Table 2.

Current thinking on IND safety reporting of PRO symptomatic AE results in oncology clinical trials

Topic of concernCurrent thinking
Do PRO measures of symptomatic AEs in cancer clinical trials require IND safety reporting?
  • For FDA purposes, IND safety reporting is currently based on clinical evaluation and standard clinician-reported outcome (ClinRo) CTCAE data.

  • There is no U.S. regulatory requirement that PRO data be directly reported as safety events to the FDA.