Initiative to Modernize Eligibility Criteria for Clinical Trials Launched

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ASCO and Friends of Cancer Research (Friends) have launched a collaborative effort to modernize eligibility criteria to promote greater patient participation in cancer clinical trials.

Although it is important for defining the population under study and ensuring patient safety, overly strict eligibility criteria may limit clinical trial accrual, the generalizability of trial results to the larger population of cancer patients, and patient access to investigational therapies.

The ASCO/Friends initiative is designed to identify opportunities where eligibility criteria could be broadened and ultimately influence investigators and sponsors to adjust these criteria where clinically appropriate. The two organizations have established a multidisciplinary group of more than 40 stakeholders from across the cancer research community, including patient advocates; clinical investigators; drug and biotechnology manufacturers; pharmacologists; and medical reviewers from the U.S. Food and Drug Administration (FDA).

On May 12, groups presented their initial recommendations for discussion at a closed workshop that was attended by additional patient advocates, officials from the FDA, and drug and biotech manufacturers. The working groups will finalize consensus recommendations, with the ultimate plan of submission for publication in a peer-reviewed journal expected later this year. ■

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