PPT-CLINICAL TRIALS IN THE TWENTY-FIRST CENTURY: ONGOING CHALLENGES AND EMERGING ISSUES

Susan S Ellenberg PhD University of Pennsylvania SCTICTMC Joint Meeting Liverpool UK May 8 2017 CLINICAL TRIALS TIMELINE 1948 First randomized clinical trials of modern era 1962 Amendments to US Food Drug and Cosmetic Act requiring demonstration of efficacy as well as safety. and the Twenty-first Century. Chelsea Bell. Southern Methodist University. MSA 3325. Spring 2013. 1980-2013. Historical. Background. the 1980s. 1980 . Ronald Reagan elected president. 1981 . Lady Diana Spencer marries Prince Charles. 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. Important Terms. Emerging . infectious disease- . An infectious disease that has newly appeared in a population or that has been known for some time but is rapidly increasing in incidence or geographic range. Elaine M Pascoe, Darsy Darssan, Liza A Vergara. Australasian Kidney Trials Network. The University of Queensland. . Overview. Covariate adaptive randomization. Minimization example. Minimization issues. Airworthiness. Emerging issues in Airworthiness. - digital. 60 digital years. Digital Airworthiness . Digital Mobility. Rulemaking in Europe. Global Standards. Key Points . Next Challenges. Emerging issues in Airworthiness. Towards EDCTP2. 22 July 2014. Melbourne, Australia. Ole F. Olesen, Ph.D., HD. Director of North-North Cooperation,. EDCTP, The Netherlands. Justification for EDCTP2. Objectives. C. linical . development of effective, safe, accessible, suitable and affordable medical interventions for poverty related and neglected . 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.. Zoonoses. . Emerging Zoonoses. . According to the WHO emerging . zoonoses. is "a . zoonosis. that is . newly recognized . or . newly evolved. , or that has occurred previously but shows an increase in incidence or expansion in geographical, host or vector range”. 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 . This webinar is being recorded and will be posted to the CTTI website. All participants are muted upon entry. Questions can be entered in the chat box during the webinar . Questions will be . addressed after . Leanne Madre, CTTI . Cindy Geoghegan, Individual Patient Representative . Virginia . Nido. , Genentech, a Member of the Roche Group. February 21, 2019. Disclaimer. The views and opinions expressed in this presentation are those of the individual presenter and do not necessarily reflect the views of the Clinical Trials Transformation Initiative. Compensation in clinical trials can mean two distinct things:. w. hen . participants receive monetary or . other benefits.  for their participation in the clinical trial; . or. w. hen participants . 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.. Why it Matters, How it Affects Power and How to Generate a Randomization List. Brian . Ronayne. Research Statistician. nQuery. Webinar. Host. Agenda. Randomization in Clinical Trials. Common Randomization Strategies.