Use of PRO measures to inform tolerability in oncology trials: Implications for clinical review, IND safety reporting and clinical site inspections

Cancer therapeutics frequently lead to symptomatic adverse events (AEs) that can affect treatment tolerability. The National Cancer Institute has developed a patient-reported outcome (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to assess symptomatic AEs by direct patient self-report. While longitudinal assessment of patient-reported symptomatic AEs holds promise to better inform treatment tolerability, using PRO measures to assess symptomatic AEs has raised several regulatory and good clinical practice (GCP) issues among those who conduct cancer clinical trials. These include concerns regarding trial monitoring, clinical review of PRO results by investigators and delegated clinical staff, whether PRO data on symptomatic AEs require IND safety reporting, and how the trial conduct and resultant PRO data will be assessed during clinical investigator site inspections. This article addresses current thinking regarding these issues in cancer clinical trials from the Food and Drug Administration, the National Cancer Institute and the Office for Human Research Protections. PRO measures such as PRO-CTCAE that assess symptomatic AEs in cancer trials are considered similar to other PRO assessments of symptoms, function and health-related quality of life, and can generate complementary data that may inform tolerability. Clarity on operational concerns related to incorporating PRO measures to inform tolerability is critical to continue the advancement of rigorous PRO assessment in cancer clinical trials.

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