2^nd International Conference on Clinical Trials August 22-24, 2016 Philadelphia, Pennsylvania, USA

Biography:

Tamera Norton Smith has twenty-six years of experience investigating and auditing severe GCP noncompliance. Tamera began her career in GCP and GMP environments in 1990 with the USFDA's Atlanta and Buffalo Districts. Her passion for FDA's mission led her to found her own business in 1999 to audit independently and teach responsible research conduct and ethical research practices. She founded Norton Audits in 1999. Norton was founded on the sole principle that research participants and patients should be safe and protected while vital and effective products are investigated with complete and accurate results and outcomes. Norton Audits provides independent facts for transparent decisions for GCPs.

Abstract:

Clinical research misconduct and fraud continues to impact solid research efforts and increases human research participate risks while participating in vital research efforts. Clinical research professionals continue to need knowledge, skills and prevention and detection skills to eliminate negative compliance outcomes. Every research professional has roles and responsibilities to care for those that participate. Every research professional has roles and responsibilities to ensure proper results are reported for key decisions on study results. Join with us as we dissect recent cases of scientific and medical misconduct and fraud. The instructor has twenty-six years of experience investigating and auditing misconduct and fraud cases. Case studies will be used to demonstrated time proven skills and techniques for the prevention of misconduct. Workshop Objectives: Attendees will be able to: 1. Apply legal standards to various types and forms of noncompliance to Good Clinical Practice (GCP) including domestic and international laws, regulations and guidance required by various governments. 2. Dissect misconduct and fraud cases for examples of both types and forms of misconduct and fraud. 3. Compare and contrast misconduct and fraud case studies. 4. Compare and contrast scientific and medical misconduct case studies. 5. Discern the similarities and differences in investigator and sponsor misconduct and fraud. 6. Apply proven monitoring and auditing skills and techniques used to prevent and detect misconduct and fraud. a. Skills and techniques i. Understanding Protocol ii. Data-Driven Trend Analysis iii. Risk-Based Approaches and Planning iv. Monitoring and Auditing Source and Data Skills and Techniques 7. Implement risk-based concepts and procedures to ensure risk mitigations and prompt identification for nonconforming performance and risk indicators.

Biography:

Stephen Hsu earned a PhD degree from the University of Cincinnati. He spent four years at Memorial Sloan-Kettering Cancer Center prior to a 4-year career change as a TV sports anchor for ESPN International while taught at the National University of Singapore. He is a tenured Professor at Georgia Regents University and serves as Course Directors for Nutrition and Biochemistry. He published more than 60 research articles and 8 books/book chapters. His contribution in translational studies on the benefits of green tea was recognized with multiple awards such as Georgia Bio Innovation Award and IADR/GSK Innovation in Oral Care Award.
 

Abstract:

Current non-toxic or “generally recognized as safe” (GRAS) countermeasures against viral entry into cells in the human body are often inadequate. The objective of this study was to evaluate a novel alcohol-based instant hand sanitizer formulation containing lipophilic EGCG (derived from green tea extract), in comparison to commonly used hand sanitizers either with or without alcohol. Standard 50% Tissue Culture Infective Dose (TCID50) assay was used for determination of virucidal capacity against poliovirus 1 (PV 1). In addition, neutralization by an ultrafiltration method was used to evaluate the mechanism of virucidal capacity. The results demonstrated that lipophilic EGCG formulations (with and without gelling agent) reduced the TCID50 by a factor of 6 (mean log₁₀–reduction of viral infectivity), 100-fold more than the reduction of viral infectivity (>4 log₁₀) mandated by internationally accepted standards. In addition, the virucidal effect of lipophilic EGCG formulations was associated with direct and irreversible inactivation of PV 1, rather than a reversible inhibition mechanism. In contrast, two commonly used instant hand sanitizers failed to reduce PV 1 viral infectivity by >4 log₁₀. In conclusion, lipophilic EGCG instant hand sanitizer formulations possess effective virucidal capability with the potential for use in novel disinfectant and antiseptic approaches, pending additional research and development.

Biography:

Annalisa Piccorelli received her PhD in Epidemiology and Biostatistics, with a concentration in Biostatistics, from Case Western Reserve University in 2010. Her dissertation work focused on joint modeling longitudinal and time to event data subject to left truncation with applications to cystic fibrosis. After completing her PhD, she has worked at the Cleveland Clinic, the University of Akron and is currently an Assistant Professor of Statistics at the University of Wyoming. In addition to joint modeling, her research interests include prediction models of health outcomes, often displayed with nomograms, clinical trials and mixed models.

Abstract:

During a clinical trial, we may know the results from past patients when assigning new patients to the treatments. It may not be ethical for equal allocation of treatment if we know that one treatment performs better than the other. Response-adaptive randomization methods use the information from past patients to increase the probability of the next patient receiving the better treatment. This paper compares the following three response-adaptive randomization urn designs: Randomized Play-the-Winner (RPW), Modified Play-the-Winner (MPW), and Birth-and-Death Urn (BDUI) with Immigration, to the traditional equal allocation (EA) design. Simulations were conducted to compare the power and allocation of patients to the more effective treatment. For every other sample size 30 to 210, 1000 simulations were run, each with the following three combinations of treatment and control success probabilities: (0.1, 0.3), (0.2, 0.6), and (0.5, 0.7). The allocation proportion increased as sample size increased for MPW for (0.1, 0.3), (0.2, 0.6), and (0.5, 0.7), and for BDUI and RPW for (0.5, 0.7). Because MPW allocated too many to treatment, power could not be assessed. For (0.1, 0.3), (0.2, 0.6), and (0.5, 0.7), power of BDUI, RPW, and EA increased with sample size. MPW tends to be unpredictable and can result in all of the patients being allocated to the better treatment. RPW allocates more patients to the better treatment than BDUI, but BDUI is more consistent in its allocations. The RPW and the BDUI designs produce allocations that have comparable powers to the EA design.

Biography:

João Paulo Tardivo is assistant professor of angiology and vascular surgery and director of the Center for the Treatment of Diabetic Foot in the Faculdade de Medicina do ABC. He graduated in medicine from the Medical School of ABC in 1976 and obtained his Master in Health Sciences in 2004 and PhD in 2013 in the same institution. Expert in vascular surgery since 1979, began his studies with medical lasers in 1987.  In mid- 1999 began to be interested in Photodynamic Therapy in Dermatology and superficial tumors and since 2009 has been doing research with the use of Photodynamic Therapy to treat Diabetic Foot. He has published 14 papers in reputed journals and developed an Algorithm to treat Diabetic Foot with Photodynamic Therapy.

Abstract:

Antibiotic therapy and debridement are the most used practices to manage infectious diabetic foot and usually culminate with some amputation. When infection is associated with vascular disease, the clinical pictures are more serious. The chance of healing without surgical intervention is quite remote. Antibiotics are necessary but diabetic nephropathy is usually present and antibiotics can worsen the clinical condition. It is clearly necessary to develop novel treatment strategies for this health problem. Photodynamic therapy (PDT) is a treatment modality that uses light to generate in situ reactive oxygen species and to cause death in any type of cell including bacteria. Therefore, foot infections can be treated with PDT. Several characteristics of PDT favor it uses to treat diabetic feet: It is a very efficient antimicrobial agent, even against resistant microorganisms avoiding development of resistance; it is applied locally avoiding systemic drug toxicity; it can be applied in outpatient regimens. We performed a clinical study to verify if PDT is an effective method to avoid amputation of infected diabetic feet. An inexpensive PDT protocol was developed and applied to 18 patients with osteomyelitis, classified as Grade 3 on the Wagner scale. Only one of these patients suffered amputation. In the control group, of 16 patients, all of them ended up suffering amputation. The rate of amputation in the PDT group was 0.029 times the rate in the control group and the difference is clearly statistically significant (p=0.002). Another study group with 62 diabetic patients with foot infections allowed the development of the Tardivo algorithm to access amputation risk. Three parameters were more important: Tissue oxygenation, location of infection in the foot and progression of osteomyelitis accessed by Wagner classification. We showed that the combined use of the algorithm and of the low-cost PDT protocol can decrease substantially the amputation frequency in diabetic patients.

Biography:

Saqib Javed has completed his MD (Research thesis) at University of Surrey, U.K. His area of interest is prostate cancer diagnosis and his research focussed on Prostate Histoscanning and Engrailed-2 that is a novel urinary biomarker for prostate cancer. He is currently a Urology Specialist Training Registrar in the Mersey region, Liverpool, U.K. He has published his research work in various peer-reviewed journals and presented at various regional, national and international conferences. He was awarded the best poster award for his presentation on Prostate Histoscanning™ at the European Association of Urology (EAU) conference, Stockholm in 2014. He is also a reviewer for British Journal of Urology International (BJUI) and World Journal of Urology (WJU).

Abstract:

Prostate Histoscanning^TM (PHS) is a trans-rectal ultrasound (TRUS) based technology that scans the prostate gland sequentially using a TRUS probe. PHS software then analyses back-scattered radiofrequency data following the TRUS scan. The manufacturers claim that PHS can distinguish between benign and malignant tissue based on their radiofrequency signature. Initial reports showed encouraging results with PHS. Subsequent studies were unable to reproduce these findings. Various studies were performed comparing PHS with TRUS biopsies, trans-perineal template guided biopsies, whole mount radical prostatectomy specimens and multiparametric magnetic resonant imaging. Initial studies in 2008 (Braeckman et al) and 2012 (Simmons et al) showed encouraging results for PHS in detection of prostate cancer. These studies included small number of highly selected patients and were un-blinded. More recently in 2014 (Javed et al) and 2015 (Porres et al), blinded studies of unselected and higher number of patients were performed in routine clinical practice that showed the inability of PHS to detect prostate cancer. Conclusion: Initial small and un-blinded studies on PHS reported encouraging results. However, subsequent independent and blinded studies with larger patient cohorts did not reproduce these findings and revealed that PHS failed to identify prostate cancer in routine clinical practice.

