Reporting of master protocols towards a standardized approach: A systematic review.

ABSTRACT:

Background

In September 2018 the FDA provided a draft guidance on master protocols reflecting an increased interest in these designs by industry. Master protocols refer to a single overarching protocol developed to evaluate multiple hypotheses and may be further categorized as basket, umbrella, and platform trials. However, inconsistencies in reporting persist in the literature. We conducted a systematic review to describe master protocol reporting with the goal of facilitating the further development and spread of these innovative trial designs.

Methods

We searched MEDLINE, EMBASE, and CENTRAL from inception to April 25, 2019 for English articles on master protocols. This was supplemented by hand searches of trial registries and of the bibliographies of published reviews. W

SUBMITTER: Siden EG 

PROVIDER: S-EPMC6616543 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature