Multiplicity in confirmatory clinical trials: a case study with discussion from a JSM panel.

Statistics in medicine

PubMedID: 26112381

Wang SJ, Bretz F, Dmitrienko A, Hsu J, Hung HM, Koch G, Maurer W, Offen W, O'Neill R. Multiplicity in confirmatory clinical trials: a case study with discussion from a JSM panel. Stat Med. 2015;.
An invited panel session was conducted in the 2012 Joint Statistical Meetings, San Diego, California, USA, to stimulate the discussion on multiplicity issues in confirmatory clinical trials for drug development. A total of 11 expert panel members were invited and 9 participated. Prior to the session, a case study was previously provided to the panel members to facilitate the discussion, focusing on the key components of the study design and multiplicity. The Phase 3 development program for this new experimental treatment was based on a single randomized controlled trial alone. Each panelist was asked to clarify if he or she responded as if he or she were a pharmaceutical drug sponsor, an academic panelist or a health regulatory scientist. Copyright © 2015 John Wiley & Sons, Ltd.