Biography:

Rimda Wanchoo has completed her Medical Training in Nephrology at Weill Cornell Medical Center and currently is an Assistant Professor of Medicine at Hofstra Northwell School of Medicine in New York, USA. She has published papers in onconephrology and toxicities of chemotherapy agents and their effects on the kidney. She also serves as an expert member for the Cancer and Kidney International Network (C-KIN).

Abstract:

Introduction: Novel targeted anti-cancer therapies have resulted in improvement in patient survival compared to standard chemotherapy. Renal toxicities of these agents are increasingly being recognized.

Aim: We studied the renal adverse events associated with oncologic targeted therapies.

Design: We studied all renal toxicities reported by selected novel targeted therapies to the FDA Adverse Event Reporting System (FAERS) 3^rd quarter of 2011 to 2^nd quarter of 2015. In addition we reviewed published literature and clinical trials to further understanding of renal toxicities with these agents.

Results: The number of adverse events reported was 2,943 during the years 2011-2015. For all agents combined, the most commonly reported events were metabolic disturbances. Of the 3 categories of events, 1,390 (47.3%) were metabolic disturbances, 1,243 (42.2%) were renal impairment and 310 (10.5%) were reports of hypertension. Hypokalaemia with 539 (38.7%) reported events, was the most common metabolic disturbance. Ipilimumab and cetuximab with 508 and 467 events, respectively, were the most common agents with reported adverse events. Events described in FAERS are reported by providers or patients and could have a reporting bias. In addition, not all demographic and co morbidity information is available, limiting the ability to explore nephrotoxic risk factors and certain other clinical characteristics.

Conclusion: Targeted therapies have a number of nephrotoxic adverse effects. Electrolyte disorders, renal impairment and hypertension are the most commonly reported events. Ipilimumab and cetuximab have the most nephrotoxic events reported from the targeted therapies.

Biography:

Dr. Eugene jamot Ndebia has completed his Ph.D. from Walter Sisulu University. He is a lecturer in medical physiology and biostatistics. As a researcher, he is looking at the relation between lifestyle and cancer of the esophagus in the Eastern Cape region of South Africa where the prevalence of this cancer is very high. Also, he has an interest in clinical trials research. He has published more than 18 papers in reputed journals and serving as an editorial board of many of them.

Abstract:

Ledebouria ovatifolia is a wild plant widely used for medicinal purposes including diarrhoea, stomach ache and gastric ulcer in Africa rural settings. This preliminary screening aimed to evaluate the healing effect of L. ovatifolia on experimental induced gastric ulcer in vivo. Indomethacin (50 mg/kg, p. o.), ethanol (2 ml/rat, p. o.) and stress were used to induce gastric ulcer. The anti-ulceration lesion index was calculated, also the macroscopic and histopathologic assessment were made. The results showed that oral administration of L. ovatifolia significantly decreases gastric ulcer as compared to control group. Macroscopic and histopathologic evaluation of ulcerated stomachs of L. ovatifolia treated groups showed a reduced area of gastric lesion, with moderate disruption of the gastric epithelium as well as the mucosa stromal cell. This finding suggested that L. ovatifolia can be used for its anti-ulcerogenic properties, which may support evidence for its traditional utilization.

Biography:

Chun Li has completed her MS on Analytical Chemistry from University of Waterloo, Canada. She has worked in DMPK groups within 3 different Pharmaceutical companies for over 25 years. She first joined Merck Research Laboratories in Canada in the year 1990, and then moved to Amgen in 2001 supporting both Discovery and Development DMPK. In 2008, she joined Genomics Institute of the Novartis Research Foundation (GNF) in San Diego, supporting discovery projects. She has authored or co-authored more than 35 papers in reputed journals and is a member of American Association of Pharmaceutical Scientists (AAPS).

Abstract:

Successful drug discovery relies on selection of drug candidates with good in vitro ADME and in vivo pharmacokinetic properties as well as appropriate preclinical efficacy and safety profiles. However, in vivo animal pharmacokinetic studies are still conducted in a traditional low throughput manner, and therefore, are often the bottlenecks of discovery projects in many pharmaceutical companies. This presentation will focus on the tiered in vivo PK approaches, including snapshot PK, rapid PK and full PK study designs which we have implemented to support our drug discovery efforts. In all 3 approaches, compound is dosed and analyzed discretely, thereby eliminating any drug-drug interaction concerns and analysis complications typically associated with cassette dosing or cassette analysis. The rapid PK approach uses several integrated and automated processes and sample pooling strategy to improve throughput, and has become our main stream in vivo PK approach in the lead optimization stage. These in vivo PK approaches differ in throughputs, capacities, the resources required, and are designed to address the varying needs of drug discovery projects at different stages of project progression. These approaches are well integrated within discovery research, allow tremendous flexibility and are highly efficient in supporting the diverse needs and increasing demand for in vivo profiling. Examples of each of the tiered in vivo PK studies will be illustrated.

Biography:

C.R. Sewani-Rusike completed her PhD studies at Michigan State University (East Lansing, USA) after which she studied Medicine at the University of Zimbabwe. Her primary research interests are in Reproductive biology – investigating the effects of indigenous plant foods and medicinal plants on reproductive function.

Abstract:

Metabolic syndrome is a growing problem worldwide and in South Africa. It encompasses obesity and its associated complications including dyslipidemia, hypertension, insulin resistance which predisposes to the development of type 2 diabetes. Food plants are being investigated as nutreucicals to combat obesity and its complications. Mormodica foetida is commonly used in the Eastern Cape of South Africa as a vegetable and condiment in food preparations. Additionally, it is used medicinally for the treatment of hypertension. In the present study, the effects of a hydroethanolic extract of M. foetida on metabolic syndrome were investigated in a high-energy diet-fed (HED) rat model at a dose 150 mg/kg body weight. After 12 weeks on HED, rats were treated daily with extract for five weeks. Untreated rats showed fat accumulation, glucose intolerance, increased blood pressure, increaed LDL, reduced sperm motility with no change in sperm count. Treatment with M. foetida improved all parameters with an increase in sperm count. However, no significant change in serum HDL cholesterol was observed in both untreated and treated rats. These results show potential for M. foetida in the treatment of obesity and associated metabolic disorders.

Biography:

Joe Martinez serves as the CEO of Center Point Clinical Services. He brings over 30 years of successful leadership experience in the pharmaceutical, biotech and Medicaid industries. He instituted novel industry programs utilizing RWE (real world evidence) and health outcomes information to communicate product value information to health care decision-makers. His research abstracts and poster presentations have been accepted by national and international associations including ADA, ASCP, AMCP, AGS, AADE and AACE.

Abstract:

Poor patient retention and medication compliance represent an ongoing challenge in clinical trials. Patients have many instructions to follow and can become frustrated easily. In fact, according to research by the Tufts Center for the Study of Drug Development, 49% of all patients randomized into a clinical trial quit before study completion. Clinical trials provide important and critical medical and clinical data that are required for FDA review and approval of a drug, device or procedure application. Addressing the patient’s need for medication information can increase protocol compliance; while increased patient retention and can have a beneficial impact on achieving primary endpoints and health outcomes. Statistical analysis of multiple clinical trials involving a chronic disease medication (diabetes) with clinical pharmacist medication counseling resulted in total of 21,582 CTRP (Pharmacist) calls were made to 3,124 clinical trial patients, 92.8% (2,900) of patients had at least one intervention, 45.7% (9,845) of clinical patient calls had at least one intervention and most frequent interventions were for concurrent medications (31.7%), miscellaneous concerns (24.9%), side effects (19.0%) and IVRS (19.0%). Clinical pharmacist medication counseling support was observed as a motivating factor for the patient to comply with study protocol directions and provided enhance patient retention. Increasing patient retention can save an average of $36,500 per patient and potentially shorten the study duration. Patient compliance increased by more than 25% percent and patient retention rates improved by 60 percent in these clinical trials, with results ranging up to 93 percent retention when compared to anticipated outcomes.

Biography:

Dr.Usta is a board certified pharmacotherapy and Nutrition specialist with extensive hospital and patient care experience as Pharmacy Director at AUBMC. She earned her Doctor of Pharmacy degree from Saint Joseph University and completed her Master at Belfast University, a Diploma of economic science from ESA and Leadership certificate from ASHP Leadership Institute. Leadership Institute at ASHP November 2010She is active member of various professional societies such as the American Society of Health-System Pharmacists, American Clinical College of pharmacists. For more than 25 years, she led the implementation of unit-dose distribution system, IV admixture units and clinical pharmacy services at AUBMC. Her primary research interest focuses on pharmacy practice, leadership, patient safety, antimicrobial use and pharmacoeconomic and pharmacovigilance. She is a frequent speaker at national and regional pharmacy events.

Abstract:

Purpose: The purpose of this study is to describe the experience of developing and implementing a pharmacy SharePoint as a single resource point to ensure effective and user-friendly communication and documentation of clinical interventions in a tertiary care center.

Background: The American University of Beirut Medical Center is a 350-bed capacity tertiary care teaching hospital in Lebanon. The pharmacy operates 24/7 with a Comprehensive Unit-based model where the pharmacists are assigned to adults, pediatrics, oncology, operation and night shift teams. This new structure led to increased challenges in communicating information within the department; communications was mainly through emails, multiple steps to reach references, and manual documentation to capture and track clinical activities (e.g. clinical rounds, chart documentation, time spent at the unit, follow up on restricted antimicrobial use and multidisciplinary meetings).

Methods: The configuration of the pharmacy home page and the content was agreed upon with the IT department and the pharmacists’ team leaders. The home page includes links to frequently utilized external (e.g. Micromedex, Medscape, out-patients’ formulary for third party-payers) and internal information (e.g. policies and procedures, order sets and protocols). Within the clinical services area are charts, standardized drip protocols, guidelines, stability sheets, compounding instructions and formulary applications include scheduling, calendar to reserve annual vacation, and parenteral nutrition software. Likewise, announcement section with temporary links was added to the home page to draw attention to important but transient information, such as an announcement for drugs in shortage, availability of newly approved drugs. Hierarchy of restriction was set with different access levels as owners, members and visitors and an alert setting was customized to provide e-mail alerts when information is updated or added. Quick launch buttons to document clinical activities and place follow up note on the inpatients’ dashboard using a scroll down option was created with the ability to generate reports to compile and analyze the data which is currently under development to be accessible through ipads and smart phones. The major future challenge is to persuade the pharmacist to make use of it. Future development will include training material and annual competency programs for pharmacists and technicians.

Results: After site initiation and training were completed, staff pharmacists found that SharePoint an improved method of document storage and communication. Survey to get staff feed-back is planned after full implementation.

Conclusion: Pharmacy SharePoint offers many applications to improve communication and achieve real-time capture of meaningful benchmarking data, but staff adoption and utilization of this resource will be the keys to success.

Biography:

Dr.Krishnan, did his post graduation in pharmacology from prestigious Stanley Medical College, India. He is research cordiantor of Saveetha Medical College. I have been engaged in medical teaching, functioning as consultant for CROs and Ethics committees.I have fetched prizes for research presentations in various proceedings and has five publication in Thomson Reuters, PUBMED and four papers in SCOPUS indexed journals.

Abstract:

Objectives: To evaluate the current knowledge about code of ethics involved in biomedical research To assess the researcher’s knowledge on informed consent process doing biomedical research.

Methodology: This cross-sectional study was conducted using validated questionnaire between January and April 2016. Questionnaire consists of two sections; in first section knowledge of basic ethical principles of human research was elucidated. In the second section, specific questions regarding informed consent process was asked to our study population of our sampling unit using random sampling method.

Results: Out of 250 biomedical postgraduates, 165(66%) researchers were found to have adequate knowledge about basic ethical principles.113(45.2%) researchers found to have knowledge on informed consent process and 137(54.8%) researchers still need to enlightened on the same. Subgroup analysis showed this significant difference (p < 0.05) seen between first and final year postgraduates; the later possessed more knowledge of biomedical principles.103 (41.2%) researchers have attended special workshops related pertaining specifically for bioethics.

Conclusion: Our study reflected satisfactory trend among Indian biomedical postgraduates about bioethics; however workshop and training should be emphasized for fresher’s at an earlier stage of their curriculum which will facilitate them to conduct their thesis with ethical concern from the inception. Bioethics lessons should be conducted for all biomedical researchers periodically to update the amendments

Biography:

Praveen Oberai has completed her BHMS from Delhi Board, MD from Agra University and Post-graduate diploma in Bio-ethics and IGNOU in collaboration with ICMR. She is working in Central Council for Research in Homoeopathy Headquarters, a premier institute of research through Homoeopathy, for more than 25 years and is heading the Department of Clinical Research. She had been actively involved in preparation of evidence based protocols prepared in consultation with the scientists of allied sciences, homoeopathic experts and bio-statisticians. In addition to this, she is also coordinating the Public Health Program of Ministry of Health and Family Welfare: Integration of Homoeopathy/Yoga in National Program for Prevention and Control of Cancer, Cardiovascular diseases, Diabetes and Stroke. She has to her acclaim more than 36 papers published in national and international journals of repute. She has also presented papers in various national and international seminars in India and abroad on subjects like research methodology, activities of CCRH, role of Homoeopathy in various disease conditions and outcome of various clinical research studies conducted by the council.

Abstract:

Objectives: To evaluate homeopathic treatment in the management of diabetic distal symmetric polyneuropathy.

Methods: A prospective multi-centric clinical observational study was carried out from October 2005 to September 2009 by Central Council for Research in Homeopathy (CCRH) (India) at its five institutes/units. Patients suffering from diabetes mellitus (DM) with symptoms of diabetic polyneuropathy (DPN) were screened, investigated and enrolled after fulfilling inclusion/exclusion criteria. Patients were evaluated by the Diabetic Distal Symmetric Polyneuropathy Symptom Score (DDSPSS) developed by the Council. A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in 30, 200 and 1 M potency on an individualized basis. Patients were followed up regularly for 12 months.

Results: Out of 336 patients enrolled in the study, 247 patients were analyzed. All patients who attended at least three follow-up appointments and baseline curve conduction studies were included in the analysis. A statistically significant improvement in DDSPSS total score (p=0.0001) was found at 12 months from baseline. Lycopodium clavatum (n=132), Phosphorus (n=27) and Sulphur (n=26) were the medicines most frequently prescribed. Adverse event of hypoglycemia was observed in one patient only.

