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Comment & Response
May 21, 2014

Study Design and the Drug Development Process—Reply

Author Affiliations
  • 1Stanford Prevention Research Center, Stanford University, Stanford, California
  • 2Department of Mathematics, Indiana University, Gary
  • 3Division of Evidence-based Medicine, University of South Florida, Tampa
JAMA. 2014;311(19):2023-2024. doi:10.1001/jama.2014.3829

In Reply We share the enthusiasm expressed by Dr Goldberg and colleagues for advances in genomics, but we disagree with their dismissal of RCTs, a design that has served medicine so well. There is no empirical evidence that -omics allow absolute predictability of treatment effects and outperform treatment discovery in RCTs. Goldberg and colleagues succumb to the gambler’s fallacy (ie, the belief that the effects of treatments can be inferred in unique cases without reference to a reference [class] set), which was refuted convincingly by Bradford Hill more than 60 years ago.

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