart failure, cerebrovascular disease, etc. The object of the study is to assess the degree of influence BP as a risk factor for myocardial infarction (MI) by logistic regression analysis. During year 2012 study in 99 subjects with survived MI, inhabitants of Pleven region in republic of Bulgaria was conducted. The following biomarkers are tested (fasting): HDL-cholesterol, serum triglycerides (TG) and total cholesterol (TC). Data processing is a logistic regression analysis. In our study developed two regression models. The first model includes SBP, level of triglycerides (Tg) and the level of total cholesterol (TC). An increase of 10% from the average value of the factor increase in OR for the occurrence of MI in men SBP is 2.05 times, and the level of TC was 1.28 times). The second model includes SBP, Tg levels and levels of HDL-cholesterol. Increase by 10% the level of Tg in little increase in the chances of occurrence of MI in women (1.05 times) and can therefore be concluded that Tg is not a risk factor for subjects studied.The most important risk factor for MI in our study is the increase of SBP. It has a great influence on the attitude of the chances of heart attack in men than in women.

Biography:

Ajay Francis Christopher, MSc (Molecular Biology & Biochemistry from Guru Nanak Dev University, India) served as PV Scientist, Senior Quality Scientist and Subject Matter Expert-PVQA for blue-chip pharmaceutical companies at a premier CRO in India. He has one Young Scientist Award and various appreciation awards to his credit. He successfully led various international projects (global transition in narrative writing for regulatory submission, customization and validation of Oracle Argus Safety 5.0.2, etc). He has published and presented research articles on microRNA expression in medulloblastoma and gliomas, plasmid profiling, unique mutations in beta-thalassemia and presently working on miRNAs targets of herbal extract with potentials of anti-cancer drug.

Abstract:

The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, evaluation, understanding, and prevention of adverse reactions to medicines or any other medicine-related problems. In 1893, The Lancet first reported an established drug safety reporting system for suspected adverse drug reactions (ADRs). Since then, the definition and scope of pharmacovigilance have evolved as a systems approach. Pharmacovigilance is a highly sensitive field as it involves monitoring of the safety of medicines and taking action to reduce risk and increase benefit. The pharmacovigilance data management starts with the data collection and, it is imperative to address the report origin, triage cases, enter information in drug safety database, make medical assessment, request report follow-up information and mode for regulatory submissions. All these stages require a high and complex degree of technical skill and judgment to ensure that accurate conclusions and right decisions are made during the establishment of benefit-risk profile for a product. A poor pharmacovigilance data management not only jeopardizes patient safety, it also increases the risk of investing in the development of wrong product which causes a huge loss to a pharmaceutical company. Therefore, it is very important to establish a robust pharmacovigilance data management system which complies with the stringent regulatory guidelines, global pharmaceutical norms and ultimately safeguard the pharmacovigilance end users, the patient. An ideal model would be implementation of business management software (e.g. Microsoft Dynamics NAV/SAP ERP) for better data management, process harmonization, enhanced data security and reduction in delay due to high manual dependence.

Biography:

Paula M Frew is an Assistant Professor of Medicine (Infectious Diseases) and Public Health (Behavioral Sciences and Health Education) at the Emory University School of Medicine and at the Emory Rollins School of Public Health. She is also a Health Scientist at the Centers for Disease Control and Prevention (National Center for Immunization and Respiratory Diseases). She has published more than 60 papers in peer-reviewed journals and is a highly respected expert in community engagement with clinical research, lectures on health disparities in clinical research and she is the recipient of several national awards in clinical research, community engagement and public health.

Abstract:

Under representation of older African Americans is a serious problem in clinical research. We evaluated how a faith-based educational intervention influenced clinical trial participation among 221 subjects aged 50 to 95 years recruited from six Atlanta Black churches. Nearly half (n=112) were assigned to the intervention, comprising three educational discussion sessions about clinical trials; comparison participants (n=109) completed surveys. Both groups received ongoing notifications about clinical trials seeking participants. Using mixed methods research approaches; we explored participants intentions to seek clinical trials information and tracked their subsequent clinical trial enrollment. Qualitative interviews revealed participants’ interest in learning about clinical studies and their enthusiasm for the program. Yet, multivariable linear mixed models showed that participation was not significantly associated with overall increased levels of two intention measurements. Among intervention group participants however, intention to seek information about trials increased significantly by 3 months (mean difference=1.98, p<0.05) and at 6 months (mean difference=1.49, p<0.05). Younger age was associated with increased intention to seek information at 3 months (p<0.01) and 6 months (p<0.01) and with increased intention to join trials at 3 months (p<0.001) and 6 months (p<0.05). Qualitative data revealed participants’ enthusiasm about the intervention program including its accessibility and health disparities focus. Intervention participants' reported increased intentions to seek information about and join clinical trials, though this increase was not significantly associated with the intervention itself. Overall, we found those who were younger (example ≤70 years) expressed greater interest in trial participation and experienced greater treatment effect on intention to join trials.

Biography:

Anvita Karara is a Life Science Professional with expertise in Clinical Trial Design and modeling. She pursued her Masters in Biotechnology and Management from Carnegie Mellon University, USA. She has worked prior in this space with leading bio-pharmaceutical companies such as Genentech (a Roche company) and Onyx Pharmaceutical (an Amgen subsidiary).

Abstract:

Having a clinical study design which optimizes patient enrollment, site selection and clinical trial budget is one of the biggest challenges for bio-pharmaceutical R&D industry. Since the first trials of legumes in biblical times to the first randomized controlled trial of Streptomycin in 1946, clinical study designs are always aimed to answer a specific scientific question. The increasing clinical trial cost and cycle time in the life science sector has indicated that just answering a specific scientific question is not enough. It is necessary for the clinical study design to focus on potential downstream trial execution activities, patient enrollment and to prevent costly protocol amendments. In order to address these issues we need to combine the clinical study designs process with technology and leverage data. The clinical design software solutions integrate real world patient, cost and investigator data to perform clinical modelling and simulations. The real world modelling produces “what-if scenarios” which helps in analyzing cycle time, cost and risk tradeoff in present and future. Based on the clinical performance data and their internal algorithms, these tools can perform “tiering” of country and investigator sites in alternatives such as best, average and least optimum. They also ensure precise linkages occur between objectives, endpoints and procedures in the protocol. Predictive analytics and real world modelling design tools would help the clinical development teams to take data driven informed decisions. These tools will optimize patient enrollment and site selection, prototype multiple scenarios, reduce protocol amendments and help mitigate risk in study development.

Biography:

Iman GhodratiToostani has completed his master in neuroscience and cognition from Federal university of ABC and Currently he is PhD student in University of Sao Paulo. He is the director of Multidisciplinary Tinnitus rehabilitation Project as a Multicenter clinical study which recently granted by Sao Paulo research foundation and “Center for Mathematical Sciences Applied to Industry”, he is Member of Multidsciplinary Neuro-cognitive Laboratory as well. He has projected Neurofucntional tinnitus model since 2012, based on that he is developing several software in Tinnitus evaluation and Tinnitus rehabiliatation, and recently concentrated on decision support system development in Tinnitus field.

Abstract:

As an opened question how we can apply evidence-based TES research clinical trial protocol in routine clinical procedures? In order to be able to recommend any novel evidence-based TES protocol for clinical healthcare system, it is required to define a gold standard by means of independent specialist panel which we call them gold standard provider (GSP).Projecting clinical recommendations occurs through an ecosystem in which often many stockholders competing interests to have their own preferences or idea about delivery of the health care services. Despite of specific regulation in healthcare systems of different countries, we intend to propose a general model analogy to define, update, reaffirm, and, inactive of TES evidence-based clinical recommendation. The range of our model covers brain science frontiers and GSP ecosystems and their nitch platforms. The GSP processes of selecting topics, synthesizing evidence, deliberating and voting on recommendation, soliciting peer review, and finalizing recommendations have evolved over time. The purpose of current model is continually suggest and improve the methods of evidence-based TES reviews, to maintain transparency and objectivity and increase GSP efficacy. Accordance to Brain science frontier (BSF) knowledge development model, achievements in cognitive sciences, neuroscience, behavioral information, neuroimaging altogether with Electrical stimulation technologies may improve neuromodulation hypothesis and questions which may lead theoretical neurofunctional model of special disease. Brain scientists investigate on proposed hypothesis through several TES research clinical trials which may result in short-term or long-term effect on desired brain regions or network by mentioning following issues such as a)localization of stimulation, b) Mechanisms of action,c) Durability and Accumulativeness of effects, d) Reliable evidence and e) Combination with routine interventions (TAU). Outstanding effects accordance to proposed model can offer to GSP as a potential new topic of clinical recommendation. GSP consider weather really nominated TES topics are within the scope of GSPs’ and prioritizes the topics by mentioning specific criteria of public health, and, GSPs’ potential effect of clinical practice. We were simulated the TES clinical protocol recommendation model in order to evaluate its performance by applying full evidence review in Tinnitus TES rehabilitation.

Biography:

She is registered nurse and she had master degree in nursing (adult care nursing). She worked as teaching assistant in the Hashemite University (Jordan) for four years and as cardiac care nurse in King Abdullah University Hospital (Jordan) for four years.

Abstract:

Background: Patients with CHD often do not follow prescribed physical activity recommendations. Aim: To assess the efficacy of behavioural intervention to increase physical activity in patients not attending supervised physical activity programmes. Design: Randomised controlled trial comparing 6-month multi-component behavioural change intervention (n=85) with usual care (n=71). Intervention included one face-to-face individualised consultation, 6 telephone support calls (for goal-setting, feedback and self-monitoring) and 18 reminder text messages. Setting: Two hospitals in Jordan, Middle East. Participants: 156 patients with CHD (mean age 57.5 years; 54% male, 46% female). Measurements: Outcomes measured at baseline and 6 months. Primary outcome was physical activity level. Secondary outcomes were blood pressure, body mass index, exercise self-efficacy for exercise and health-related quality of life. Findings: Intervention and control groups were comparable at baseline. Moderate physical activity significantly increased in intervention group compared with control group (mean change (SD) of frequency: 0.23 (0.87) days/week versus -.06 (0.40), duration: 15.53 (90.15) minutes/week versus -3.67 (22.60) minutes/week and intensity: 31.05 (105.98) Metabolic equivalents (METs) versus 14.68 (90.40) METs. Walking significantly increased in the intervention group compared with control group (the mean change (SD) of frequency: 3.15 (2.75) days/week versus 0.37 (1.83) days/week, duration: 150.90 (124.47) minutes/week versus 24.05(195.93) minutes/week and intensity: 495.12 (413.74) METs versus14.62 (265.06) METs. Intervention participants had significantly lower blood pressure, lower body mass index, greater exercise self-efficacy and better health-related quality of life at 6 months compared with controls. Conclusions: Multi-component behavioural intervention increases physical activity, and improves body composition, physiological and psychological outcomes in CHD patients not attending structured rehabilitation programs.

Biography:

Abstract:

Background: Previous studies regarding rhythm control in patients with Atrial Fibrillation (AF) could not demonstrate the enough efficacies of available anti-arrhythmic drugs. The “upstream therapy” has emerged as a potential strategy for the prevention and treatment of AF. The use of angiotensin II receptor blockers (ARBs) and statins have been suggested to decrease new-onset AF in previous studies but which have remained inadequately explored. This study was designed to examine whether valsartan and or fluvastatin can reduce the probability of non-permanent AF in patients with hypertension. Methods/Design: The VF-HT-AF study is a multicenter, randomized, open-label, four-arm parallel group study with comparative evaluation of valsartan and fluvastatin as upstream therapies for the patients with non-permanent AF complicated hypertension. The primary endpoint is the difference in the development of paroxysmal AF into persistent and or permanent AF, persistent AF into permanent AF as well as the incidence of overall and persistent AF recurrence which are evaluated by 7-days ambulatory electrocardiograph monitoring (Holter) and patients’ diaries during 2 years follow-up. The secondary endpoints of this study include: (1) Fatal and nonfatal myocardial infarction; (2) Heart failure (NYHA III or IV); (3) Cardiogenic shock; (4) Serious bleeding which need to be hospitalization; (5) Malignant ventricular arrhythmia (including ventricular tachycardia and or fibrillation); (6) Revascularization therapy (CABG/PCI); (7) Radiofrequency catheter ablation of AF; (8) The changes of left atrial dimension on ultrasound echocardiography; (9) Stroke; (10) Cardiovascular mortality; and (11) All-cause mortality. The study will follow 1879 hypertensive patients with non-permanent AF who are treated at 15 medical centers throughout China and will provide available or useful clinical information. Discussion: The proposed study, evaluating the impact of implementing valsartan and or fluvastatin treatment on non-permanent AF is the first study in hypertensive patients’ complicated non-permanent AF in Chinese population. Results of this study will contribute to the upstream therapies of AF.

Biography:

Samina Qureshi is the Medical Director of the Health Sciences Division at PSI International Inc. She is a physician and is also pursuing an Advanced degree in Regulatory Science at the prestigious Johns Hopkins University. She is also an expert in various dictionaries, including the Medical Dictionary for Regulatory Activities (MedDRA), the World Health Organization Drug Dictionary (WHO-DD) and International Classification of Disease (ICD 9/10). She has supported Clinical and Pharmacovigilance activities at a senior level with over 20 pharmaceutical clients, the World Health Organization- Uppsala Monitoring Center as well as the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Adverse Events Reporting Programs Support; National Institutes of Health (NIH) and at U.S. Army Medical Materiel Development Activity (USAMMDA) providing training to data management staff.

Abstract:

The capture of safety data in the health care/life sciences context involves the use of many diverse terminologies. The purpose of these many terminologies is varied, ranging from capturing adverse events to categorizing diagnoses and procedures. The most important use of these terminologies involves the performance of good quality coding. Employing high quality and superior standards of coding translates into choosing terms within the respective terminology that most closely and accurately captures the concept observed or captured. Whether that concept is a product name in the case of pharmaceuticals or expression of an adverse event, the principle objective remains the same: Maintaining the integrity of information. The primary purpose of developing coding terminologies is to provide a uniform, consistent and reliable methodology to express concepts without losing expression of the integrity of the event. The correct use of coding terminology allows for the capture of “good” data and the production of aggregate results that lend themselves to reliable and meaningful analysis. Such a process ensures accurate signal detection that is neither diluted nor magnified. Because there are numerous terminologies, this workshop focuses on those described in the Medical Dictionary for Regulatory Activities (“MedDRA”) which is often used to capture adverse events after drug exposure and the World Health Organization’s Drug Dictionary (“WHO-DD”) which is used to capture concomitant medications often used in pre and post marketing. The structure and content of each terminology will be discussed as well as demonstration of good coding practices. Common coding challenges will also be discussed and best practices employed in the industry.

Biography:

Joyce Yeung completed her anaesthetic training at Warwickshire School of Anaesthesia. Her PhD into strategies to improve quality of cardiopulmonary resuscitation was awarded the first PhD fellowship from Resuscitation Council UK. She is an expert reviewer for International Liaison Committee for Resuscitation and regularly contributed to the international resuscitation guidelines. She is a member of Editorial board of Resuscitation Journal and a faculty speaker at European Resuscitation Council Scientific Symposium. She is a Clinician Scientist in Anaesthesia and an NIHR Post-Doctoral Fellow at the University of Birmingham, and an honorary consultant in anaesthesia and critical care at Heart of England NHS Foundation Trust. As part of Perioperative, Anaesthesia, Critical Care and Trauma Trials (PACCT) group, she leads research studies in anaesthesia, critical care and resuscitation. Current research projects include the impact of anaesthesia on peri-operative outcomes, chronic pain, acute lung injury and education in resuscitation. Joyce is passionate about making research training more accessible for anaesthetic trainees and is the co-founder of West Midlands Trainee Research in Anaesthesia and Intensive Care Network (WMTRAIN) and a consultant advocate for Research and Audit Federation of Trainees UK (RAFT).

Abstract:

Good clinical practice and informed consent from patients are key pillars to the conduct of clinical trials. It is the responsibility of all researchers to ensure that the process of informed consent gives patients clear explanation of facts, implications, potential benefits and drawbacks of participating in a study. Clinical trials that involve patients who are acutely ill and receiving treatment can present a significant challenge to the researcher. Research in emergency medicine and critical care can pose many questions. When is the best time to approach patients or relatives? What is the best approach? How much information should be given? Should be approach next of kin? Who are personal consultee and professional legal representative? Should we retrospectively inform and consent patients who took part in research study? Drawing on past my own and my colleagues past experiences, I will present examples of recruitment strategies used in recruiting patients to emergency medicine, resuscitation, critical care and obstetric studies. I will discuss the waiver of consent for emergency medicine research. I will also highlight potential issues and pitfalls that can be avoided by taking correct steps in planning and protocol development stage.

Biography:

Teresa Melody is the Manager of the Academic Department of Anaesthesia, Critical Care, Pain and Resuscitation at Heart of England NHS Foundation Trust, UK. The Academic team consists of research fellows both local and international research nurses and research support staff. There are currently 20 Clinical research trials which are currently recruiting to time and target across the specialty.

Abstract:

The National Institute for Health Research (NIHR) was created in April 2006 under the 2005 UK Government strategy for health research: Best Research for Best Health. The government’s mission is to improve the health and wealth of the nation through research and to establish world class facilities to conduct leading edge research. To ensure these goals are met within the 10 year strategic plan, the NHS must be established as an international recognized centre of research excellence which attracts and develops the best research professionals to conduct people based research. The academic department of Anesthesia, Critical care, resuscitation and pain is located within a non-university based teaching hospital, Heart of England NHS Foundation trust comprising of 3 hospitals within the city of Birmingham, UK, these hospitals serve a local patient population of approximately 900,000 derived from a wide and diverse ethnic background. The trust actively supports clinical research across all NHS disease specialties. The department has been awarded the “academic” title by the Royal College of Anesthetists encouraging trainees’ participation in developing research skills. In conjunction with the NHS our research team has created a sound research infrastructure which is committed to developing best health for best research. During the past 10 years the department has developed a training pathway supporting our International colleagues to develop transferable knowledge of clinical research practices. An individual learning portfolio is developed. Training is provided across all clinical trial processes including; protocol development, grant funding, patient recruitment to clinical trials, data collection, data cleansing analysis and publication. My presentation will focus on how the department has developed a robust pathway to support the training needs of international research collaborators which has bridged the international research gap in turn aiding the development of international clinical trial development and recruitment.

Biography:

Joyce Yeung completed her anaesthetic training at Warwickshire School of Anaesthesia. Her PhD into strategies to improve quality of cardiopulmonary resuscitation was awarded the first PhD fellowship from Resuscitation Council UK. She is an expert reviewer for International Liaison Committee for Resuscitation and regularly contributed tothe international resuscitation guidelines. She is a member of Editorial board of Resuscitation Journal and a faculty speaker at European Resuscitation Council Scientific Symposium. She is a Clinician Scientist in Anaesthesia and an NIHR Post-Doctoral Fellow at the University of Birmingham, and an honorary consultant in anaesthesia and critical care at Heart of England NHS Foundation Trust. As part of Perioperative, Anaesthesia, Critical Care and Trauma Trials (PACCT) group, she leads research studies in anaesthesia, critical careand resuscitation. Current research projects include the impact of anaesthesia on peri-operative outcomes, chronic pain, acute lung injury and education in resuscitation. Joyce is passionate about making research training more accessible for anaesthetic trainees and is the co-founder of West Midlands Trainee Research in Anaesthesia and Intensive Care Network (WMTRAIN) and a consultant advocate for Research and Audit Federation of Trainees UK (RAFT).

Abstract:

The decline of UK academic anaesthesia research: Over the past decade, there has been increasing concern over the decline of academic anaesthesia in UK with dwindling numbers of academic departments, trainees undertaking research and reduction in successful grant funding. A 2005 review on the state of academic anaesthesia in UK and described the ‘crisis’ that the specialty was facing. The report identified multiple factors including modern medical training in anaesthesia, restructuring of university funding and excessive procedures to obtain bureaucratic approval for research. The need for trainee in research: Trainees represent an untapped and valuable resource that can both support on-going research and develop new research ideas. Trainees are enthusiastic and keen to get involved. Trainee networks set up by UK surgical trainees and have been extremely successful in spearheading and generating nationally funded trials (e.g. West Midlands Surgical Research Collaborative: ROSSINI trial, DREAMS study). Research network organisedby trainees with experience in research will be invaluable in mentoring and assisting those with less experience or less local support. National Institute for Health Research has created research training posts as part of Integrated Academic Training Pathways to make research training more accessible to trainees in all specialties including anaesthesia. Despite this progress, there is still a recognised lack of support for anaesthetic trainees in clinical training who want to participate in high quality research projects. A previous national survey revealed a broad interest in research by trainees (60%) but very few (8%) had any research experience. It was alarming that 41% of final year trainee failed to fulfil the curriculum requirement of completed audit, research involvement or systemic review. My talk will highlight the reasons that I believe we should include trainees in all aspects of research. I will describe my experience in setting up a regional network (West Midlands Trainee Research in Anaesthesia and Intensive Care Network, WM-TRAIN), which have grown into a national movement.

Biography:

James J. Hickman is the Founding Director of the NanoScience Technology Center and a Professor of Nanoscience Technology, Chemistry, Biomolecular Science, Physics, Material Science and Electrical Engineering at the University of Central Florida. Previously, he held the position of the Hunter Endowed Chair in the Bioengineering Department at Clemson University. Dr. Hickman has a Ph.D. from the Massachusetts Institute of Technology in Chemistry, as well as BS and MS from Penn State University in Chemistry. For the past twenty-five years, he has been studying the interaction of biological species with modified surfaces, first in industry and in the latter years in academia. While in industry he established one of the first bioelectronics labs in the country that focused on cell-based sensors and their integration with electronic devices. He has extensive experience in surface modification and surface analysis for biological and neuroscience applications, and the integration of these systems with MEMS devices and components for human body-on-a-chip applications. He is also the founder and current Chief Scientist of a biotechnology company, Hesperos, that is focusing on cell-based systems for drug discovery and toxicity. He has 110 publications and 18 book chapters, in addition to 26 patents.

Abstract:

One of the primary limitations in drug discovery and toxicology research is the lack of good model systems between the single cell level and animal or human systems. This is especially true for neurodegenerative diseases as well as for cardiac disease and cardiac side effect determination during the drug discovery process. In addition, with the banning of animals for toxicology testing in many industries, body-on-a-chip systems to replace animals with human mimics is essential for product development and safety testing. There is also a push to utilize in vitro systems to establish biomarkers to select subsets of the population for clinical trials and even to augment human testing during clinical trials. Our research focus is on the establishment of functional in vitro systems to address this need where we seek to create organs and subsystems to model motor control and cognitive function, as well as cardiac and liver subsystems. The idea is to then integrate microsystems fabrication technology and cellular components, with the aim of initiating and maintaining self-assembly and growth into biologically, mechanically and electronically interactive functional multi-component systems. Our advances in culturing human stem cell derived neurons, glial cells, muscle, liver and cardiomyocytes in a defined serum-free medium, and integreat them with MEMS devices suggest outstanding potential for answering questions during all phases of the drug discovery process using functional body-on-a-chip systems.

Biography:

Jingjing Yin received her Bachelor degree in Public Health Administration from Sichuan University in China. She obtained PhD in Biostatistics at University at Buffalo. Simultaneously, she was a Teaching Assistant for one Undergraduate Course and two Graduate Courses and then she became a Research Assistant working as a Biostatistician at Buffalo VA Medical Center and Statistical Consulting Laboratory at University at Buffalo. Immediately after completion of her PhD degree, she joined the Department of Biostatistics at Georgia Southern University. She has 10 publications and serves as the Associate Editor of Biometrics & Biostatistics International Journal.

Abstract:

In medical diagnostics, the ROC curve is the graph of sensitivity against 1-specificity as the diagnostic threshold runs through all possible values. The ROC curve and its associated summary indices are very useful for the purpose of evaluating the discriminatory ability of biomarkers/diagnostic tests with continuous measurements. Among all summary indices, the area under the ROC curve (AUC) is the most popular diagnostic accuracy index and it has been extensively used by many researchers for biomarker evaluation and selection. Sometimes, taking the actual measurements of a biomarker is very difficult and expensive while ranking them without actual measurements can be easy. In such cases, ranked set sampling which based on order statistics would give more accurate estimation than simple random sampling, since ranked set samples are more likely to span the full range of population (thus is more representative). In this study, Gaussian kernel is utilized to obtain a nonparametric estimate of AUC. Intensive simulations are carried out to compare the proposed method using ranked set samples with the one using simple random samples and the proposed method out performs universally with much smaller mean squared errors (MSE). A real data set is analyzed for illustrating the proposed method.

Biography:

James Stamey, PhD, is professor and graduate program director for the Department of Statistical Science at Baylor University. His research is primarily on Bayesian methods for measurement error and misclassification along with applications in pharmaceutical statistics and health economics.

Abstract:

We consider the case of comparing two or more proportions to a control in the case where interest is in an event such as an adverse event where the probability of occurrence is low. Also, we allow for potential misclassification in the assay. We investigate several different properties of a Bayesian inference procedure via simulation. The properties investigated include the following. We determine the bias and interval coverage for various non-informative priors to determine which prior is best. We also investigate the impact of misclassification on the bias and power. Finally, we overview a simulation based sample size determination procedure.

Biography:

Misako Nakashima has completed her PhD at the age of 25 years from Kyushu University and Postdoctoral Studies at National Institute of Dental Research, NIH, and Johns Hopkins University and New York University. She has published more than 80 papers in reputed journals.

Abstract:

The dentin-pulp complex does not regenerate spontaneously in pulpectomized adult tooth with complete apical closure as observed in root canal filling. Our preclinical work has demonstrated therapeutic potential of dental pulp stem cell (DPSC) subsets isolated by granulocyte-colony stimulating factor (G-CSF)-induced mobilization, known as mobilized DPSCs (MDPSCs) for complete pulp regeneration. We further assessed the safety and feasibility of autologous transplantation of human MDPSCs in pulpectomized tooth and evaluated cell therapy in a clinical trial. The trial was approved and monitored by the Japanese Ministry of Health, Labour and Welfare and by the Ethics Committes. Clinical-grade MDPSCs were isolated and expanded according to GMP conditions. The MDPSCs with granulocyte-colony stimulating factor (G-CSF) suspended in atelocollagen were transplanted into pulpectomized tooth. A total of 5 patients with irreversible pulpitis were enrolled and regularly monitored before and after transplantation for 24 weeks. Excellent quality control of the final individual product, MDPSCs was assured after freezing and thawing by the lack of contamination, abnormalities/aberrations in karyotype and the expression of stem cell markers, CD29, CD44, and CD105 and absence of CD31. The clinical laboratory and radiographic evaluations demonstrated no transplant-related evidence of toxicity and adverse events. Pulp vitality by electronic pulp testing turned a positive response within 4 weeks after transplantation (n=4). Magnetic resonance imaging (MRI) demonstrated the similar signal intensity in the root canal at week 24 to that in normal pulp. These results suggest that MDPSCs transplantation into the pulpectomized tooth is safe andefficacious for pulp regeneration in humans.

Biography:

Dr. Sanjay Kumar was completed his PhD from Jawaharlal Nehru University, New Delhi and postdoctoral research training at Indiana University, Indianapolis and University of Tennessee Health Science Centre, Memphis, USA, 2008-2012. Currently, Dr. Kumar is working as postdoctoral research associate at Jackson state University and his research focused on investigation of new target of Trisenox action in acute promyelocytic leukemia (APL) cells by modulation of cell cycle, p53 , signaling and apoptosis using mice model of APL. He has published 16 international research papers and also serving as member of editorial board and reviewer of five reported journals.

Abstract:

Trisenox (TX) alone or combination with all trans retinoic acid (ATRA) has been successfully used in the treatment of acute promyelocytic leukemia (APL) patients with highest survival rate. Clinical trials study of TX and their combination with ATRA was shown complete remission in both de novo and relapsed APL patients. However, the exact molecular mechanisms of its action through cell cycle arrest and apoptosis are poorly understood. We hypothesized that TX modulates cell cycle and apoptosis through activation of p53 and interaction of death domain-associated protein (DAXX), which disrupted the MDM2-DAXX-HAUSP interaction, MDM2 degradation and their self –ubiquitination. To test the hypothesis, we used western blotting, confocal imaging and other molecular techniques to identify new target of TX action in APL cells. We found that the expression levels of p53 and p21 increased significantly, whereas MDM2, DAXX and HAUSP decreased in a dose dependent. Our immunoprecipitation (IP) studies shown that they are well associated each other in cells and TX disrupted their association. After 21 days treatment of TX different doses (1.25, 2.5, 5.0 and 7.5 mg/kg body wt) in transgenic mice, we isolated liver tissue and bone marrow cells. We found, p53 was activated in a dose dependent TX treated mice. We conclude that TX disrupts MDM2-DAXX-HAUSP complex, release and degradation of MDM2 expression in APL cells. It leads to accumulation of p53, cell cycle arrest and apoptosis in APL cells. It is novel target for treatment of APL patients by TX and also designing of new drugs.

Biography:

Rucha Majmundar Mehta is an Independent GCP auditor (Free Lancer) since 8 years. She developed a Clinical Research Site in a privately owned small sized hospital and heading the site till date. She is providing QA consultation and training to various study sites and QA department of Pharmaceutical Companies. She conducts GCP Sessions during Investigators Meetings globally. She has participated in State, National and International Conferences of Clinical Research as a faculty. She is conducting GCP workshops for Clinical Research Professionals for on-going basis and during conferences. She is active member of EFGCP–AWP and RQA.

Abstract:

Fraud and misconduct in the research community occur more often than we would wish to believe. While it is impossible to provide a definitive figure for the frequency of its occurrence surveys provide us with consistently (and perhaps surprisingly) high estimates. Fraudulent clinical research affects the validity of data and impacts on the dignity, rights, well-being and safety of research participants. There are a variety of definitions of fraud and scientific misconduct. Often, the terms ‘fraud’ and ‘misconduct’ are used interchangeably. Generally, fraud describes acts of omission and commission, consciously not revealing all data and consciously altering or fabricating data. Such falsification of data can occur at any stage of the research process, from initial design through to reporting results. Fraud does not include honest errors or differences in opinion and the usual definitions include an element of intent. Repeated non-compliance with the study protocol and GCP may be considered as an example of misconduct, although the end result may well be similar to deliberate fraud. There are examples, from the beginning of a clinical trial to submission of a final manuscript, of dishonesty and deceit in general practice and primary care research. Patients have been invented to increase numbers (and profits) in clinical trials, ethical guidance on consent and confidentiality have been breached, and duplicate publication crop up from time to time. It is important for us all to be aware of the legal and ethical frameworks within which research is undertaken and of the steps that are available to prevent fraudulent and dishonest research being undertaken and written up.

Biography:

Helen Snooks is the Professor of Health Services Research in the Swansea University Medical School, UK. She is the Interim Director of the Swansea Trials Unit (STU) and leads the Patient and Population Health and Informatics (PPHI) research stream at Swansea University. Helen’s main research interests and expertise lie in the fields of Emergency Pre-hospital and Unscheduled Care, Clinical Audit and Effectiveness, and research support. The focus of her work is to plan, design and carry out evaluations of health technologies and new models of service delivery. Helen has a Bsc (Hons) Economics, Sociology, Statistics from University of Surrey with a PhD in Health Services Research ‘Post Traumatic Stress Disorder in seriously injured accident victims’ at the University of Sheffield in 2000.

Abstract:

Background: For patients to fully contribute their expertise to designing and conducting collaborative research, the interaction process with academic and organisational experts needs to be effective.
Objectives: To describe development and implementation of a model to enhance patient involvement in health and social care research.
Methods: Patients with chronic conditions were supported by a researcher to develop ways to enable their involvement in research about chronic conditions management. We explored experience of being involved in research through the model through interviews with participating patients, academics and senior managers responsible for health policy and services. Data were audio-recorded with consent and analysed using Interpretative Phenomenological Analysis.
Results: Patients established a pool structure, sharing support, information and skills development while available for recruitment to more than 30 collaborative research opportunities over three years. Interview respondents agreed the model increased the number and proficiency of patients involved in research. Academics and organisational managers perceived this was a credible and legitimate patient group. But recruitment and communication processes were confusing and interaction in research meetings was not consistently effective, they reported. Patients found the language and culture of research environments was off-putting and said they did not always know what they should and could contribute.
Conclusions: We developed a model which enhanced patients’ contributory expertise and strengthened some interaction processes when they were involved in research through collaboration. Further research training for patients, improved communication and better ways to match patients’ skills to research opportunities are needed to strengthen the model. Research teams should also clarify aims and roles of all collaborators when involving patients in research, to enable all expertise to be effectively integrated within research processes.

Biography:

Galya Atanasova completed her Ph.D. training in Cardiology from Department of Cardiology, Pulmonology and Endocrinology at Pleven Medical University, Bulgaria. She is a General Practitioner and Cardiologist in Trainee at Pleven Medical University, Bulgaria. She specialized in General Medicine from Pleven Medical University, Bulgaria during 1993. She has attended to many international events and presented her research work. She did many researches on metabolic syndrome and myocardial infarction of heart.

Abstract:

In a number of epidemiological studies, elevated blood pressure (BP) has been identified as a risk factor for coronary artery disease, heart failure, cerebrovascular disease, etc. The object of the study is to assess the degree of influence BP as a risk factor for myocardial infarction (MI) by logistic regression analysis. During year 2012 study in 99 subjects with survived MI, inhabitants of Pleven region in republic of Bulgaria was conducted. The following biomarkers are tested (fasting): HDL-cholesterol, serum triglycerides (TG) and total cholesterol (TC). Data processing is a logistic regression analysis. In our study developed two regression models. The first model includes SBP, level of triglycerides (Tg) and the level of total cholesterol (TC). An increase of 10% from the average value of the factor increase in OR for the occurrence of MI in men SBP is 2.05 times, and the level of TC was 1.28 times). The second model includes SBP, Tg levels and levels of HDL-cholesterol. Increase by 10% the level of Tg in little increase in the chances of occurrence of MI in women (1.05 times) and can therefore be concluded that Tg is not a risk factor for subjects studied.The most important risk factor for MI in our study is the increase of SBP. It has a great influence on the attitude of the chances of heart attack in men than in women.

Biography:

Ajay Francis Christopher, MSc (Molecular Biology & Biochemistry from Guru Nanak Dev University, India) served as PV Scientist, Senior Quality Scientist and Subject Matter Expert-PVQA for blue-chip pharmaceutical companies at a premier CRO in India. He has one Young Scientist Award and various appreciation awards to his credit. He successfully led various international projects (global transition in narrative writing for regulatory submission, customization and validation of Oracle Argus Safety 5.0.2, etc). He has published and presented research articles on microRNA expression in medulloblastoma and gliomas, plasmid profiling, unique mutations in beta-thalassemia and presently working on miRNAs targets of herbal extract with potentials of anti-cancer drug.

Abstract:

The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, evaluation, understanding, and prevention of adverse reactions to medicines or any other medicine-related problems. In 1893, The Lancet first reported an established drug safety reporting system for suspected adverse drug reactions (ADRs). Since then, the definition and scope of pharmacovigilance have evolved as a systems approach. Pharmacovigilance is a highly sensitive field as it involves monitoring of the safety of medicines and taking action to reduce risk and increase benefit. The pharmacovigilance data management starts with the data collection and, it is imperative to address the report origin, triage cases, enter information in drug safety database, make medical assessment, request report follow-up information and mode for regulatory submissions. All these stages require a high and complex degree of technical skill and judgment to ensure that accurate conclusions and right decisions are made during the establishment of benefit-risk profile for a product. A poor pharmacovigilance data management not only jeopardizes patient safety, it also increases the risk of investing in the development of wrong product which causes a huge loss to a pharmaceutical company. Therefore, it is very important to establish a robust pharmacovigilance data management system which complies with the stringent regulatory guidelines, global pharmaceutical norms and ultimately safeguard the pharmacovigilance end users, the patient. An ideal model would be implementation of business management software (e.g. Microsoft Dynamics NAV/SAP ERP) for better data management, process harmonization, enhanced data security and reduction in delay due to high manual dependence.

Biography:

Lee Truax-Bellows is a Founder, President and CEO of Norwich Clinical Research Associates Ltd. (NCRA). NCRA is a full service clinical contract research organization (CRO) based in upstate NY. Lee has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a Monitor, Medical Communications Associate, Project Manager, Senior Quality Auditor, GCP Trainer, and Regulatory and SOP Consultant. She has been involved in regulated research the past 25 years and currently specializes in product development, GCP auditing, and SOP development and training on regulated research and Good Clinical Practice. Lee is an active member of the Association of Clinical Research Professionals (ACRP), New York State MedTech Association and Society of Quality Assurance (SQA). Lee is ACRP certified as a Certified Clinical Research Associate (CCRA) and registered through SQA as a Registered Quality Assurance Professional in Good Clinical Practices (RQAP-GCP).

Abstract:

The latest emphasis from regulatory authorities within clinical study conduct is to design, develop and execute clinical studies using a Quality System Approach. While both the FDA and EU emphasize this approach, regulatory agencies provide little direction on how this can be achieved. The latest example of such an approach can be found within the FDA’s guidance on conducting a risk-based approach to monitoring. Risk management is an integral component of a quality system approach. As with a Quality System Approach many researchers do not have the knowledge or experience to conduct clinical trial risk management. This workshop will apply practical approaches and demonstrate associated tools and skills, to assist the participant in using a Quality System Approach within the clinical trial arena.

Biography:

Ajay Francis Christopher, MSc (Molecular Biology & Biochemistry from Guru Nanak Dev University, India) served as PV Scientist, Senior Quality PV Scientist, Trainer cum Mentor and Subject Matter Expert-QAPV for Blue Chip pharmaceutical companies at premier CRO in India. He has over 12 years of experience in Clinical Research and Development and has one Young Scientist Award and various appreciation awards to his credit. He has coded over 5000 ICSRs (SUSAR, serious, non-serious reports) and reviewed over 3000 ICSRs, narratives and SSUR. He successfully led various international projects (global transition in narrative writing for regulatory submission, customization and validation of Oracle Argus Safety 5.0.2, etc).

Abstract:

An adverse event (AE) for an investigational product could be generated during the clinical phase or reported spontaneously by a healthcare professional (HCP) or consumer via phone, fax, mail, literature or any social media. The ICH E2A has laid guidelines for the reporting of AE during clinical trials. Hence, pharmaceutical companies collect thousands of Serious Adverse Events (SAE) reports from a trial and individual case safety reports (ICSRs) from post marketing across many countries. An efficient way to manage the high load of safety reports is via adopting a process flow approach which consists of four basic steps: Case intake, case processing, case review and case reporting. The case intake from a clinical trial is done via SAE reports which are a part of case report form (CRF). The information is provided by a trained HCP and hence requires minimal handing before processing. Whereas, ICSRs are generated from the data mostly collected from non-medical personnel and hence the information is non-standardized and sometimes incomplete. During the second step i.e. case processing, the data is validated against four minimal criteria established by ICH i.e. identifiable patient, reporter, AE and suspected drug. In addition, the data is checked for possible duplication, entered onto safety database with case narratives and AE coded in compliance with the internationally defined standards. The third step i.e. the case processing is of great importance as the ICSRs are evaluated using the three standardized criteria: seriousness (death, life threatening, hospitalization, etc.), expectedness (whether the AE was expected under investigator brochure in a clinical trial or the product label for marketed product and causality assessment (degree of casual relationship between the AE and drug. These three criteria are essential for the establishment of expedited reporting of a safety report. The final step is the case reporting to the regulatory authorities within the timelines defined in the regulations. Hence, the importance of handling safety reports cannot compromised as it help to protect both patient safety and value of product assets of a pharmaceutical company.

Biography:

Helen Snooks is the Professor of Health Services Research in the Swansea University Medical School, UK. She is the Interim Director of the Swansea Trials Unit (STU) and leads the Patient and Population Health and Informatics (PPHI) research stream at Swansea University. Helen’s main research interests and expertise lie in the fields of Emergency Pre-hospital and Unscheduled Care, Clinical Audit and Effectiveness, and research support. The focus of her work is to plan, design and carry out evaluations of health technologies and new models of service delivery. Helen has a Bsc (Hons) Economics, Sociology, Statistics from University of Surrey with a PhD in Health Services Research ‘Post Traumatic Stress Disorder in seriously injured accident victims’ at the University of Sheffield in 2000.

Abstract:

Background: The SAFER programme conducts research into treating falls in older people; SAFER1 was a pragmatic cluster randomised controlled trial that examined a Computerised Clinical Decision Support system for paramedics, using a hierarchy of outcomes comprising death, unscheduled hospital admission, unscheduled ED attendance, and 999 calls. SAFER2 used a similar study framework to assess new protocols which allow emergency ambulance paramedics to assess and refer patients to appropriate community based care. Objectives: In SAFER2, all participants consent to follow up through routine medical records, and some by postal questionnaire. We consider (a) the characteristics of those providing data through two routes, (b) the consistency between data on hierarchy outcomes available through the two routes, and (c) any resulting effect on reported study outcomes. Methods: Routine medical records are available anonymously through the SAIL Databank in Wales and HSCIC in England; following successful linkage with study participants, data on each component in the hierarchy of outcomes is assessed at one month (for safety)and six months (for effectiveness). Data on QoL is also available at both time points. Results: Data from the two routes are broadly consistent; linkage problems are diminishing as experience develops. Respondents to postal questionnaires comprised approximately one quarter of study participants, and were generally younger & healthier than non-respondents. HTA of the SAFER2 intervention reaches similar conclusions with data from different routes. Conclusions: Routinely recorded data provides accurate information on the full range of study participants over multiple time points in follow-up, are based on increased sample sizes, and are more generalizable.

Biography:

Dr. Rania Abdelmonem Mostafa Khattab has completed her Ph.D in 2012 from Faculty of Pharmacy, Cairo University, Cairo, Egypt, Microbiology and Immunology Department. She is a lecturer at Microbiology and Immunology Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt. She has got Cairo University International Publication Award, Egypt in 2013. She has many teaching experiences for both undergraduate and postgraduate courses e.g. basic microbiology and immunology, pharmaceutical microbiology, quality control of herbal drugs and biotechnology. She has attended many workshops and some conferences with poster presentation in the Global Biotechnology Congress, Boston, MA, USA in June 2014. She published some papers in International Journals.

Abstract:

Purpose: To determine the association between chlamydial conjunctivitis and genital infection by Chlamydia trachomatis, Mycoplasma genitalium and Candida albicans, in addition to the possible relationship between cultured bacterial pathogens and oculogenital chlamydial infection.
Methods: This study was performed on 100 (50 symptomatic and 50 asymptomatic) women attending the Gynecological and Obstetric outpatient clinic of Alzahra hospital. Simultaneously a conjunctival swab was taken from these patients. Polymerase chain reaction (PCR) was done on DNA extracted from both vaginal and conjunctival swab samples. Culture for both vaginal and conjunctival swabs was also done.
Results: Candida albicans was the predominant organism isolated by culture in 20% and 40% of conjunctival and vaginal swabs respectively. By the PCR method, ocular Chlamydia trachomatis was present in 60% of symptomatic women, while genital Chlamydia trachomatis infection was present in 30% of symptomatic women. The results of this method also indicated that 25/50 (50%) vaginal swabs were positive with PCR for Candida albicans versus 15/50 (30%) were PCR positive in conjunctival swab. Mycoplasma genitalium was present in only 10% of vaginal swabs. A percentage of 73.3 of PCR positive ocular Chlamydia trachomatis cases showed no growth of pathogenic organisms in conjunctival swabs, and Staphylococcus aureus and Klebsiella spp. were genitally isolated in 53.4% of PCR positive genital Chlamydia trachomatis (26.7% each). Concomitant oculogenital PCR positive results for Chlamydia trachomatis and Candida albicans were 30% and 28% respectively.
Ocular Chlamydia trachomatis patients by PCR had also genital Chlamydia trachomatis in 50% of women; while genital Mycoplasma genitalium and Candida albicans were also present in 16.67% and 33.3% respectively in those ocular Chlamydia trachomatis PCR positive patients.
Conclusion: We can conclude that ocular Chlamydia trachomatis was associated with genital Chlamydia trachomatis in a high percentage of women followed by Candida albicans. Cultured bacterial organisms do not play a role in enhancement of Chlamydia trachomatis infection.
Key words: Chlamydia trachomatis - Mycoplasma genitalium - Candida albicans - vaginal swabs - polymerase chain reaction - Egypt.

Biography:

Professor Eliza Wong has an extensive clinical experience, an academic and researcher and currently an assistant professor of Nethersole School of Nursing, Faculty of Medicine, the Chinese University of Hong Kong. Professor Wong has a strong research interest in the field of e-health educational intervention in cardiac care and preventive care, cardiac rehabilitation and acute care. Her grants and international publications encompass a number of RCT studies in cardiac care and acute care including e-health educational intervention, pain management and wound care. She has published more than 25 peer reviewed journal articles and over 40 international conference papers.

Abstract:

Introduction: Coronary heart disease (CHD) is the leading cause of death globally, and e-health educational programs have been proved to be an effective support to patients. Considering the advantages of e-health programs, as well as the growing number of young patients with CHD in Hong Kong, we plan to conduct a randomized controlled trial (RCT) to investigate the effectiveness of a home-based interactive e-health educational intervention for patients with CHD in terms of improvements in total physical exercise, exercise adherence and self-efficacy, risk factor profile, psychological outcomes, and quality of life.
Methods and analysis: The RCT will be conducted in two government cardiac clinics in Hong Kong. Using a block randomization method, 438 eligible CHD clients will be randomly categorized to either the control group or the intervention group. All participants will receive usual care, but those in the intervention group will additionally receive the e-health educational intervention program. This program will consist of a one-hour educational session, one telephone follow up, and an e-health link on self-monitoring, which includes the recording of health measures and physical exercise across six months. Data will be collected at baseline, three-, and six-month intervals. The primary outcomes will be total physical exercise, which will be measured by the Godin–Shephard Leisure-Time Physical Activity Questionnaire. The secondary outcomes will consist of exercise efficacy and adherence rate, CVD risk profile, physical and psychological health outcomes (as measured by the Chinese version of the Health Survey Questionnaire and Hospital Anxiety and Depression Scale), and biological parameter. The data will be analyzed using mixed effect models and confirmatory factor analysis.

Biography:

Ruqaiya Al Balushi, PhD is an Assistant Professor in Clinical Nutrition at the Nutrition and Health Department, United Arab Emirates University (UAEU). Dr. Ruqaiya received her PhD in Clinical Nutrition from School of Medicine from University of Queensland in 2013. She did her MSc degree in Nutrition and Food Science from Sultan Qaboos University and her BSc degree from the University of Jordan. She worked as a clinical Dietitian from 2003-2005 and the head of the dietetics department at Royal Hospital in Oman from 2005-2014. She was an active member in the Nutrition Support Committee at Royal Hospital and helped in planning the Enteral Nutrition Support protocols at Royal Hospital. Her main research interests include enteral and parenteral nutrition support. She is specifically interested in the field of immunonutrition and pharmaconutrition and the therapeutic effect of glutamine supplementation in critically ill patients and other patient populations. She is also interested in Hospital Malnutrition. She has a number of publications in peer reviewed journals and two book chapters. Her main goal is to increase the awareness about the importance of Nutrition Support in UAE and Oman.

Abstract:

Introduction: Glutamine is the most abundant amino acid in the body acid in the bodyand has been considered non-essential in the past because it can be synthesized de novo. However, during stress and catabolic conditions such as multiple trauma and critical illness, the demand for glutamine increases and its concentration in plasma and muscle fall dramatically. Therefore, glutamine has been re-classified as an essential amino acid under such conditions. Despite the numerous clinical trials that have investigated the beneficial effects of glutamine supplementation in patients receiving enteral nutrition, the results are conflicting and inconclusive. This study aimed to determine the effect of intravenous alanyl-glutamine (Ala-Gln) supplementation on improving organ dysfunction and reducing infectious complications in multiple trauma patients receiving enteral nutrition.
Methods: A triple-blinded, randomized, controlled clinical trial was conducted to investigate the effect of intravenous Ala-Gln supplementation on organ failure, infectious complications and body composition in multiple trauma patients receiving enteral nutrition. Participants were randomly allocated (block-randomization) to receive either intravenous Ala-Gln (0.5 g/kg body weight; n=15) or intravenous placebo (n=15). Both groups received the same standard enteral nutrition protocol and the same standard intensive care unit care.
Outcomes/ Results: The primary outcome, which was the pattern of change in total Sequential Organ Failure Assessment (SOFA) score from day 2 to day 11 (over 10 days), was not significantly different between groups (intention-to-treat: regression coefficient 0.4938, 95% CI=-0.8113-1.7988, p=0.46; per protocol: regression coefficient 0.7220, 95% CI=-0.9758-2.4197, p=0.41). Although there was no significant difference reported in infectious complications with Ala-Gln supplementation, there was a slight reduction in ventilator-associated pneumonia (VAP) cases (2 vs. 6; p=0.21). Similarly, there were no significant differences in other secondary outcome measures (number of days of antibiotic use, number of ventilator-free days, ICU and hospital length of stay, protein levels, albumin levels and lymphocyte count). However, there was a significant increase in urea (p=0.001) and creatinine (p=0.01) levels in the Ala-Gln group. There was no significant difference in fat-free mass percentage (p=0.12) or fat mass percentage (p=0.12) between groups. Although there was a significant overall decrease in fat-free mass percentage over time in both groups (p=0.002), the rate of decline in the Ala-Gln group was slower, suggesting a beneficial effect.
Conclusion: Overall, the beneficial effect of intravenous Ala-Gln was not confirmed in this trial possibly due to a type II error. A rigorous, multicentre trial is needed to confirm the efficacy of intravenous Ala-Gln supplementation in preserving lean body mass, and reducing VAP and infectious complications in multiple trauma patients receiving enteral nutrition. Furthermore, the significant increase in urea and creatinine levels suggests further investigation about the safety of glutamine supplementation on renal function.

Biography:

Dr. Maha Mohssen has completed her M.D from Kasr El Eini Cairo University, she is a lecturer and researcher at the Micro Biology department at the Research Institute of Ophthalmology. Moreover, Dr. Maha also works as the head of the Bacteriology Corneal Unit at the Research Institute of Ophthalmology.
Dr. Maha has published several papers in reputed journals, and is also a member in the Egyptian Microbiology and Immunology Medical Society. In addition to the Egyptian Ophthalmological Society

Abstract:

Aim: To determine the possibility of the development of dry eye disease (DED) as a result of persistent infection with C. trachomatis and U. urealyticum in patients’ conjunctiva.
Methods: This study included 58 patients age range 20-50 years, diagnosed with DED. Control subjects were 27 non-dry eye group (same age range). Conjunctival scrapings were collected for bacterial culture and for detection of C. trachomatis and U.urealyticum by Direct Fluorescent Antibody (DFA) and Polymerase chain reaction (PCR) methods.
Results: C. trachomatis was detected in 65.5% and 76% of DED patients by DFA and PCR methods, respectively. U.urealyticum was found in 44.8% of DED patients by PCR method. Both organisms were identified in 37.9% of DED patients. Control subjects had C. trachomatis (22%) by DFA assay versus 7% by PCR; while U. urealyticum was detected in 3.7% by PCR. Conjunctival culture revealed coagulase negative Staphylococcus (CONS) the most common organism followed by Staphylococcus aureus, whereas gram negative Moraxella spp. was frequently isolated.
Conclusion: Results indicate C.trachomatis and U.urealyticum were detected in DED patients, and implicated in its development. Conjunctival microflora could show some potential value.
Keywords: Dry eye disease - conjunctiva - Chlamydia trachomatis - Ureaplasma urealyticum.

Biography:

Maha Haggag has completed her MD, PhD in 2004 from Cairo University School of Medicine. She is researcher and the head of Allergy Lab in the Microbiology and Immunology Unite, RIO. She has Patency application No.2006040138 at the Academy of Scientific Research and Technology, Egypt in 2006, the subject of Patency is Natural Allergenic Extracts for Specific Immunotherapy as Eye Drops. She published few papers in Egyptian and International Journals with poster presentation in the Unite For Sight Conference at Stanford University USA in April 2007. She worked as Exchange Visitor in the University of Florida, Gainesville, FL, USA for 6 months in 2014.

Abstract:

Infection of the eye results from either the acquisition of a virulent microorganism or uncontrolled growth of an existing organism because of lowered host resistance. In order to detect emergence of antimicrobial resistance it is important to use a practical, consistent, and standardized method that will allow comparison with national or international monitoring data. Results from antimicrobial susceptibility tests should be reported quantitatively rather than qualitatively, providing the minimal concentration of an antimicrobial required to inhibiting the growth of the Microorganism (MIC). This approach would facilitate the detection of small changes in antimicrobial susceptibility over time
Aim: The primary aim of this study is to validate the, performance, accuracy and utility of E test and verify the reproducibility of this convenient predefined gradient methodology for MIC determination in comparison with reference method as broth microdilution.
Evaluation: Evaluation is by testing the sensitivity of selected ocular bacteria; Staphylococcus aureus, coagulase negative Staphylococcus (CNS), Klebsiella and Pseudomonas aeruginosa to three antibiotics; gentamycin, ciprofloxacin and gatifloxacin by three independent assays; disk diffusion, brothmicrodilution and E-test.
Results: The MIC of gentamycin and ciprofloxacin measured by brothmicrodilution & E- test showed significant correlation for all selected bacteria except for CNS. While gatifloxacin showed no significant correlation between the two methods for all staphylococci and Pseudomonas. MIC of the three antibiotics measured by brothmicrodilution & E- test for Klebsiella showed significant correlation.
Conclusion: This study has clearly indicated that each susceptibility test has inherent advantages and limitations. Agar-based methods like E test and the agar disk diffusion represent valid methods compared to the broth microdilution method.

Biography:

Ting completed M.D at The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University. And he is an associate chief physician and Principal Investigator.

Abstract:

Background: Patients with hip fractures have the high incidence of delirium. Postoperative delirium (POD) leads to length of hospital stay, nursing requirements, increases healthcare cost, higher mortality and poor functional recovery. The majority of general anesthetic and sedative agents may favor POD. However, none of studies have investigated the effect of regional anesthesia and general anesthesia on the POD in elderly patients undergoing hip fracture surgery in China. Our research hypotheses are: Regional anesthesia may contribute to decrease the incidence of POD. Regional anesthesia may improve the outcome of elderly patient and reduce healthcare costs associated with POD. POD may result in poor long-term functional outcomes. Methods & Design: This phase 3 study is a multicenter, randomized, open-label and controlled trial. The primary objective of this study is to evaluate the incidence of POD for a period of 7 days after regional/general anesthesia in elderly patients undergoing hip fracture surgery diagnosed with the Confusion Assessment Method (CAM). The secondary objectives of this study are: To evaluate the type, severity and duration of delirium to evaluate the healthcare costs associated with POD; to evaluate the recovery parameters; to evaluate the long-term functional outcomes of elderly patient with POD. The target population are older patient (≥65 years) with hip fracture and planned hip fracture surgery; patient willing to complete this study. A total of 1000 patients will be randomized into 2 study groups (received regional anesthesia or general anesthesia) in the 9 participating centers clinical trial. Conclusion: In conclusion, the results of this comparative anesthesiological trial should allow us to detect whether anesthesia is related to POD rate. This information could ultimately help in selecting the most appropriate anesthesia in patients with high risk for POD. Trial status: Patients are being recruited in three centers currently. The study was initiated in September 2014. To date, 50 patients have been randomized (January 2015) in this study. Recruitment of patients is about 50% slower than expected. So the recruitment period of this trial will be extended from the September of 2015 to the September of 2016. Approximately three out of ten screened patients have been enrolled.

Biography:

Yifei Jiang received her MD and Ph.D. in Anesthesiology from Wenzhou Medical University and postdoctoral training at Cincinnati Children’s Hosptial. Her research focused on anesthetic neurotoxicity and fNIRS to detect and predict pain in children

Abstract:

Pain occurs in children after surgery or with certain diseases and conditions. Many children cannot communicate pain because they are too young or neurologically impaired. Based upon functional magnetic resonance imaging (fMRI), the prefrontal cortex plays an important role in pain perception; the fMRI BOLD signal in this area correlates with painful stimuli in healthy adults. Functional near infrared spectroscopy (fNIRS) is a non-invasive, portable, optical technology that measures changes in oxy-, deoxy- and total hemoglobin (HbO2, Hb, HbT) in the frontal cortex. Our prior study found that fNIRS detected frontal cortex HbO2 and HbT changes analogous to fMRI BOLD changes to painful stimuli in adolescents under anesthesia. In this study, we evaluated fNIRS to detect painful stimuli in young children under anesthesia and in adolescents with chronic pain. Our goal is to develop a non-invasive device to objectively measure pain to improve pediatric pain management.

Biography:

Petra Bagdi is a psychologist working in the Psychotherapy Department and Outpatient Clinic of the National Centre for Spinal Disorders Budapest in Hungary since 2010. She has being conducted her PhD in Health and Personality Psychology at the University of Pécs’s Doctoral School of Psychology since 2012. She becomes Clinical Psychologist and Hypnotherapist this year. Her research work includes: Pain management, psycho-education for chronic pain patients, assessments of psychological risk factors before surgery, psychological preparation for surgery, and effects of suggestive recordings during general anaesthesia.

Abstract:

There are different types of psychological interventions (e.g. psycho-education, behavioral therapy, cognitive therapies, supportive therapies) applied as part of comprehensive cardiac rehabilitation programs. The purposes of psychological interventions are to (1) screen psychological predictors of risk, such as anxiety, depression; (2) facilitate a return to normal living; (3) encourage patients to make lifestyle changes in order to prevent further events. A meta-analysis of 8,988 patients in 37 trials found that cardiac rehabilitation programs including psychological interventions resulted in a 34% reduction in cardiac mortality and a 29% reduction in recurrent MI at 1-10 years follow up.
Psychological interventions seem to be effective enhancing recovery rate. These findings emphasize the roll of psychologists in the prevention and rehabilitation of cardiac diseases.

Biography:

Margaret Kweku completed PhD in 2007 from the London School of Hygiene and Tropical Medicine (LSHTM) London UK. She is a senior Lecturer at the School of Public Health of the University of Health and Allied Sciences, Volta Region, Ho, Ghana. She has published more than 17 papers in reputed journals. She is currently involved in conduction field interventions trials and evaluation of health intervention programmes. She is also involved in drug and vaccine trials.

Abstract:

Background: Intermittent preventive treatment for malaria in children (IPTc) is a promising intervention to reduce the burden of malaria in sub-Saharan Africa. Artemisinin-based combinations are judged the best treatments for multi-drug resistance P. falciparum malaria. Some of these combinations could also be used for IPTc if they have some prophylactic effect. We investigated the therapeutic efficacy, tolerability and ease of administration of dihydroarthemisinin plus piperaquine (DHA+PQ) and artesunate plus sulfamethoxypyrazine plus pyrimethamine (Co-Arinate) compared with SP in asymptomatic malaria children. Methods: Five hundred and ninety (590) children aged 6 to 59 months with asymptomatic P. falciparum malaria were randomly allocated to the SP arm as single dose (n=150), Co-Arinate daily for three days (n=143), Co-Arinate 12-hourly for 24hours (n=149) and DHA+PQ daily for three days (n=148) arms. The children were followed up on post treatment days 1, 2, 3, 7, 14, 28, 42 and 63. Results: Day 42 PCR-uncorrected parasitological failure rate was higher in the SP arm than in the Co-Arinate daily, Co-Arinate 12-hourly and DHA+PQ arms [40.0% vs. 26.6%; RR 0.7; 95% CI: 0.54, 0.95; p= 0.015], [40 vs. 34.9%; RR 0.9; 95% CI: 0.70, 1.14; p=0.362] and [40% vs. 16.2% RR 0.5; 95% CI: 0.35, 0.70; p<0.000]. The difference was statistically significant in the Co-Arinate daily and DHA+PQ arms but not in the Co-Arinate 12-hourly arm. Co-Arinate daily reduced the incidence of malaria by 41.5% (95% CI: 15.3%, 59.5%; p=0.004), Co-Arinate 12-hourly by 10.3% (95% CI: -25.0%, 35.6%; p=0.521) and DHA+PQ by 61.1% (95% CI: 41.0%, 74.4%; p<0.000) compared to SP. Interpretation: Three days dose regimens are safer, more efficacious and provide longer protection compared to single dose or divided doses administered within 24 hours. Therefore, DHA+PQ and Co-Arinate daily for three days can be used for IPTc in Ghana.

