[Open letter to US FDA and NIH]
peter.suber's bookmarks 2023-01-30
Summary:
"I write regarding concerns about the lack of compliance by medical product sponsors with requirements to report certain clinical trial results information to the ClinicalTrials.gov database. The law requires that certain clinical trial sponsors report results to ClinicalTrials.gov to expand the knowledge base, support additional research, and provide important safety and efficacy information to health care providers and researchers. These important goals depend on adequate compliance with applicable requirements and appropriate enforcement."