ASCO and Friends of Cancer Research Convene Meeting with FDA and Drug Industry to Identify Opportunities to Broaden Trial Eligibility Criteria

July 11, 2017

ASCO and Friends of Cancer Research (Friends) held a meeting on June 30 with key stakeholders across the cancer research community to identify concrete approaches to broaden eligibility criteria for cancer clinical trials. In addition to ASCO, Friends, and Food and Drug Administration (FDA) leadership, participants included academic and community-based researchers, patient advocates, and representatives from several types of clinical trial sponsors, including nearly twenty pharmaceutical-biotech companies, the National Cancer Institute, and the National Clinical Trials Network Groups. These stakeholders discussed implementation strategies for joint ASCO-Friends recommendations that address clinical trial eligibility criteria in four specific areas: patients with brain metastases, minimum age requirements for trial enrollment, HIV/AIDS patients, and those experiencing organ dysfunction or prior and concurrent malignancies.

Eligibility criteria are intended to ensure patient safety and define the population of a cancer clinical trial. Overly strict eligibility criteria, however, can jeopardize accrual for clinical trials and reduce applicability of trial results to the treatment of actual patients with cancer.

The meeting builds on a joint effort launched over a year ago to modernize eligibility criteria for cancer clinical trials. ASCO and Friends sought to identify areas in which eligibility criteria could be safely expanded, and established several multi-stakeholder working groups to develop recommendations to broaden eligibility criteria for specific patient populations to participate in cancer clinical trials. The first phase of this effort produced a series of manuscripts that have been submitted for peer-reviewed publication. In the next phase of the project, ASCO and Friends will work with stakeholders to advance implementation of the established recommendations.

The June 30 meeting also included a follow-up discussion from an ASCO workshop held this spring on adverse events reporting for cancer clinical trials. This presentation and resulting discussion focused on how to accurately and appropriately report adverse events that occur during a clinical trial to the FDA and change the culture of over-reporting.

Stay tuned to ASCO in Action for more news on this unique project, as well as future updates impacting the cancer research community.