The US FDA is enhancing its clinical trial transparency policy

The FDA announces today (January 16, 2018) that

  • Starting from January 2018, clinical study reports (CSRs) and other information of pivotal clinical trials of some of the recently approved drugs will become available to the public on its new website.
  • The identifier numbers (NCT#) of clinical trials will be linked to drug application materials that the FDA uses for drug approval

Regarding its Clinical Data Summary Pilot Program, the FDA clarifies that

  • Only portions of the CSR (eg, summary of clinical evidence) will be posted on its website;
  • The protocol and amendments and the statistical analysis plan for each study will also be posted; but
  • Raw data will not be posted.


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