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How to limit uninformative trials: Results from a Delphi working group.

Luke Gelinas1, Nora Hutchinson2, Deborah A Zarin2

  • 1Advarra, Inc, Columbia, MD, USA; Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Cambridge, MA, USA.

Med (New York, N.Y.)
|April 15, 2023
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Summary

Clinical trials must yield informative results to be justifiable. A Delphi process identified 35 recommendations to improve scientific review and prevent uninformative clinical trials.

Keywords:
Delphiclinical trialsinformativeresearch wastescientific review

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Area of Science:

  • Clinical research methodology
  • Evidence-based medicine

Background:

  • Many clinical trials fail to test novel hypotheses or produce informative results, undermining their justification.
  • The scientific and ethical imperative for clinical trials necessitates rigorous evaluation to ensure meaningful outcomes.

Purpose of the Study:

  • To establish consensus on recommendations aimed at preventing uninformative clinical trials.
  • To define the role of scientific review in enhancing the quality and informativeness of clinical trial research.

Main Methods:

  • A modified Delphi process was employed to achieve expert consensus.
  • The consensus-building process focused on identifying key areas for improving scientific review.

Main Results:

  • Thirty-five distinct recommendations were developed across five critical domains.
  • Consensus was reached on strategies to enhance the scientific rigor and informativeness of clinical trials.

Conclusions:

  • Implementing these 35 recommendations can significantly improve the scientific review process.
  • Enhancing scientific review is crucial for ensuring that clinical trials are justifiable and yield valuable, informative results.