PPT-Ethics of alternative clinical trial methods in LMIC research: The GHIS experience

Dr Gibril Ndow Imperial College London MRC Unit The Gambia Gambia Hepatitis Intervention Study GHIS Start July 1986 High burden of liver cancer Mostly attributable to HBV infection Most HBV infections acquired early childhood. ethics . Jan Deckers. School of Medical Education. 1. Objectives. To reflect. on what ethics is.. To develop. your skills as an ethical researcher.. To prepare yourself to apply for ethical approval from research ethics committees.. Research Ethics: theory. Jan . Deckers. School of Medical Education. 1. Objectives. To reflect. on what ethics is.. To develop. your skills as an ethical researcher.. To prepare yourself to apply for ethical approval from research ethics committees.. . Ethics and Writing your Proposal. Research Question. Literature Review. Research Design. Present. Write Report. Data Analysis. Data Collection. 2. Ethics. 3. Research ethics . relates . to . Name. Institutional Affiliation. In modern society, drug companies face challenges in conducting new clinical . trials (. Biehl. , 2006. ).. The amount of drugs entering global market has reduced. . Cost of clinical trials have escalated, R&D productivity . Trial . Office:. S. upport . service for clinical trials . performed . using BMC clinical infrastructure. A . new . clinical research support service is being launched to . provide a central . and comprehensive framework . Christopher S. Coffey. Professor, Department of Biostatistics. Director, Clinical Trials Statistical and Data Management Center. University of Iowa. May 28, 2019. In this webinar, we will:. Discuss the importance of adequate study planning for small clinical trials. . Primary Instructor: . Elizabeth Garrett-Mayer, PhD. Professor of Biostatistics, Dept. of Public Health Sciences. Director of Biostatistics, Hollings Cancer Center. Context: K-12 award. Paul . Calabresi. Dr Sunil S Vernekar . MD, . Dipl. Epidemiology. Associate Professor, . Dept. of Physiology, . Senior Research Officer, Women’s & Children’s Health Research Unit,. KAHER’s J N Medical College, . and Animal Research: An Overview . Dr.M.K.Sudarshan, MD (BHU), FAMS, Hon.FFPH (UK). Chairman . Ethics committees of Fortis Hospitals and Public Health Foundation of India , Bangalore . Member . RGUHS committee on advanced and collaborative research. Dr. Haider Raheem Mohammad. Research ethics and clinical trials . in therapeutic . research. All medicines employed in pharmacy are subjected to two linked phases of activity: discovery and validation. Some botanical species like the opium poppy were discovered by chance to have medicinal value some 2000 or more years ago and validated by simple trial and error. The vast majority of the more potent and selective drugs used in the UK today have been subjected to systematic processes of discovery, evaluation, testing and approval. Since the introduction of voluntary assessment by the Committee on Safety of Drugs in the UK in 1964, formal regulatory approval of all medicines has become rigorous and mandatory.. Best Practices and Enhanced Standards for Research. “International norms, standards, and guidelines … are required to govern, manage and improve the quality of research; address inefficiencies…; promote transparency (related to planned, ongoing, . “Putting it All Together. ”. 1. Why the changes to NIH-funded studies involving human subjects?. No policies existed to make sure that the public had access to results from unpublished NIH-funded research . PERFUSE Medical Research &. Clinical Trial Course. Clara Fitzgerald, MPH. The Importance of Clinical Trial Protocols. The Clinical Trial Protocol is the complete written description of, and scientific rational for clinical research studies. A Feasibility Study. SciSIP. PI Conference, September 2012. Ernst R. Berndt. Iain M. Cockburn. MIT, Boston University, and . National Bureau of Economic Research. What?. Analysis of trends in costs of doing clinical trials.