TL49: Challenges in the Designs of Non-Inferiority and Equivalence Trials with Clinical Endpoints
*Madhuja Mallick, Forest Laboratories Inc.
In clinical trials, a placebo-controlled trial is common to demonstrate medical efficacy and safety/tolerability of the treatment of interest. However to demonstrate the treatment of interest is not worse than the already marketed treatment in the disease area, a non-inferiority trial can be appropriate. On the other hand, to demonstrate the similarity of the study treatment with other existing (already marketed) treatment, equivalence trials with clinical endpoints can be of interest. Challenges exist in selecting the non-inferiority or equivalence margin, in making the assumptions for variability estimate, in selecting the population, in the analyses, and in the interpretations of study results. This discussion will try to focus on some of these challenges and current statistical practices to handle those.
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
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC