Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States
Compose Response

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Author Information
First or given name, e.g. 'Peter'.
Your last, or family, name, e.g. 'MacMoody'.
Your email address, e.g.
Your role and/or occupation, e.g. 'Orthopedic Surgeon'.
Your organization or institution (if applicable), e.g. 'Royal Free Hospital'.
Statement of Competing Interests


  • Responses are moderated before posting and publication is at the absolute discretion of BMJ, however they are not peer-reviewed
  • Once published, you will not have the right to remove or edit your response. Removal or editing of responses is at BMJ's absolute discretion
  • If patients could recognise themselves, or anyone else could recognise a patient from your description, please obtain the patient's written consent to publication and send them to the editorial office before submitting your response [Patient consent forms]
  • By submitting this response you are agreeing to our full [Response terms and requirements]

Vertical Tabs

Other responses

Jump to comment:

  • 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....

    Show More
    Conflict of Interest:
    None declared.