TL59: Design and Analysis of Non-Interventional/ Observational Clinical Trials
*Shankar Srinivasan, Merck Keywords: 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
|
Key Dates
-
April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC