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History of the Clinical Trials Transparency and Disclosure Landscape





Description

This session covers the benefits of public access to clinical trial information, issues surrounding the publication and transparency of clinical trial information and the impact of those issues, and key clinical trial reporting requirements.

To learn more about the topics in this video, visit these resources:

  • Clinical Trials: Read about the ICMJE policies on clinical trial registration and data sharing statement requirements for journal submissions. (Source: ICMJE)
    • ICMJE clinical trial registration and data sharing statement policies:
      • To promote the ethical obligation to responsibly share trial data
      • ClinicalTrials.gov: IPD Sharing Statement data element
      • Condition for publication of trial results (effective 2018)
  • Section 801 of the Food and Drug Administration Amendments Act of 2007: Read the official publication of FDAAA 801. (Source: U.S. Government Publishing Office)
  • 42 CFR Part 11: Read the Final Rule for Clinical Trials Registration and Results Information Submission. (Source: Electronic Code of Federal Regulations)
  • NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information: Read the NIH policy that establishes the expectation that all investigators conducting clinical trials funded in whole or in part by NIH will ensure that these trials are registered on ClinicalTrials.gov and that results information for these trials is submitted to ClinicalTrials.gov. (Source: FederalRegister.gov)

Other Selected Reporting Requirements:

Last Reviewed: September 10, 2021