Statistical Implementation of the Diabetes Guidance for Cardiovascular Outcomes
*David Hoberman, Food and Drug Administration Keywords: diabetes, cardiovascular, statistics The 2008 FDA/CDER diabetes cardiovascular outcomes guidance provides very general advice to sponsors when designing a program to assess cardiovascular risk. As a result, it has generated a wealth of protocols which present statistical challanges including meta-analyses with sparse data, heterogeneous sources of data, sequential analyses and adaptive designs, all in the context of evaluating two null hypotheses. Some protocols combine some of the above features; others nearly all. This talk will briefly summarize reviewers' experience with the expectation that questions and answers following the talk will help clarify the issues confronting the FDA's review of cardiovascular outcome submissions for drugs to treat type 2 diabetes.
|
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