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This cohort study assesses the validity of molecular targets and therapeutic benefits of US Food and Drug Administration (FDA)–approved genome-targeted cancer drugs based on the outcomes of their corresponding pivotal clinical trials.

This study matches entries in ClinicalTrials.gov for cancer drug trials at initiation of the trial with later entries and with journal reports of the trials to assess modifications in trial design, external factors associated with such modifications, and transparency in reporting them.

This study uses the European Society of Medical Oncology Magnitude of Clinical Benefit Scale to evaluate the clinical benefit of anticancer drugs that gained approval by the US Food and Drug Administration based on single-arm rather than randomized clinical trials.