Citation: Turner E (2005) Correction/Clarification about FDA Review Documents. PLoS Med 2(12): e422. https://doi.org/10.1371/journal.pmed.0020422
Published: December 27, 2005
Copyright: © 2005 Erick Turner. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Competing interests: ET is author of the PLoS Medicine Essay cited in this Editorial and discussed in the present response. Also, ET is a former reviewer (medical officer) with the FDA.
Emma Veitch cites my PLoS Medicine Essay  about how the Food and Drug Administration's (FDA's) review of documents can serve as a source of clinical trials data, but she follows it up with the statement, “However, it is difficult to have confidence in data released by sponsors when the data have not been subjected to external, independent peer review. Furthermore, this information is not integrated with other data, or indexed” .
While I agree with the second assertion, the first assertion—that the data are not subjected to external, independent peer review—is off the mark. FDA reviews are indeed external and independent to the sponsor. These reviews are conducted not by the sponsors but by physicians and scientists employed by the United States government. True, the data originate with the sponsor. However, once the sponsor submits data to the FDA, a level of rigor and scrutiny is applied to them that is arguably higher than what occurs in the typical journal manuscript review process.
First, FDA reviewers typically revisit the original protocol submitted before the study was conducted in order to verify that the sponsor has not engaged in hypothesizing after the results are known (“HARKing”) . By contrast, journal reviewers typically do not have access to the original protocol. As a result, they must trust that HARKing has not occurred, a dubious assumption in view of recent data .
Second, FDA statistical reviewers obtain the raw data from the sponsor, and determine whether the sponsor's findings can be replicated. By contrast, journal reviewers typically have access to only the summary statistics reported (perhaps selectively) to them by the authors or the sponsors. Consequently, reviewers can only speculate whether they could replicate the findings.
As a result, I believe that the FDA review process warrants a higher level of confidence than the conventional journal manuscript review process.
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