PPT-COUNTRY EXPERIENCE ON CLINICAL TRIALS OVERSIGHT AND ETHICAL CLEARANCE IN GHANA

Science and Politics The Case of The Ebola Clinical Trials in Ghana Ama Edwin   MB  ChB MPhil Psych DBioethics Overview Ghanas Role in the Ebola Vaccine Clinical . Cynthia M. Otto, DVM, PhD DACVECC. Associate Professor of Critical Care. What is a clinical trial?. A prospective evaluation in which the factor of interest is controlled by the investigator. RANDOMIZATION. Science . and . Politics. : . The . Case of The Ebola Clinical Trials . in . Ghana. Ama. . Edwin.  . MB.  ChB; MPhil (Psych); . D.Bioethics. Overview. . Ghana’s Role in the Ebola . Vaccine Clinical . Ancient Ghana was located about 400 miles northwest of the modern day country of the same name.  When the modern country of Ghana won their independence, they took the name of a famous (and nearby) ancient kingdom - the kingdom of Ghana.. Susan S. . Ellenberg. , Ph.D.. University of Pennsylvania. SCT/ICTMC Joint Meeting. Liverpool, UK. May 8, 2017. CLINICAL TRIALS TIMELINE. 1948: First randomized clinical trials of modern era. 1962: Amendments to U.S. Food, Drug and Cosmetic Act requiring demonstration of efficacy as well as safety. 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 . Virginia A. Caine, M.D.. Associate Professor of Medicine. Division of Infectious Diseases. Indiana University School of Medicine. Director, Marion County Public Health Department. Indianapolis, Indiana. University of Ghana http://ugspace.ug.edu.gh 107 University of Ghana http://ugspace.ug.edu.gh 106 University of Ghana http://ugspace.ug.edu.gh 105 University of Ghana http://ugspace.ug.edu.gh A country clearance is a mandatory memorandum used to request and authorize official international travel to a particular country. An approved country clearance must be in place before travel can happ Ashley E. Ross MD PhD. Executive Medical Director. Mary Crowley Cancer Research Centers. NASPCC Annual Meeting 2019. Objectives. Define GCP (Good Clinical Practice) and its applications for patients and 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.. Professor Julia . Brown. Leeds Institute of Clinical Trials Research, University of Leeds. Introduction. First clinical trial in 1747, James Lind. Clinical trials are gold standard for the evaluation of new treatments/interventions in health care . of. human . challenge trials. Nele Berthels. FAMHP Vaccine Symposium. , . BRUSSELS, . 9 September 2017. Disclaimer. This presentation . reflects . my . personal point of . view, . and . not necessarily the . Helen Hill. Senior Regional Advisor Clinical Trials . hhill. @liv.ac.uk. www.ctrc.org.uk. . Specialist. . units . to . design, conduct, analyse and publish clinical trials and other well-designed studies. . Covered in this presentation. Basic information about clinical trials. Information about finding a clinical trial. Information about participating in or leaving a clinical trial . Vision. Mission. Make Ontario a preferred location for global clinical trials, while maintaining the highest ethical standards..