Regulatory Considerations for Addressing Multiplicity Problems of Clinical Trials with Multiple Endpoints

• Activity Number: 645
• Type: Invited
• Date/Time: Thursday, August 5, 2010 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Mohammad F. Huque*+
• Companies: FDA
• Keywords: multiplicity ; multiple endpoints ; clinical trials

Abstract

Confirmatory trials with multiple endpoints can raise multiplicity issues which might impact Type I error. Statistical approaches such as gatekeeping and tree-structured strategies are now available that can solve variety of multiplicity problems for multiple endpoints. However, applications of these approaches in the regulatory setting are often not straightforward as appropriate design and analysis should take into account the peculiarities of different diseases. Therefore, a regulatory guidance is needed. Such guidance would elaborate on basic multiplicity concepts and considerations that can be helpful in making sound regulatory decisions, and are useful in planning of trials and interpretation of results, and also in labeling and promotion of new beneficial treatments. This presentation will provide a list of key topics that can be included in such guidance with some discussions.