This was quite eye opening.
Research Misconduct Identified by the US Food and Drug Administration
http://archinte.jamanetwork.com/article.aspx?articleid=2109855#Conclusions
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Research Misconduct Identified by the US Food and Drug Administration
The findings presented in this study should give us pause. This investigation has found numerous studies for which the FDA determined there was significant evidence of fraudulent or otherwise problematic data. Such issues raise questions about the integrity of a clinical trial, and mention of these problems is missing from the relevant peer-reviewed literature. The FDA does not typically notify journals when a site participating in a published clinical trial receives an OAI inspection, nor does it generally make any announcement intended to alert the public about the research misconduct that it finds. The documents the agency discloses tend to be heavily redacted. As a result, it is usually very difficult, or even impossible, to determine which published clinical trials are implicated by the FDA’s allegations of research misconduct.
The FDA has legal as well as ethical responsibilities regarding the scientific misconduct it finds during its inspections. When the agency withholds the identity of a clinical trial affected by scientific misconduct, it does so because it considers the identity to be confidential commercial information, which it feels bound to protect.184 However, failing to notify the medical or scientific communities about allegations of serious research misconduct in clinical trials is incompatible with the FDA’s mission to protect the public health. Such allegations are relevant to include in the peer-reviewed literature on which physicians and other medical researchers rely to help them choose treatments that they offer to patients and other research participants.
To better serve the public health, the FDA should make unredacted information about its findings of research misconduct more readily available. The agency should make sure that any substantial evidence of misconduct is available to editors and readers of the scientific literature. One possible mechanism for this would be to use the national clinical trials database: any OAI inspection affecting a trial site should be promptly noted at http://www.clinicaltrials.gov. The FDA should also create a website or a publicly available database that lists all OAI-rated inspections of clinical sites and provides links to copies of the relevant, unredacted, inspection-related documents
http://archinte.jamanetwork.com/article.aspx?articleid=2109855#Conclusions
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