publication date: Feb. 12, 2021

Clinical Roundup

ASCO, Friends of Cancer Research recommend broadening eligibility criteria in cancer clinical trials

The American Society of Clinical Oncology and Friends of Cancer Research jointly issued recommendations to broaden eligibility criteria in cancer clinical trials, with the goal of making clinical trials more accessible to patients.

The joint recommendations are detailed in a series of articles published in Clinical Cancer Research, a journal of the American Association for Cancer Research. The series provides a comprehensive examination of eligibility criteria for cancer clinical trials with recommendations to address five specific areas: treatment washout periods, concomitant medications, prior therapies, laboratory reference ranges and test intervals, and patient performance status.

“Clinical trial access must be recognized as a health equity issue. Overly restrictive eligibility criteria without scientific justification has led to an underrepresentation of older adults, racial/ethnic and sexual/gender minorities, and patients with well-managed comorbidities,” ASCO President Lori J. Pierce, said in a statement.

Trial eligibility criteria are designed to protect participant safety and define an appropriate study population. However, overly restrictive eligibility criteria can limit the participation of patients in a clinical trial who share critical characteristics with those likely to be treated based on the study’s results. These restrictions make it hard for clinicians to fully understand how a more diverse patient population typically seen in clinical practice will respond to a therapy post-approval.

Overly restrictive eligibility criteria can also reduce patient access to potentially life-prolonging novel treatments and slow down the generation of research results. Using recommendations made by ASCO and Friends in 2017, an analysis of data from CancerLinQ Discovery (CancerLinQ’s deidentified real-world data product for researchers) found that expanding three common eligibility criteria—renal function … Continue reading ASCO, Friends of Cancer Research recommend broadening eligibility criteria in cancer clinical trials

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