RL14 Sample Size Re-estimation: Pros and Cons
*Shiling Ruan, U.S. Food and Drug Administration Keywords: Many pivotal study protocols propose sample size re-estimation (SSR) during the midcourse of a clinical trial. Two strong motivations are usually cited in the literature: first, the original sample size is often estimated based on insufficient or inaccurate information; second, the sample size estimate based on a clinically meaningful treatment effect is often overpowered, which implies an unnecessary large sample size and a waste of resources. There are mainly two types of SSR approaches. Some proposed adjustment upward only by updating a nuisance parameter to ensure sufficient power. Others have proposed SSR based on the interim finding of the treatment effect size rather than the nuisance parameters. In this round table discussion, the pro and cons of SSR approaches and the challenges to FDA reviewers will be discussed.
|
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