On Friday, April 9, 2021, ASCO and Friends of Cancer Research (Friends) co-hosted a live virtual event, which brought together experts from across the health-care sector to discuss the recent release of the new ASCO-Friends recommendations for modernizing eligibility criteria to improve patient access and representation in cancer clinical trials.1 ASCO-Friends recommendations address five specific areas: treatment washout periods, concomitant medications, prior therapies, laboratory reference ranges and test intervals, and patient performance status.
The live event was broadcast through YouTube and is available to view at https://www.youtube.com/watch?v=WAbdJ_7gjZ8.
The event opened with 2020–2021 ASCO President, Lori J. Pierce, MD, FASTRO, FASCO, who expressed hope that the new recommendations on eligibility criteria would make clinical trials more inclusive and accessible. Ellen Sigal, PhD, Founder and Chair of Friends of Cancer Research, also addressed participants and explained the ongoing effort and attention this initiative has demanded, and the importance of the relationship between ASCO and Friends to advance meaningful change to overly restrictive eligibility criteria.
During a keynote panel, Ed Kim, MD, MBA, FACP, FASCO, Physician-in-Chief at City of Hope Orange County, moderated a discussion between Ned Sharpless, MD, Director of the National Cancer Institute, and Janet Woodcock, MD, Acting Commissioner of the U.S. Food and Drug Administration. The panelists focused on what methods of conducting clinical trials should be altered, how to improve accrual and representation, and what lessons can be learned from the COVID-19 pandemic when it comes to clinical trials.
Dr. Woodcock emphasized the importance of integrating research into clinical practices and explained that the best way to reach diverse participants is by engaging their usual practitioners to ease patients’ concerns and burdens around trials. Dr. Sharpless added that bringing clinical trials closer to home—both by building infrastructure at more care facilities and by using telemedicine and other technologies—will allow greater patient participation.
R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA, of Winship Cancer Institute, Emory University School of Medicine, provided an overview of one of the articles focused on modernizing eligibility criteria, “Impact of Broadening Clinical Trial Eligibility Criteria for Advanced Non–Small Cell Lung Cancer Patients: Real-World Analysis.”2 Using a cohort of 10,500 patients with non–small cell lung cancer from ASCO’s CancerLinQ Discovery database, the potential impact analysis demonstrated that the number of patients eligible for clinical trials could nearly double if modernized eligibility criteria were used, compared with traditional inclusion/exclusion criteria.
The final panel featured Tom Uldrick, MD, MS, of Fred Hutchinson Cancer Research Center (moderator); Julia Beaver, MD, of the U.S. Food and Drug Administration; Raymond P. Perez, MD, of Bristol Myers Squibb; and Patty Spears, BS, a patient advocate. Their discussion was centered around the importance of broadening clinical trial eligibility to make trials more equitable; the risks of clinical trials and broadening eligibility to mitigate them; and the implications of broadening eligibility for sponsors.
“Patients actively looking for clinical trials as treatment options are frustrated navigating this maze of eligibility, and many times are disappointed when they don’t qualify,” said Ms. Spears. “Patients have been really waiting for this.”
ASCO-Friends will continue partnering on strategies to implement and encourage the adoption of the updated clinical trial eligibility recommendations.
1. Kim ES, Uldrick TS, Schenkel C, et al: Continuing to broaden eligibility criteria to make clinical trials more representative and inclusive: ASCO–Friends of Cancer Research joint research statement. Clin Cancer Res 27:2394-2399, 2021.
2. Harvey RD, Rubinstein WS, Ison G, et al: Impact of broadening clinical trial eligibility criteria for advanced non-small cell lung cancer patients: Real-world analysis. J Clin Oncol 37(suppl):LBA108, 2019.
© 2021. American Society of Clinical Oncology. All rights reserved.