Biography:

Arun Aggarwal received his Ph.D. in 2004 from the University of Sydney. He is currently working as a Visiting Neurologist at Concord Hhospital, a Chronic Pain Specialist at the RPAH Pain Clinic and a Rehabilitation Specialist at Balmain hospital. He is a member of the Royal Australasian College of Physicians, Australasian Faculty of Rehabilitation Medicine and the Australasian Faculty of Pain Medicine. His research has included Electrophysiological Studies in Familial Amyotrophic Lateral Sclerosis with his primary paper, “Detection of pre-clinical motor neuron loss in SOD1 mutation carriers using motor unit number estimation” being widely cited in the international literature. He was awarded the Australian Association of Neurologists Young Investigator Award for his presentation of this paper in 1999 and was nominated for the Delsys Prize in 2012. He has written 3 book chapters on this subject and has also published widely on a number of different topics. He currently has a number of research projects in the areas of Chronic Pain and Parkinson ’s disease. He is on the Editorial board of the Journal of Clinical Trials. He is the current Chairman of Australian & NZ Association of Neurologists Neuro-Rehabilitation Sub-Committee and on the Medical Advisory Board of Trigeminal Neuralgia Association (Australia).

Abstract:

Background: Ketamine is a non-competitive antagonist of N-Methyl-D- Aspertate (NMDA) receptors. It reduces NMDA-mediated nociceptive responses in dorsal horn neurons by binding to the phencyclidine (PCP) site of the NMDA receptor-gated ion channel. Chronic noxious input to the dorsal horn cells (mediated mainly by C-fibres) results in the removal of magnesium from the NDMA receptors and their activation by glutamate. This causes prolonged depolarization spinal neurons, which leads to central desensitization that may result in hyperalgesia (an excessive response to a painful stimulus and allodynia (a painful response to a normally non-painful stimulus). Ketamine helps to minimise excessively painful responses. Studies have also proven that antagonizing these receptors improves opioid receptors sensitivity, reduces opioid tolerance and suppresses opioid-induced hyperalgesia. Currently, there is no evidence on the long-term effectiveness of ketamine infusions in the setting of chronic pain.
Methodology: We performed a prospective study on 100 patients in the RPAH Pain Management Centre, to evaluate the long-term effect of a 3-7 day sub-anesthetics ketamine infusion with refractory chronic, non-cancer between 2007 and 2012. A proportion of patients who responded to the infusion were commenced on lozenges to see if the improvement could be maintained. The assessment was based on the evaluation of a standardized questionnaire performed over a telephone conversation. We sought to determine whether ketamine provides long-term benefit to:
-Reduce pain levels
-Reduce opioid requirements
Results: Our study showed that there was a significant reduction in pain intensity measured by VAS reducing from a mean of 6.38 before ketamine to 4.60 after ketamine infusion (p<0.005). There was also a significant reduction in opioid use from a mean morphine equivalent dose of 216 mg/day before ketamine to 89 mg/day after ketamine infusion (p<0.005). Current preliminary data suggests that around 35% of patients are able to maintain these opioid dose reductions with similar or reduced VAS scores, when placed on ketamine lozenges. This study answers several unresolved issues regarding the ketamine infusion. The most clinically important is whether it will be possible to maintain the ketamine induced pain relief for long-term, what the percentage of relapse is and what the response to ketamine lozenges is after a ketamine inpatient infusion.
Conclusion: The preliminary results of this prospective study suggest that a sub-anesthetic inpatient infusion of ketamine may offer a promising therapeutic option for long-term relief of chronic refractory non-cancer pain. The study also establishes the safety and efficacy of this novel approach and strongly supports ketamine being a useful and safe long-term analgesic option.

Biography:

Abstract:

In response to an increase in conduction of clinical trials, Egypt has established many research ethics committees (RECs) during the last few years. Egyptian Ministry of health established REC since 2007 and it has been acting since this time to review all clinical trials undertaken in Egypt in addition to all Master and Doctorate theses conducted in the governmental hospitals. This REC has created its own Standard Operating Procedures (SOPs) as well all the guidelines needed to be followed by the Egyptian researchers in their submission to the REC. In addition the ministry initiated a project to create "clinicaltrial.mohp.gov.eg" to register all the clinical trials conducted in Egypt. In order to control and supervise the Contract research organizations (CRO’s), we register all the CRO’s acting in Egypt. The total number of CRO’s registered in MOH till date are 16, the first CRO was registered in 2013. Although we are doing a lot of effort still many steps has to be taken to reach the standard we are aiming to: we undergo many training courses in the fields of research ethics, good clinical practice, research methodology and biostatistics to build the capacities of our health researchers to be able to conduct more clinical trials and to have Egypt as an attracting sites for them. We aim to have several clinical research centers with the needed qualified staff to conduct such trials.

Biography:

Dr. Jules Clement Nguedia Assob completed his PhD in Medical Biochemistry at the age of 31 years from the University of Yaoundé I in Cameroon. He is the Head of Department of Medical Laboratory Sciences of the Faculty of Health Sciences at the University of Buea. He has published over 70 papers in reputed journals and serving as Editorial Board member in many journals. He is the Treasurer of the Cameroon Society for Toxicological Sciences and a fellow of the International Foundation for Sciences since 2007. His fields of research are: Chemotherapy of infectious diseases; clinical biochemistry and Public health.

Abstract:

Clinical trials are experiments done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. Clinical trials are usually done on single products like antibiotics and antiretroviral drugs ; the combination of drugs in several therapeutics protocols like in Highly Active Anti-Retroviral drugs; anti-tuberculosis regimens and in the treatment of pathologies due to multidrug resistance germs are not usually considered. Various studies have shown that although individual compounds proven to be safe at clinical trials level tend to present adverse effects when introduce in therapeutic regimens involving more than one drug. The rationalization of the new strategies, however, requires great efforts in: standardization of mono- and multi-drugs preparations using all available high-tech methods. This paper presents present results of our various works on the “Incidence and Risk Factors of Anti-tuberculosis Drugs Induced Hepatotoxicity in HIV/AIDS Patients” and “on the “Variation of CD4+T-Lymphocyte Counts and Transaminases in HIV and HIV/HBV Co-infected Patients” advocating for prior clinical trials in similar diseases conditions.

Biography:

Abbas Alnaji was born in Baghdad 1962 and he had the Degree in Neurosurgery FICMS NS from University of Baghdad 1999. He is interested in research work and has eleven papers published in the field of surgical pathology causations.

Abstract:

Illnesses treated symptomatically had got causes! categorizing them as of not known etiology is for a while! One of the main pillars to disclose these causes is the clinical trial treatment CTT; it may exceed the other means, where it works when they are depleted. CTT has its civilization to be applied. It is the link among philosophy, clinical practice and applied sciences. Starts by looking for the truth, maintained by the perseverance and end by the smart perception. A wise man once said ‘’ the admiration prevents from increment’’ this is the philosophy. It refers to the satisfaction in what if we are on, will stop further discovery of diseases causation. The route is paved with difficulties, so needs insistence. Results of CTT are the meticulous harvest of each step of the route. For that, in my career, by applying the above three basis, I can say, good gain was obtained through; chronic low back pain, carpal tunnel syndrome, MRI signs had been satisfactorily knew their reality. and several others will be discussed in more reality in near future, the ignition for that was the clinical trials.

Biography:

Abstract:

Soya bean meal (SMB) and Soya bean protein lsolate (SOPI) were prepared from soya bean seeds. Based on the crude protein content, infant weaner foods was formulated on the substitution of SMB with SOPI and compared with three different commercial infant brand CFF, CFN and CFC, using weight gain, food conversion efficiency, relative organ weight and blood (haematological) constituents as response criteria. The result showed that 100% substitution of SMB with SOPI had the highest crude protein 16.6±0.1 g/100 g dry matter (DM), while among the commercial weaner foods CFC had the highest 16.2±0.1g/100 g DM. Infant weaner formulation of SMB or SPOI showed highest growth rate of 3.4±0.2 g/rat/day, was in the rats fed diet in which 75%of dietary SMB was replaced with SOPI. The least growth (1.1±0.2 g/rat/day) was in the rat fed commercial foods coded CFN or CFF. The relative organ weight (g/kg body weight) of the liver, kidney, spleen and heart of the rats were within normal ranges irrespective of whether they are fed SMB/SOPI or commercial foods. Haematological assessment showed no significant differences (p≥ 0.05) between the rat fed SMB/SPOI based diets and commercial brands with regards to the packed cell volume (PCV), red blood cell (RBC), white blood cell (WBC) and haemoglobin concentration (Hbc). Gross pathological observation of organs using such vital signs as colour, size, edge, and lesions revealed no abnormalities when compared with the controls.

Biography:

Abstract:

Thiamine deficiency has been documented to be prevalent in patients with diabetes mellitus, and correction of thiamine deficiency in this population may provide beneficial effects in the improvement of several cardiometabolic parameters, including prevention of impending complications secondary to chronic hyperglycemia. In this interventional study, we aim to determine whether thiamine supplementation is associated with cardiometabolic improvements in patients with diabetes mellitus type 2 (DMT2). A total of 86subjects (60 DMT2 and 26 age- and BMI-matched controls) were included and were given thiamine supplements (100mg/day) for 6 months. Anthropometrics and metabolic profiles were measured routinely. Serum thiamine and its derivatives were measured using high performance liquid chromatography. In all groups there was a significant decrease in total cholesterol after 3 months (p = 0.03) as well as HDL-cholesterol after 6 month thiamine supplementation (p = 0.009). Significant improvements were also observed in the mean serum levels of creatinine (p = 0.001), as well as thiamine and its derivatives in both serum and urinary thiamine levels across follow-up visits (p-values 0.002 and < 0.001, respectively). In the DMT2 group, improvements were observed in lipid profile [mean serum LDL- and total cholesterol with p-values 0.008 and 0.006, respectively], serum thiamine (p < 0.001), TMP (p < 0.001), TDP (p < 0.001), urinary thiamine (p < 0.001) and serum creatinine (p < 0.001). Thiamine supplementation is a promising adjuvant therapy for patients with DMT2. Longer clinical trials are needed to determine its protective effect in DMT2 complications.

Biography:

Anvita Karara is a Life Science Professional with expertise in Clinical Trial Design and modeling. She pursued her Masters in Biotechnology and Management from Carnegie Mellon University, USA. She has worked prior in this space with leading bio-pharmaceutical companies such as Genentech (a Roche company) and Onyx Pharmaceutical (an Amgen subsidiary).

Abstract:

Having a clinical study design which optimizes patient enrollment, site selection and clinical trial budget is one of the biggest challenges for bio-pharmaceutical R&D industry. Since the first trials of legumes in biblical times to the first randomized controlled trial of Streptomycin in 1946, clinical study designs are always aimed to answer a specific scientific question. The increasing clinical trial cost and cycle time in the life science sector has indicated that just answering a specific scientific question is not enough. It is necessary for the clinical study design to focus on potential downstream trial execution activities, patient enrollment and to prevent costly protocol amendments. In order to address these issues we need to combine the clinical study designs process with technology and leverage data. The clinical design software solutions integrate real world patient, cost and investigator data to perform clinical modelling and simulations. The real world modelling produces “what-if scenarios” which helps in analyzing cycle time, cost and risk tradeoff in present and future. Based on the clinical performance data and their internal algorithms, these tools can perform “tiering” of country and investigator sites in alternatives such as best, average and least optimum. They also ensure precise linkages occur between objectives, endpoints and procedures in the protocol. Predictive analytics and real world modelling design tools would help the clinical development teams to take data driven informed decisions. These tools will optimize patient enrollment and site selection, prototype multiple scenarios, reduce protocol amendments and help mitigate risk in study development.

Biography:

Iman GhodratiToostani has completed his master in neuroscience and cognition from Federal university of ABC and Currently he is PhD student in University of Sao Paulo. He is the director of Multidisciplinary Tinnitus rehabilitation Project as a Multicenter clinical study which recently granted by Sao Paulo research foundation and “Center for Mathematical Sciences Applied to Industry”, he is Member of Multidsciplinary Neuro-cognitive Laboratory as well. He has projected Neurofucntional tinnitus model since 2012, based on that he is developing several software in Tinnitus evaluation and Tinnitus rehabiliatation, and recently concentrated on decision support system development in Tinnitus field.

Abstract:

As an opened question how we can apply evidence-based TES research clinical trial protocol in routine clinical procedures? In order to be able to recommend any novel evidence-based TES protocol for clinical healthcare system, it is required to define a gold standard by means of independent specialist panel which we call them gold standard provider (GSP).Projecting clinical recommendations occurs through an ecosystem in which often many stockholders competing interests to have their own preferences or idea about delivery of the health care services. Despite of specific regulation in healthcare systems of different countries, we intend to propose a general model analogy to define, update, reaffirm, and, inactive of TES evidence-based clinical recommendation. The range of our model covers brain science frontiers and GSP ecosystems and their nitch platforms. The GSP processes of selecting topics, synthesizing evidence, deliberating and voting on recommendation, soliciting peer review, and finalizing recommendations have evolved over time. The purpose of current model is continually suggest and improve the methods of evidence-based TES reviews, to maintain transparency and objectivity and increase GSP efficacy. Accordance to Brain science frontier (BSF) knowledge development model, achievements in cognitive sciences, neuroscience, behavioral information, neuroimaging altogether with Electrical stimulation technologies may improve neuromodulation hypothesis and questions which may lead theoretical neurofunctional model of special disease. Brain scientists investigate on proposed hypothesis through several TES research clinical trials which may result in short-term or long-term effect on desired brain regions or network by mentioning following issues such as a)localization of stimulation, b) Mechanisms of action,c) Durability and Accumulativeness of effects, d) Reliable evidence and e) Combination with routine interventions (TAU). Outstanding effects accordance to proposed model can offer to GSP as a potential new topic of clinical recommendation. GSP consider weather really nominated TES topics are within the scope of GSPs’ and prioritizes the topics by mentioning specific criteria of public health, and, GSPs’ potential effect of clinical practice. We were simulated the TES clinical protocol recommendation model in order to evaluate its performance by applying full evidence review in Tinnitus TES rehabilitation.

Biography:

She is registered nurse and she had master degree in nursing (adult care nursing). She worked as teaching assistant in the Hashemite University (Jordan) for four years and as cardiac care nurse in King Abdullah University Hospital (Jordan) for four years.

Abstract:

Background: Patients with CHD often do not follow prescribed physical activity recommendations.
Aim: To assess the efficacy of behavioural intervention to increase physical activity in patients not attending supervised physical activity programmes.
Design: Randomised controlled trial comparing 6-month multi-component behavioural change intervention (n=85) with usual care (n=71). Intervention included one face-to-face individualised consultation, 6 telephone support calls (for goal-setting, feedback and self-monitoring) and 18 reminder text messages.
Setting: Two hospitals in Jordan, Middle East.
Participants: 156 patients with CHD (mean age 57.5 years; 54% male, 46% female).
Measurements: Outcomes measured at baseline and 6 months. Primary outcome was physical activity level. Secondary outcomes were blood pressure, body mass index, exercise self-efficacy for exercise and health-related quality of life.
Findings: Intervention and control groups were comparable at baseline. Moderate physical activity significantly increased in intervention group compared with control group (mean change (SD) of frequency: 0.23 (0.87) days/week versus -.06 (0.40), duration: 15.53 (90.15) minutes/week versus -3.67 (22.60) minutes/week and intensity: 31.05 (105.98) Metabolic equivalents (METs) versus 14.68 (90.40) METs. Walking significantly increased in the intervention group compared with control group (the mean change (SD) of frequency: 3.15 (2.75) days/week versus 0.37 (1.83) days/week, duration: 150.90 (124.47) minutes/week versus 24.05(195.93) minutes/week and intensity: 495.12 (413.74) METs versus14.62 (265.06) METs. Intervention participants had significantly lower blood pressure, lower body mass index, greater exercise self-efficacy and better health-related quality of life at 6 months compared with controls.
Conclusions: Multi-component behavioural intervention increases physical activity, and improves body composition, physiological and psychological outcomes in CHD patients not attending structured rehabilitation programmes.

Biography:

Abstract:

Background: Previous studies regarding rhythm control in patients with Atrial Fibrillation (AF) could not demonstrate the enough efficacies of available anti-arrhythmic drugs. The “upstream therapy” has emerged as a potential strategy for the prevention and treatment of AF. The use of angiotensin II receptor blockers (ARBs) and statins have been suggested to decrease new-onset AF in previous studies but which have remained inadequately explored. This study was designed to examine whether valsartan and or fluvastatin can reduce the probability of non-permanent AF in patients with hypertension. Methods/Design: The VF-HT-AF study is a multicenter, randomized, open-label, four-arm parallel group study with comparative evaluation of valsartan and fluvastatin as upstream therapies for the patients with non-permanent AF complicated hypertension. The primary endpoint is the difference in the development of paroxysmal AF into persistent and or permanent AF, persistent AF into permanent AF as well as the incidence of overall and persistent AF recurrence which are evaluated by 7-days ambulatory electrocardiograph monitoring (Holter) and patients’ diaries during 2 years follow-up. The secondary endpoints of this study include: (1) Fatal and nonfatal myocardial infarction; (2) Heart failure (NYHA III or IV); (3) Cardiogenic shock; (4) Serious bleeding which need to be hospitalization; (5) Malignant ventricular arrhythmia (including ventricular tachycardia and or fibrillation); (6) Revascularization therapy (CABG/PCI); (7) Radiofrequency catheter ablation of AF; (8) The changes of left atrial dimension on ultrasound echocardiography; (9) Stroke; (10) Cardiovascular mortality; and (11) All-cause mortality. The study will follow 1879 hypertensive patients with non-permanent AF who are treated at 15 medical centers throughout China and will provide available or useful clinical information. Discussion: The proposed study, evaluating the impact of implementing valsartan and or fluvastatin treatment on non-permanent AF is the first study in hypertensive patients’ complicated non-permanent AF in Chinese population. Results of this study will contribute to the upstream therapies of AF.

Biography:

Samina Qureshi is the Medical Director of the Health Sciences Division at PSI International Inc. She is a physician and is also pursuing an Advanced degree in Regulatory Science at the prestigious Johns Hopkins University. She is also an expert in various dictionaries, including the Medical Dictionary for Regulatory Activities (MedDRA), the World Health Organization Drug Dictionary (WHO-DD) and International Classification of Disease (ICD 9/10). She has supported Clinical and Pharmacovigilance activities at a senior level with over 20 pharmaceutical clients, the World Health Organization- Uppsala Monitoring Center as well as the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Adverse Events Reporting Programs Support; National Institutes of Health (NIH) and at U.S. Army Medical Materiel Development Activity (USAMMDA) providing training to data management staff.

Abstract:

The capture of safety data in the health care/life sciences context involves the use of many diverse terminologies. The purpose of these many terminologies is varied, ranging from capturing adverse events to categorizing diagnoses and procedures. The most important use of these terminologies involves the performance of good quality coding. Employing high quality and superior standards of coding translates into choosing terms within the respective terminology that most closely and accurately captures the concept observed or captured. Whether that concept is a product name in the case of pharmaceuticals or expression of an adverse event, the principle objective remains the same: Maintaining the integrity of information. The primary purpose of developing coding terminologies is to provide a uniform, consistent and reliable methodology to express concepts without losing expression of the integrity of the event. The correct use of coding terminology allows for the capture of “good” data and the production of aggregate results that lend themselves to reliable and meaningful analysis. Such a process ensures accurate signal detection that is neither diluted nor magnified. Because there are numerous terminologies, this workshop focuses on those described in the Medical Dictionary for Regulatory Activities (“MedDRA”) which is often used to capture adverse events after drug exposure and the World Health Organization’s Drug Dictionary (“WHO-DD”) which is used to capture concomitant medications often used in pre and post marketing. The structure and content of each terminology will be discussed as well as demonstration of good coding practices. Common coding challenges will also be discussed and best practices employed in the industry.