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More liberal criteria could greatly expand clinical trial participation



– Fewer than 1 in 20 adults with cancer enroll in clinical trials, and even when cancer patients are willing to participate in a trial, they are often excluded because of comorbidities, prior therapies, or a host of other factors that could confound results.

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But as a team of investigators shows in a proof-of-concept study, more generous exclusion criteria in some trials could nearly double the number of participants. Using retrospective, deidentified electronic health record data from the American Society of Clinical Oncology CancerLinQ Discovery database, R. Donald Harvey, PharmD and colleagues found that when they applied broader inclusion criteria for patients with advanced non–small cell lung cancer (NSCLC), the number of patients who would be eligible for clinical trials nearly doubled from 5,495 to 10,349.

In this video interview from the ASCO annual meeting, Dr. Harvey of the Winship Cancer Institute of Emory University in Atlanta discusses collaborations between the oncology community, federal agencies, and the pharmaceutical industry that could improve clinical trials by safely increasing sample sizes.

The study received funding from ASCO. Dr. Harvey disclosed consulting or advisory roles with and institutional research funding from multiple entities.

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