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

Jay J H Park1,2, Ellie Siden2, Michael J Zoratti3

  • 1Experimental Medicine, Department of Medicine, 10th Floor, 2775 Laurel Street, Vancouver, BC, V5Z 1M9, Canada.

Trials
|September 20, 2019
PubMed
Abstract

Insights

Master protocols, including basket, umbrella, and platform trials, are efficient and ethical clinical trial designs. Their use is rapidly increasing, particularly in oncology, with more awareness and training needed for broader application.

Area of Science:

  • Clinical trial design
  • Biostatistics
  • Translational research

Background:

  • Master protocols (basket, umbrella, platform trials) offer efficient, ethical, multi-hypothesis clinical trial evaluation.
  • Despite advantages, these innovative designs are underutilized in clinical research.

Purpose of the Study:

  • To conduct a landscape analysis of master protocols to improve understanding of their current use.
  • To identify trends and characteristics of implemented master protocols.

Main Methods:

  • Systematic literature search of MEDLINE, EMBASE, and CENTRAL databases, including hand searches.
  • Data collected on master protocols identified up to July 8, 2019.
  • Analysis focused on trial design, interventions, populations, and outcomes.

Main Results:

  • Identified 83 master protocols (49 basket, 18 umbrella, 16 platform), with rapid recent growth.
  • Most trials were in oncology, investigating experimental drugs, primarily in the US.
  • Basket and umbrella trials were mostly exploratory and non-randomized; platform trials were predominantly randomized and phase III.

Conclusions:

  • Master protocol utilization is projected to increase significantly in the coming decades.
  • Increased awareness and training are crucial to expand the application of these designs beyond oncology.
Keywords:
Basket trialsMaster protocolsMulti-arm, multi-stage designPlatform trialsUmbrella trials

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