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Comment & Response |

Study Design and the Drug Development Process—Reply

John P. A. Ioannidis, MD, DSc1; Iztok Hozo, PhD2; Benjamin Djulbegovic, MD, PhD3
[+] 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.
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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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May 21, 2014
Robert Goldberg, PhD; Stuart Kauffman, MD, PhD; Eric J. Topol, MD
1Center for Medicine in the Public Interest, Springfield, New Jersey
2Institute for Systems Biology, Seattle, Washington
3The Scripps Research Institute, La Jolla, California
JAMA. 2014;311(19):2023. doi:10.1001/jama.2014.3826.
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