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Development of a conceptual framework for defining trial efficiency.

Charis Xuan Xie1, Anna De Simoni1, Sandra Eldridge1

  • 1Wolfson Institute of Population Health, Queen Mary University of London, London, England, United Kingdom.

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|May 23, 2024
PubMed
Summary
This summary is machine-generated.

This study defines trial efficiency by identifying four constructs: scientific, operational, statistical, and economic. It also outlines five building blocks for efficient trials, including design, process, infrastructure, superstructure, and stakeholders.

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Area of Science:

  • Clinical trial methodology
  • Health services research

Background:

  • Growing global emphasis on efficient clinical trials.
  • Significant heterogeneity exists in understanding trial efficiency.
  • Need for a comprehensive conceptual framework to define trial efficiency.

Purpose of the Study:

  • To gather diverse perspectives on trial efficiency.
  • To establish a consensus-based conceptual framework for defining trial efficiency.

Main Methods:

  • Literature review of 78 studies to identify terms related to trial efficiency.
  • Modified e-Delphi study with 49 international experts (trialists, funders, sponsors, editors, public).
  • Consensus defined by the UCLA/RAND approach for inter-percentile range.

Main Results:

  • Identified nine terms defining trial efficiency.
  • Achieved consensus on four constructs: scientific, operational, statistical, and economic efficiency.
  • Achieved consensus on five building blocks: trial design, process, infrastructure, superstructure, and stakeholders.

Conclusions:

  • First attempt to dissect trial efficiency into theoretical constructs.
  • An agreed definition will improve trial implementation, communication, and decision-making.
  • Identified essential building blocks for efficient trials, paving the way for future evaluation frameworks.