The Evolution of Master Protocol Clinical Trial Designs: A Systematic Literature Review

Clinical Therapeutics
July 2020 Volume 42, Issue 7, p1137-1424
http://www.clinicaltherapeutics.com/current

 

Original Research
The Evolution of Master Protocol Clinical Trial Designs: A Systematic Literature Review
Recent years have seen a change in the way that clinical trials are being conducted. There has been a rise of designs more flexible than traditional adaptive and group sequential trials which allow the investigation of multiple substudies with possibly different objectives, interventions, and subgroups conducted within an overall trial structure, summarized by the term master protocol. This review aims to identify existing master protocol studies and summarize their characteristics. The review also identifies articles relevant to the design of master protocol trials, such as proposed trial designs and related methods.
Elias Laurin Meyer, Peter Mesenbrink, Cornelia Dunger-Baldauf, Hans-Jürgen Fülle, Ekkehard Glimm, Yuhan Li, Martin Posch, Franz König
p1330–1360
Published online: July 1, 2020