The proportion of randomized controlled trials that inform clinical practice

  1. Nora Hutchinson
  2. Hannah Moyer
  3. Deborah A Zarin
  4. Jonathan Kimmelman  Is a corresponding author
  1. McGill University, Canada
  2. Brigham and Women's Hospital, United States

Abstract

Prior studies suggest that clinical trials are often hampered by problems in design, conduct and reporting that limit their uptake in clinical practice. We have described 'informativeness' as the ability of a trial to guide clinical, policy or research decisions. Little is known about the proportion of initiated trials that inform clinical practice. We created a cohort of randomized interventional clinical trials in three disease areas (ischemic heart disease, diabetes mellitus and lung cancer), that were initiated between 1 January 2009 and 31 December 2010 using ClinicalTrials.gov. We restricted inclusion to trials aimed at answering a clinical question related to the treatment or prevention of disease. Our primary outcome was the proportion of clinical trials fulfilling four conditions of informativeness: importance of the clinical question, trial design, feasibility, and reporting of results. Our study included 125 clinical trials. The proportion meeting four conditions for informativeness was 26.4% (95% CI 18.9 - 35.0). Sixty-seven percent of participants were enrolled in informative trials. The proportion of informative trials did not differ significantly between our three disease areas. Our results suggest that the majority of clinical trials designed to guide clinical practice possess features that may compromise their ability to do so. This highlights opportunities to improve the scientific vetting of clinical research.

Data availability

The data set is available online on Open Science Framework (DOI 10.17605/OSF.IO/3EGKU) (reference 18 in the manuscript).

Article and author information

Author details

  1. Nora Hutchinson

    Studies of Translation, Ethics and Medicine, McGill University, Montreal, Canada
    Competing interests
    No competing interests declared.
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0003-1349-8592
  2. Hannah Moyer

    Studies of Translation, Ethics and Medicine, McGill University, Montreal, Canada
    Competing interests
    No competing interests declared.
  3. Deborah A Zarin

    Multi-Regional Clinical Trials Center, Brigham and Women's Hospital, Boston, United States
    Competing interests
    Deborah A Zarin, received payment as consultant for National Library of Medicine, NIH, for scientific advice to ClinicalTrials.gov and received grants from the Greenwall Foundation..
  4. Jonathan Kimmelman

    Studies of Translation, Ethics and Medicine Research Group, Biomedical Ethics Unit, McGill University, Montreal, Canada
    For correspondence
    jonathan.kimmelman@mcgill.ca
    Competing interests
    Jonathan Kimmelman, received consulting fees from Amylyx Inc and payments from Biomarin. JK participated on Data Safety Monitoring Boards for NIAID and Ultragenyx.
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0003-1614-6779

Funding

Fonds de Recherche du Québec - Santé

  • Nora Hutchinson

The funders had no role in study design, data collection and interpretation, or the decision to submit the work for publication.

Reviewing Editor

  1. Philip Boonstra, University of Michigan, United States

Publication history

  1. Received: April 14, 2022
  2. Preprint posted: May 13, 2022 (view preprint)
  3. Accepted: August 15, 2022
  4. Accepted Manuscript published: August 17, 2022 (version 1)
  5. Version of Record published: August 30, 2022 (version 2)

Copyright

© 2022, Hutchinson et al.

This article is distributed under the terms of the Creative Commons Attribution License permitting unrestricted use and redistribution provided that the original author and source are credited.

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  1. Nora Hutchinson
  2. Hannah Moyer
  3. Deborah A Zarin
  4. Jonathan Kimmelman
(2022)
The proportion of randomized controlled trials that inform clinical practice
eLife 11:e79491.
https://doi.org/10.7554/eLife.79491

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