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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
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.
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.
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