Evaluating Cardiovascular Risk in Diabetes Clinical Trials: An FDA Statistician's Perspective

• Activity Number: 328
• Type: Topic Contributed
• Date/Time: Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Jon Todd Sahlroot*+
• Companies: FDA
• Keywords: meta-analysis ; cardiovascular risk ; diabetes ; clinical trial

Abstract

In December, 2008, The U.S. Food and Drug Administration (FDA) issued the Final Guidance for Industry "Diabetes Mellitus - Evaluating Cardiovascular Risk in New Anti-diabetic Therapies to Treat Type 2 Diabetes". The Guidance asks sponsors to demonstrate that new therapies for treating type 2 diabetes are not associated with unacceptable levels of cardiovascular (CV) risk. Sponsors are asked to pre-specify statistical methods to evaluate CV risk across controlled trials in the pre-approval development program and, if necessary, post-approval. The statistical recommendations are very general and allow for flexibility in approaches. I will discuss the range of statistical plans submitted to FDA in response to the Guidance and comment on issues such as multiple testing, power calculations and prospective planning of meta-analyses.