Conclusion: This study suggests homeopathic medicines may be effective in managing the symptoms of DPN patients. Further studies should be controlled and include the Quality of Life (QOL) assessment.

Biography:

Sheraz Ali has completed his MPH degree on scholarship from University of Eastern Finland and PharmD from Baqai Medical University. He is currently working as a Researcher at Pharmaceutical Care Services, King Saud Medical City, Ministry of Health, Saudi Arabia, and involved in several clinical research projects. He also worked as a Clinical Research Associate in CRO and pharmaceutical industry and was a part of local and international clinical trials. He is a registered researcher in Saudi Arabia and also a member of International Society for Disease Surveillance (ISDS).

Abstract:

The clinical trial is an important type of research design in the spectrum of translational research. The extent to which clinical trials are conducted is a reflection of the level of advancement that exists within a healthcare system – a single provider, an organization (e.g. a hospital), or a national healthcare system. This study aims at describing the clinical trial activity within the Kingdom of Saudi Arabia since 2000 through reviewing those trials that have been registered with ClinicalTrials.gov in that time period. Since February 2000, 405 trials have been registered with ClinicalTrials.gov. These trials fall into one of 22 different ICD-10 codes, and with the top four being neoplasms (92), diseases of the circulatory system (57), endocrine, nutritional and metabolic diseases (46), and diseases of the respiratory system (25). Among the 405 trials, about half (200) were classified as trials with both safety and efficacy endpoints. Fifty-two percent were phase IV trials and 28% were phase III. About 64% were randomized, and with about equal numbers of those trials coming from industry (86) and university sponsors (85), and smaller numbers coming from hospitals (51) and other sponsors. Among the 185 university- or hospital-sponsored trials, the most common was a phase IV neoplasm trial (11) and next being a phase IV trial of diseases of the circulatory system (9). A total of 24 phase III university- or hospital-sponsored trials have been registered during the 15-year time period. With a population approaching 30 million and very large annual healthcare expenses, it would appear that the level of clinical trial activity within the Kingdom during the past 15 years has been rather paltry. The emphasis has been on post-marketing phase IV trials. The academic setting (i.e. universities and hospitals) has seen a new trial registered every 11 months on average. This study is solely based upon the information as registered in ClinicalTrials.gov. There is the possibility that other trials not registered could exist. However, it is thought that the resource would include those trials of a higher quality and more rigorous.

Biography:

Ramandeep Kaur Brar has completed her B.Pharm and currently pursuing MSc in Clinical Research at University Center of Excellence in Research, Baba Farid University of Health Sciences, India. She has published one chapter in book and one Paper “Scope and Bottlenecks in Clinical Trials of Herbal Drugs” in the Journal of Pharmaceutical Research.

Abstract:

Ethics committee is supposed to play a great role in safe human research. It is mandatory that all research projects related to health sciences with involvement of patients/subjects should be approved by IEC before commencement. The data available reflects the low percentage of awareness amongst the routine project investigator. Being inclined towards medical education only, awareness amongst faculty members of medical colleges towards ethics committee is also expected not up to the mark. Indian Council of Medical Research has launched and funded development of Multidisciplinary Research Unit (MRU), a scheme for igniting research component in various medical colleges of India. Keeping in view the above situation, a study was designed to check the awareness about the composition, review procedure and functioning of IEC amongst the research scholars/teachers in government medical colleges of Punjab. The information was sought in form of a questionnaire from a total of 50 participants. From the study it was observed that only 10% had undergone ICH-GCP training. A few participants (6%) served as member of IEC and demonstrated a very poor knowledge index about IEC. Only 68.5% participants were aware about its composition and majority of respondents (86%) felt that there was a need of training before becoming a member of IEC. From the data it is very clear that there is strong need of training to faculty of medical colleges towards institutional ethical committee. There is a need to inculcate the IEC-ICH guideline in curriculum of post-graduates medical students and medical teachers.

Biography:

Supreet Kaur Gill has completed her Bachelor of Dental Surgery from Adesh Institute of Dental Sciences and Research, Baba Farid University of Health Sciences, India. Currently she is pursuing her Post-graduation (MSc) in Clinical Research from University Centre of Excellence in Research, Baba Farid University of Health Sciences, India. She has published one paper in Asian Journal of Pharmaceutics and Clinical Research.

Abstract:

Clinical research is making toiling efforts for promotion and wellbeing of the health status of the people. There is a rapid increase in number and severity of diseases like cancer, hepatitis, HIV etc., resulting in high morbidity and mortality. Clinical research involves drug discovery and development whereas clinical trials are performed to establish safety and efficacy of drugs. Drug discovery is a long process starting with the target identification, validation and lead optimization. This is followed by the preclinical trials, intensive clinical trials and eventually post marketing vigilance for drug safety. Softwares and the bioinformatics tools play a great role not only in the drug discovery but also in drug development. It involves the use of informatics in the development of new knowledge pertaining to health and disease, data management during clinical trials and to use clinical data for secondary research. In addition, new technology likes molecular docking, molecular dynamics simulation, proteomics and quantitative structure activity relationship in clinical research results in faster and easier drug discovery process. During the preclinical trials, the software is used for randomization to remove bias and to plan study design. In clinical trials software like electronic data capture, Remote data capture and electronic case report form (eCRF) is used to store the data. The eClinical, Oracle clinical are softwares used for clinical data management and for statistical analysis of the data. After the drug is marketed the safety of a drug could be monitored by drug safety software like Oracle Argus or ARISg. Therefore, softwares are used from the very early stages of drug designing to drug development, clinical trials and during pharmacovigilance. This review describes different aspects related to application of computers and bioinformatics in drug designing, discovery and development, formulation designing and clinical research.

Biography:

Yanning has received a PHD degree in statistics from Cornell University. She is a principle statistician at Johnson and Johnson. She has published more than 20 papers in statistics, clinical trials and biology

Abstract:

The basic problem that causes the frequent failure of a standard randomized parallel placebo-controlled clinical trial with a high placebo response rate is the underestimation of the treatment effect by the observed relative treatment difference. A two-period sequential parallel enrichment design has been proposed where the first period is a standard parallel design and at the end of the first period, the placebo non-responders are identified and re-randomized in the second period. Based on such a design, available methods have primarily focused on testing either the first period treatment null hypothesis or the global null hypothesis defined as the joint period 1 and period 2 treatment effect null hypothesis by a test statistic which is either derived from a combined statistic or defined directly as a weighted z-score where the weights are functions of some population and design parameters satisfying certain power optimality criterion. However, in some cases, it is not clear what their combined statistics are estimating and in others, the combined statistics are estimating the apparent treatment effect; but generally, there is no discussion of the need to provide a proper assessment of the treatment effect for the intended study population. It should be clear that an appropriate assessment of the treatment effect for the intended study population is critical for the benefit/risk analysis as well as the proper dosage recommendation. Any benefit/risk analysis and dosage recommendation that are based on an apparent treatment effect from a standard parallel design such as the first period of a sequential parallel enrichment design tend to underestimate the benefit/risk ratio which in turn may lead to overdosing recommendation. It is the purpose of this paper to introduce the concept of an adjusted treatment effect which is derived by adjusting the apparent treatment effect from the first period of a sequential parallel enrichment design with information from the second period subject to a consistency condition. The adjustment properly compensates for the high placebo response rate. It is proposed that this adjusted treatment effect should be used to assess the treatment effect for the intended study population and should be the basis for the benefit/risk analysis and the dosage recommendation.

Biography:

David R Jones, BSc, MSc, EurBiol, CBiol, MRSB, MTOPRA, European Registered Toxicologist After spending 8 years in Contract Toxicology and 11 years as a Toxicologist in the Pharmaceutical Industry, I currently work as an Expert Pharmaco-Toxicologist within the Licensing Division of the Medicines and Healthcare products Regulatory Agency (MHRA) in London, whom I joined in 1996. My current role principally involves assessing nonclinical data for Clinical Trial Applications, both non-biological and biological. A further aspect of my job is to offer regulatory advice to companies on behalf of the MHRA or the EU’s Committee for Human Medicinal Products (CHMP). I am one of the UK’s accredited non-clinical experts to support the CHMP and am the UK representative on the EU’s Safety Working Party (SWP). I represented the EU in the ICH revision of the M3 Guideline and on the ICH S10 Guideline. I am now EU Rapporteur on the new ICH S11 (Juvenile Animal Studies) guideline and the Q&A document for ICH S3 (Toxicokinetics). I am also a guest lecturer at the University of Surrey, the University of Wales, and the University of Leicester and a frequent presenter at conferences around the world.

Abstract:

The EU is introducing legislation aimed at harmonising the way in which clinical trials conducted in the Europe are authorised and at improving the reliability of data generated in those trials. The Regulation replaces the EU Clinical Trials Directive (EUCTD), which was approved in 2001 and implemented in May 2004. The regulation will introduce and include a number of key provisions. There is an authorisation procedure for clinical trials based on a single submission dossier via a single EU portal, an assessment procedure leading to a single decision on all aspects per member state, rules on the protection of subjects and informed consent, and transparency requirements. Other aspects include more detailed safety provisions, new indemnity provisions and a category for low interventional trials. The new regulation also intends to make it easier for pharma companies to conduct multinational clinical trials. The talk will cover review the new Regulation, highlighting what will change from the Directive and advise companies how to gear up for its implementation.

Biography:

Jane A Otado has completed her PhD in Medical Sociology/Social Demography from Howard University and Postdoctoral studies from Centers for Disease Control and Prevention (CDC). She is currently the Associate Director of Regulatory, Ethics Knowledge and Support (REKS), a component of the Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS), a CTSA research grant funded by National Institute of Health (NIH). She has held various health services research workshops, research ethics, GCP and human research protection training relative to compliance. Her area of research interests include access to and availability of health care particularly as it relates to minority health, adolescent health, prenatal care utilization, elderly African American and access to health care, minority participation in clinical trials. Her recent research involves post-consent understanding among at risk minority population and recruitment strategies for recruitment and retention of African American population into clinical trials and research participant satisfaction surveys. She serves on the Howard University biomedical IRB, on the GHUCCTS protocol review committee and a Member of the GHUCCTS Steering Committee.

Abstract:

Purpose: To identify successful recruitment strategies, challenges and best practices for researchers to engage African American communities in clinical studies taken into consideration target participants’ culture and context. Methods: We reviewed 50 studies conducted from 2001-2012 at an inner-city research center to determine the type, duration, anticipated enrollments and actual enrollments. Survey was sent to study coordinators to obtain data on recruitment and retention strategies, challenges and dropout rates. We also interviewed 25 study coordinators on challenges and strategies. Results: Of the 50 studies, 24 had completed recruitment at the time of this report. The completed studies achieved a median recruitment rate of 88% [range: 50-110]. Successful recruitment and retention strategies included field-based strategy and snowballing. Major barriers were distrust, compensation, education disadvantage, lack of interest and inability to have study partner. Strategies to reduce barriers included providing informational sessions, disseminating newsletters about study outcomes. Best practices include being culturally sensitive including demonstrating a caring attitude and being responsive to participants needs. Conclusions: Cultural competence is critical in order to design and implement successful recruitment strategies in this population. Research teams should comprise of multi-ethnic staff, involve the community, demonstrate trust and deliver concise education of the research endeavor.

Biography:

Abstract:

Vitamin D, commonly known as sunshine vitamin, is both indispensable and vital for human beings. The prevalence of vitamin D deficiency (VDD) is on the rise globally including the sunny regions such as in the UAE. The aim of this study was to examine the relation between the degree of chronic vitamin D deficiency as a risk factor of the incidence of type 2 diabetes mellitus among adult populations. This is a single-centre observational retrospective cohort study conducted in a tertiary hospital in the UAE. It was mainly based on reviewing the electronic data-base and medical records of all chronic patients that match the inclusion criteria. The inclusion criteria of this study included all adult patients aged between 18 and 55 years old, tested for vitamin D level, visited the practice at least three times in the past year. The exclusion criteria included renal failure patients, patients who had malabsorption disorders and those with T2DM risk factors. A sample size of 35,000 adult patients who were screened in a period of 12 months for vitamin D level was selected using the lab database. Patients were checked against the inclusion criteria and of them, only 391 patients met the inclusion criteria. Other diabetes risk factors such as obesity, family history, pre-diabetes, presence of co-existing hypertension and dyslipidemia were also reviewed and excluded. The results of this study showed that a total of 56 patients [14% (95% CI 10.56- 17.44)] had normal results compared to 335 patients [86% (95% CI 82.56-89.44)] who had a chronic vitamin D deficiency. In addition, the results showed that 17% (95% CI 13.28- 20.72) of the 391 patients had mild vitamin D deficiency (VDD), 31% (95% CI 26.42- 35.58) moderate VDD and 38% (95% CI 33.2- 42.8) severe VDD. A total of 32% of patients with severe vitamin D deficiency developed diabetes compared to only 16% from patients with normal vitamin D deficiency and statistically showed significant difference from all other VDD groups as to developing T2DM. This indicates that the more the severity of vitamin D deficiency, the more the susceptibility to develop T2DM. Of a note, in the prevalence of severe chronic VDD, female patients showed significantly higher percentage (61%) of VDD compared to their male counterparts (39%). According to the results of this study, there is a clear relation between severe vitamin D deficiency and incidence of type 2 diabetes mellitus, whereas, mild and moderate VDD showed no difference from normal.

Biography:

Abstract:

Context: Warfarin and similar vitamin-K antagonists have been the standard therapy for patients with a metallic valve or bioprosthesis with atrial fibrillation. Even with the appropriate use of therapy, there is a high incidence of thromboembolic events: 1-4% per year. Furthermore, bleeding risk is significant ranging from 2% to 9% per year. Objective: To examine the effect of dabigatran etexilate versus dose-adjusted warfarin for the prevention of intra-cardiac thrombus in persistent or permanent atrial fibrillation (AF) after at least 3 months after aortic and/or mitral bioprosthesis replacement. Design, Setting and Participants: DAWA is a phase-2, prospective, open-label, randomized, pilot trial designed to compare 110 mg twice-daily oral dabigatran etexilate with dose-adjusted warfarin for the prevention of stroke (ischemic or hemorrhagic) and systemic embolism in persistent or permanent atrial fibrillation after bioprosthesis replacement (through research of intra-cardiac thrombus). From August 2013 to April 2015, 100 patients at least 3 months after aortic and/or mitral bioprosthesis replacement and AF postoperatively, who match eligibility criteria will be selected from Ana Nery Hospital in Salvador-Bahia with follow-up of three months.