An Open Letter in Support of FDA’s Clinical Study Report Pilot Project

In January 2018, the US Food and Drug Administration announced a pilot project designed to enhance transparency around drug approval by publicly disclosing a sample of Clinical Study Reports (CSRs). The pilot project would be an important step forward by the FDA, marking a renewal of interest in the FDA’s longstanding authority to disclose certain regulatory data that is generally not publicly available. Despite the value of disclosing CSRs, a year after its launch, the pilot project appears to have stalled. Only a single CSR has been posted on FDA’s website. 
Today, CSPI, along with other academic signatories, marked the anniversary of the FDA announcement by writing to the FDA urging it to not only see the Pilot Project through to completion, but to make public disclosure of CSRs mandatory. The signatories undertook to use CSRs in the following ways for the purpose of improving public health:

  1. to learn more about safety and efficacy evidence supporting FDA’s approval decisions;
  2. to include additional data from CSRs in systematic reviews along with other regulatory data;
  3. to conduct methodological research to better characterize how to use CSRs in evidence synthesis;
  4. to ensure the reports of trials in the biomedical literature (the building blocks for the majority of systematic reviews and clinical practice guidelines) are reported fully and accurately, with mechanisms available for public access to underlying data.

Although not part of the letter, CSPI remains concerned about the FDA’s failure to take any public action with respect to the release of Complete Response Letters (CRLs), the letters issued to companies when their applications for marketing are not accepted.  In 2015, CSPI President Peter Lurie, then at FDA and leading the Agency’s Transparency Initiative, published an article in the BMJ documenting how little information contained in CRLs was ultimately made public.

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