Newly Launched FDA Pilot Program Includes Data Sharing

A new FDA pilot program, which allows clinical study result information to be posted on their website, has some worried that an agency who once resisted sharing data and left open source activities to the companies that developed the data, will create more challenges than benefits. Advocates, on the other hand, suggest that boosting transparency of clinical data will allow stakeholders to access and understand information that it used in approving a new drug and this will enhance innovation and help get life-saving drugs to market faster.

The pilot is planned to launch in January 2018 and will include posting clinical trial study reports (CSRs), company-generated summaries of clinical trial results, of up to nine new drug applications across a range of diseases submitted by voluntary sponsors.  Once completed, the FDA will seek feedback and allow for public comments on the program.

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Potential Advantage

  1. Clinical trial result transparency may benefit patients, trial participants and the research community by communicating valuable information that could potential save a life.
  2. It will help organizations learn from other sponsor experiences – good and bad – to develop protocols/processes that may help get their application approved, and bypass redaction.
  3. Companies may take more care in how they prepare the CSR and any associated protocols on the first pass through the FDA, cutting down on time and resources needed to get applications approved.

 

Potential Disadvantages

  1. If the program is successful, this may be mean that all future CSRs will need to be prepared for disclosure, which will require more work to anonymizing sensitive personal data.
  2. Any individual patient data that is disclosed could compromise the privacy rights of an individual.
  3. Until the program is launched, we don’t really understand all the potential problems so the unknown can be daunting.
 

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