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How Science reported on FDA’s oversight of clinical research

This story was supported by the Science Fund for Investigative ReportingPlease help Science pursue ambitious journalism projects.

Science collected all publicly available data from the beginning of former President Barack Obama’s time in office through the first 3 years of President Donald Trump’s tenure on the following Food and Drug Administration (FDA) enforcement and compliance actions related to clinical trials and the institutional review boards (IRBs) that oversee them:

  • inspection reports designated “official action indicated” (OAI),
  • inspection reports designated “voluntary action indicated”,
  • inspection reports designated “no action indicated”,
  • warning letters, which sometimes follow OAI inspections,
  • closeout letters, which sometimes follow warning letters and indicate that problems were corrected,
  • disqualifications, which designate researchers barred from conducting trials, and
  • untitled letters (rarely publicly posted), which sometimes follow OAI inspections and represent an intermediary step below a warning letter.

The federal Freedom of Information Act (FOIA) was used extensively to obtain additional nonpublic records. Some FOIA requests were made on behalf of Science by FDAzilla, a commercial service that tracks federal government actions.

The data sources also included, but were not limited to, the following:

Meagan Weiland assisted on the reporting for this investigation.