Contributing to proposed Rule for Results Reporting of Clinical Trial Data

Comments submitted to NIH

In March, we submitted public comments to the National Institutes of Health in response to the Proposed Rule for Clinical Trial Registration and Results Submission. Our comments addressed the need for:

  • Providing non-technical summaries that follow health literacy principles and use non-promotional language so that they benefit trial participants and their families
  • Extending and coordinating results submission deadlines
  • Adopting standard data formats across agencies
  • Mandatory expanded access reporting, and
  • Extending the timeframe for submitting corrections of clinical trial information.

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