A regulatory perspective on multiplicity issues in clinical trials
View Presentation View Presentation
*Mohammad F Huque, FDA 

Keywords: multiplicity, guidance, false posite error rate

A clinical study is usually designed with multiple objectives, requiring evaluation of treatment effects on multiple endpoints. The possibility for alternative paths of winning raises “multiplicity issues”, as it can inflate the error rate of making false positive conclusions, unless this error rate is controlled by a prospectively planned statistical test strategy appropriate for the trial design. The last decade has witnessed a surge of research in the development of principles and methods for addressing multiplicity issues of clinical trials for improving their scientific credibility and success. Therefore, on recognizing the importance of this topic, the FDA has been working on a draft guidance for applications of these principles and methods appropriate for regulatory applications. This presentation will discuss in general terms progress made in draft guidance as well some scientific research findings aimed for addressing multiplicity issues in clinical trials.