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Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States
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  • Published on:
    Letter in response: Clinical Trial Transparency: A re-assessment of industry compliance with clinical trial registration and reporting requirements in the United States
    • Jennifer E. Miller, PhD NYU School of Medicine, New York, NY
    • Other Contributors:
      • Michelle M. Mello, JD
      • David Korn, MD
      • Joseph S. Ross, MD, MHS

    Dear Editors,

    Thank you for the opportunity to respond to Lassman et al.’s re-analysis of our study titled, “Clinical trial registration, reporting, publication and FDAAA Compliance: A cross-sectional analysis and ranking of new drugs approved by the FDA in 2012”.1 Our original study assessed the clinical trial transparency of novel drugs approved by the FDA in 2012 that were sponsored by large drug companies. We assessed the drugs by two sets of transparency standards: U.S. legal requirements and an ethical standard that all human subjects research should be publicly accessible to contribute to generalizable knowledge.

    Our original analysis included a review of 15 drugs, sponsored by 10 large companies, involving 342 trials. Lassman and colleagues’ reassessment examined 69 of these 342 trials and focused on only the U.S. legal requirements standard. Lassman et al did not elaborate on why they limited their assessment to this subset of trials and on compliance with legal requirements. As a reminder, US clinical trial disclosure requirements are defined by the Food and Drug Administration Amendments Act (FDAAA), passed in 2007.2

    We applaud efforts to replicate studies. We are glad that our policy of publicly sharing data through the Dryad Digital Repository enabled replication and re-analysis.3 Additionally, we generally agree with the Lassman and colleagues re-assessment of our study using today’s new and updated knowledge base and world-view....

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    Conflict of Interest:
    None declared.