Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration.

ABSTRACT:

Importance

While there have been multiple assessments of clinical trials leading to anticancer drug approvals by the US Food and Drug Administration (FDA), the cumulative percentage of approvals based on trials with a limitation remains uncertain.

Objective

To assess the percentage of clinical trials with limitations in 4 domains-lack of randomization, lack of significant overall survival advantage, inappropriate use of crossover, and use of suboptimal control arms-that led to FDA approvals from June 30, 2014, to July 31, 2019.

Design, setting, and participants

This observational analysis included all anticancer drug indications approved by the FDA from June 30, 2014, through July 31, 2019. All indications were investigated, and each clinical trial was evaluated for d

SUBMITTER: Hilal T 

PROVIDER: S-EPMC7296449 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature