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Editor's Note
February 2016

Making Data Submitted to the Food and Drug Administration More Visible

JAMA Intern Med. 2016;176(2):259. doi:10.1001/jamainternmed.2015.6773

The visibility of clinical research and its underlying data has grown through efforts such as the National Library of Medicine’s online trial registry, ClinicalTrials.gov, along with data-sharing initiatives, such as the Yale Open Data Access Project (in which I am involved). While the Food and Drug Administration (FDA) has similarly enhanced clinical research visibility by making FDA-prepared documents more widely available, much important material, including clinical trial data, is considered confidential information or trade secrets.1 A Research Letter in this issue of JAMA Internal Medicine illustrates how this potentially limits our understanding of the research supporting therapies regulated by the FDA.2 Marciniak and colleagues examined participant loss–to–follow-up rates for major trials of oral antithrombotic therapies, comparing the rates reported in medical journal publications with the rates independently estimated by Marciniak using data submitted by manufacturers to the FDA as part of an analysis investigating the cancer risk associated with these therapies that was performed when he was an FDA medical officer. Their analysis demonstrated substantial discrepancies between the published and the independently estimated loss–to–follow-up rates. While this research has implications for any interpretation of antithrombotics’ therapeutic efficacy and safety, it also demonstrates the need for greater data visibility and the importance of making all clinical trial data submitted to the FDA widely available, including to external researchers for independent scrutiny. As recently explained by the Institute of Medicine, “Patients and their physicians depend on clinical trials for reliable evidence on what therapies are effective and safe. Responsible sharing of the data gleaned from clinical trials will increase the validity and extent of this evidence.”3(pix)

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Conflict of Interest Disclosures: Dr Ross receives research grant funding through Yale University from the US Food and Drug Administration to develop methods for postmarket medical device surveillance and from Medtronic, Inc, and Johnson and Johnson to support the Yale University Open Data Access (YODA) Project to develop methods for clinical trial data sharing. No other disclosures are reported.

References
1.
Kesselheim  AS, Mello  MM.  Confidentiality laws and secrecy in medical research: improving public access to data on drug safety .  Health Aff (Millwood). 2007;26(2):483-491.PubMedArticle
2.
Marciniak  TA, Cherepanov  V, Golukhova  E,  et al.  Drug discontinuation and follow-up rates in oral antithrombotic trials [published online January 11, 2016].  JAMA Intern Med. doi:10.1001/jamainternmed.2015.6769.
3.
Institute of Medicine.  Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: National Academies Press; 2015.
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