Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.

ABSTRACT:

Importance

Drugs treating serious or life-threatening conditions can receive US Food and Drug Administration (FDA) accelerated approval based on showing an effect in surrogate measures that are only reasonably likely to predict clinical benefit. Confirmatory trials are then required to determine whether these effects translate to clinical improvements.

Objective

To characterize preapproval and confirmatory clinical trials of drugs granted accelerated approval.

Design and setting

Publicly available FDA documents were reviewed to identify the preapproval trials leading to accelerated approval between 2009 and 2013. Information on the status and findings of required confirmatory studies was extracted from the FDA's database of postmarketing requirements and commitments,

SUBMITTER: Naci H 

PROVIDER: S-EPMC5817559 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature