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

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.