Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021

Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021

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Single-arm trials have allowed for transformative therapies to be made available to patients expeditiously. However, using single-arm trials to support drug approval presents several challenges that must be carefully considered.