The ECOG-ACRIN Cancer Research Group’s (ECOG-ACRIN) Patient-Reported Outcomes (PRO) Working Group established the PRO Advisory Group (PROAG or Advisory Group) three years ago. This subgroup is part of the PRO Working Group’s broader vision to increase the incorporation of the patient voice in ECOG-ACRIN clinical trials, and thereby strengthen the scientific evidence base to enhance cancer care and outcomes.

PROs are health outcomes directly reported by the patient, without interpretation by a clinician or anyone else. PROs are assessed using validated measures that allow patients to directly report on their health status, including disease symptoms, treatment side-effects, functioning, and emotional and social well-being. Incorporating PROs ensures that researchers consider patient experiences during the trial alongside the primary outcome measures for that trial. Also, having PROs in a trial can provide additional data on drug efficacy and tolerability in the oncology clinical trial setting, to better inform the interpretation of the trial results.

The PROAG’s primary role is to guide investigators on how best to include PRO measures and endpoints in selected ECOG-ACRIN phase 2 and 3 trials. The PROAG members advise on study design, measure selection, assessment timing, data collection methods, statistical analysis, and allocation of support for protocol development and manuscript preparation.

The Advisory Group comprises individuals from multiple disciplines, such as outcomes measurement scientists, statisticians, and experts in psychosocial oncology. They meet monthly to review clinical trial concepts, assess PRO-related protocol amendments, discuss recent quality-of-life findings, and provide scientific and implementation insights for ECOG-ACRIN trials. During the development of a clinical trial, PRO advisors will collaborate closely with protocol development specialists in the ECOG-ACRIN Operations Office to provide direct feedback, and they will discuss opportunities with study teams.

The PROAG members frequently collaborate with investigators and chairs of the ECOG-ACRIN disease-oriented committees to identify individuals with appropriate expertise to serve as PRO study co-chairs on their trials. PRO study co-chairs offer direct support to study teams while the trial is open and participants are being enrolled. These individuals also provide critical support during the subsequent trial analysis, evaluation, and results dissemination. For every trial with a PRO study co-chair, their input strengthens the scientific evidence base to enhance cancer care and outcomes for that group of patients. More broadly, their involvement in the trial contributes to the advancement of PRO science.

If you are interested in learning more about PROs in clinical trials, becoming a PRO advisor, or you are an investigator who would like to receive insights on a trial you are developing, please reach out to your protocol development specialist or email the PROAG directly.

The PRO Working Group is led by John (Devin) Peipert, PhD (University of Birmingham), Ilana F. Gareen, PhD (Brown University), and Lari Wenzel, PhD (University of California Irvine/Chao Family Comprehensive Cancer Center). It is one of several committees in ECOG-ACRIN’s large Cancer Control and Outcomes Program. Learn more at ecog-acrin.org.