Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols.

ABSTRACT:

Background

Master protocols, classified as basket trials, umbrella trials, and platform trials, are novel designs that investigate multiple hypotheses through concurrent sub-studies (e.g., multiple treatments or populations or that allow adding/removing arms during the trial), offering enhanced efficiency and a more ethical approach to trial evaluation. Despite the many advantages of these designs, they are infrequently used.

Methods

We conducted a landscape analysis of master protocols using a systematic literature search to determine what trials have been conducted and proposed for an overall goal of improving the literacy in this emerging concept. On July 8, 2019, English-language studies were identified from MEDLINE, EMBASE, and CENTRAL databases and hand searches of pub

SUBMITTER: Park JJH 

PROVIDER: S-EPMC6751792 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature