FDA draft guidance on adaptive design clinical trials: Pfizer's perspective.
The Food and Drug Administration of the United States issued a draft guidance on adaptive design clinical trials in February 2010. This draft guidance has attracted a lot of attention because of the increasing interest in adaptive trials by the pharmaceutical industry in recent years. In this paper, we report on highlights of comments collected within Pfizer on this draft guidance. In addition, we share Pfizer's internal journey to promote efficient trial designs since 2005. Adaptive designs have been part of that journey.
Statistics, Pfizer, Inc., Kalamazoo, Michigan, USA. Christy.j.chuang-stein@pfizer.com
Christy
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Chuang-Stein
Mohan
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Beltangady
D015982:Bias; D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D017277:Drug Approval / Q000379:methods*; D004345:Drug Industry; D017408:Guidelines as Topic; D006801:Humans; D015233:Models, Statistical; D015203:Reproducibility of Results; D012107:Research Design; D016896:Treatment Outcome; D014481:United States