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FDA Expands Eligibility for Cancer Trials in Five Guidance Documents

To broaden patient participation in cancer clinical trials, the US Food and Drug Administration (FDA) in March released four draft guidance documents on cancer clinical trial eligibility criteria, and one final guidance document on including adolescents in adult oncology trials. Bronwyn Mixter, Clarivate, identifies how these guidance documents provide recommendations on how sponsors can safely and effectively broaden clinical trial criteria to include certain patient populations.