ASCO, Friends of Cancer Research Release Recommendations to Broaden Clinical Trials Eligibility Criteria

Oct 22, 2017

ASCO and Friends of Cancer Research (Friends) are calling for the use of more inclusive eligibility criteria for cancer clinical trials. This recommendation was made in conjunction with the release of a Special Series, published online in the Journal of Clinical Oncology (JCO) in October 2017. The series provides a comprehensive examination of eligibility criteria for cancer clinical trials with recommendations to address eligibility criteria in five specific areas: minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.

Eligibility criteria are intended to protect the safety of trial participants—particularly those populations that may be more vulnerable to adverse events of a trial drug—as well as define the trial population. Overly restrictive eligibility criteria, however, can impede patient accrual to cancer clinical trials and reduce the generalizability of trial results, making findings more difficult to apply to treatment of real-world patients with cancer.

When ASCO and Friends launched the joint project in 2016, five areas were identified where eligibility criteria were most likely to restrict a patient’s participation in a trial, but least likely to affect participant safety. Working groups comprised of researchers, patient advocates, regulators, and industry representatives examined each of the five areas and made recommendations on modifying the specific inclusion and exclusion criteria that often restrict the participation of patients. ASCO and Friends worked closely with the U.S. Food and Drug Administration (FDA) throughout the project.

The working groups generally found that concerns that have contributed to the historic exclusion of certain groups of patients are often not supported by data. Additionally, since drugs are usually not tested in these specific patient populations until extensive preliminary study has been completed, or after the drug has been approved, arbitrarily excluding these patients limits their access to novel cancer agents and, thus, their ability to benefit from emerging advances in cancer treatment. Moreover, when treating these patients in clinical practice, there is often limited available data on safety and efficacy of drugs for these specific patient populations—patients who may make up a large subset of those with a particular type of cancer.

The Special Series also includes an FDA analysis of Investigational New Drug applications from 2015. Authored by FDA officials, including Director of the FDA’s Oncology Center of Excellence Richard Pazdur, MD, the analysis provides further insight into the exclusions of patient populations resulting from common eligibility criteria in cancer trials today, and possible opportunities to broaden eligibility criteria to include more patients in clinical studies.  

Building off this effort, ASCO and Friends held a meeting in June 2017 to discuss the implementation of these broader eligibility criteria with stakeholders across the research community, including 19 drug/biotech manufacturers, FDA, the National Cancer Institute (NCI) Cooperative Groups, and NCI. The organizations will continue to work with clinical trial sponsors and regulators to turn these recommendations into action and identify additional opportunities to safely expand eligibility criteria for oncology trials.

Access the Special Series online at ascopubs.org/JCO


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