Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review.

ABSTRACT:

Objective

To characterize the types of comparators and endpoints used in efficacy trials for approvals of supplemental indications, compared with the data supporting these drugs' originally approved indications.

Design

Systematic review.

Setting

Publicly accessible data on supplemental indications approved by the US Food and Drug Administration from 2005 to 2014.

Main outcome measures

Types of comparators (active, placebo, historical, none) and endpoints (clinical outcomes, clinical scales, surrogate) in the efficacy trials for these drugs' supplemental and original indication approvals.

Results

The cohort included 295 supplemental indications. Thirty per cent (41/136) of supplemental approvals for new indications were supported by efficacy trials with a

SUBMITTER: Wang B 

PROVIDER: S-EPMC4580725 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature