TL59: Design and Analysis of Non-Interventional/ Observational Clinical Trials
*Shankar Srinivasan, Merck 


Non-interventional trials are studies without an overt therapeutic intervention and are becoming increasingly popular due to operational efficiencies. These studies are to be conducted under restrictive constraints which can limit their scientific utility. It is however difficult to ethically justify interventional trials especially those involving placebo or inferior comparators in a post-marketing setting where efficacy has already been established. In such settings regulators are increasingly finding non-interventional trials acceptable when additional safety and efficacy data are required. Pros and cons, features of non-interventional trials and a brief overview of analysis methods will be presented before opening the discussion to attendees at the round table