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April 23, 2020

Increasing Access to FDA Inspection Reports on Irregularities and Misconduct in Clinical Trials

Author Affiliations
  • 1Epidemiology Unit, Health Research Institute─Fundación Jimenez Díaz, University Hospital, Universidad Autónoma de Madrid, Madrid, Spain
  • 2Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  • 3Computational Health Informatics Program (CHIP), Boston Children’s Hospital, Boston, Massachusetts
  • 4Department of Pediatrics, Harvard Medical School, Boston, Massachusetts
JAMA. 2020;323(19):1903-1904. doi:10.1001/jama.2020.1631

Transparency related to clinical trial protocols and data has become the expected standard over the past 2 decades, with broad support from patients, the scientific community, and regulatory agencies. Requirements for trial disclosures are codified in US statute and, since 2017, regulation requires timely submission of trial results to ClinicalTrials.gov. However, meaningful clinical trial transparency extends beyond prospective registration and reporting results. The public, for example, must know whether trials were conducted according to international standards for research integrity and must have access to reports investigating departures from good clinical practice guidelines.

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    1 Comment for this article
    EXPAND ALL
    Remedying Information Asymmetries in the Clinical Trial Process
    Marlowe Fox, JD, MS | N/A
    Among the race to publish the latest medical study, or merely parse through them all—this very practical article explores information barriers. Information barriers present nonlinear risk: We could know 99 percent about a particular study—but one percent could completely undermine its validity. Even published and seemingly well-meaning trials are subject to biases, from case control to variable selection. P-values regarding the use of HCQ—whether in support of it (1) or against it (2)—seem convincing, but also show evidence of potential p-hacking. At least to some degree, these biases can be inferred through scientific and rational scrutiny. However, other forms of subterfuge, by their very nature, will not be discernible even through the peer-review process. The FDA has fewer information barriers and can provide close to real-time information regarding unfair and deceptive practices. However, they do not seem willing to provide this information. If at all, it is only through freedom of information act requests that are heavily redacted. Unfortunately, this is likely due in part to some sort of regulatory capture. As such, a special Inspector General (or some sort of equivalent) should be set up to monitor the clinical trials and report information back to the general public. (Of course, this is not a panacea. One need only look back to the Special Inspector General of the Troubled Assets Relief Program (TARP)).

    There is an extremely large carrot at the end of the efficacious therapy stick. This will create an incentive for companies to game their clinical trials and manipulate data whether it is to hide potential side effects or generate statistically significant correlations. To say nothing of the chaotic and fear-induced atmosphere we are all currently amid, which will likely give these companies a get-out-of-jail-free card for any chicanery. Again, this is similar to the foreclosure crisis, where major banks took TARP money to modify foreclosures—but, systematically, refused to do so. They received infinitesimal financial penalties after the fact that were completely insufficient to offset the benefit had by their strategic behavior.

    Ironically, this may be one of the most important articles out there. At least, it gives a broader readership the idea that we don’t know what we don’t know.

    References:

    1. Efficacy of hydroxychloroquine in patients with COVID-19: results of a randomized clinical trial. Zhaowei Chen, Jijia Hu, Zongwei Zhang, Shan Jiang, Shoumeng Han, Dandan Yan, Ruhong Zhuang, Ben Hu, Zhan Zhang. medRxiv 2020.03.22.20040758; doi: https://doi.org/10.1101/2020.03.22.20040758.

    2. Outcomes of hydroxychloroquine usage in United States veterans hospitalized with Covid-19. Joseph Magagnoli, Siddharth Narendran, Felipe Pereira, Tammy Cummings, James W Hardin, S Scott Sutton, Jayakrishna Ambati. medRxiv 2020.04.16.20065920; doi: https://doi.org/10.1101/2020.04.16.20065920
    CONFLICT OF INTEREST: None Reported
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