Table 1.

Current thinking on trial monitoring and clinical review of PRO symptomatic AE responses during the conduct of oncology clinical trials

Topics of concernCurrent thinking
What degree of trial monitoring should be employed to ensure completion of PRO measures?
Ongoing review of compliance with PRO measure completion
  • Completion rate should be reviewed by the sponsor regularly throughout clinical trial conduct, with prospective procedures put in place to minimize missing data.

  • Reasons for missing PRO data should be captured to the extent possible.

What level of clinical review should be employed during trial conduct for PRO measures of symptomatic AEs in cancer clinical trials?
Clinical review of individual patient-level PRO data by clinical investigators and delegated clinical staff during trial conduct
  • The degree of real-time clinical review of individual patient-level PRO data by clinical investigators during trial conduct is the decision of the sponsor (as defined by the protocol and monitoring plan), IRB, and the data and safety monitoring board (DSMB).

  • The degree of clinical review is informed by the clinical trial context (e.g., regimen and patient population).

  • A rationale should be provided in the monitoring plan for the degree of clinical review of PRO data employed to ensure patient safety for the trial context.

  • The informed consent document should clearly state if and when PRO data will be shared with clinical investigators during the clinical trial.

  • If PRO data are not shared with clinical investigators in real time, patients should be reminded of this as they complete each PRO assessment and instructed to contact their treating clinician for any concerning sign or symptom.

  • Although not currently standard practice, use of PRO measures to inform clinical evaluation for symptom management is a promising area of active investigation.