Diminishing clinical impact for post-approval cancer clinical trials: A retrospective cohort study.

ABSTRACT:

Background

Once a drug gets FDA approved, researchers often attempt to discover new applications in different indications. The clinical impact of such post-approval activities is uncertain. We aimed to compare the clinical impact of research efforts started after approval with those started before for cancer drugs.

Methods

We used Drugs@FDA to perform a retrospective cohort study of secondary approvals for cancer drugs that were initially FDA approved between 2005 and 2017. Clinicaltrials.gov was used to identify the beginning of each research trajectory that resulted in a secondary FDA approval. Each trajectory was classified as pre- or post-approval depending on if it was initiated before or after initial drug licensure. Clinical impact was assessed by comparing secondary

SUBMITTER: Ouimet C 

PROVIDER: S-EPMC9467301 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature