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Cancer groups to HHS: Secure diversity in clinical trials

January 30, 2023

ASTRO joined the American Cancer Society Cancer Action Network and more than 20 others sending a letter to the Department of Health and Human Services Office of Inspector General encouraging increased diversity in clinical trials by allowing a safe harbor for covering both direct and indirect patient costs. Clinical trial logistics costs like travel, parking, lodging, child care and lost wages stifle diverse participation, and the letter to HHS proposes creation of a new regulatory safe harbor, permitting sponsors of cancer-targeting trials to cover certain indirect patient costs without violating federal kickback rules. The letter proposes regulatory language outlining specific safeguards and limitations to ensure wide participation and maintain the integrity of clinical trials.

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