The proportion of randomized controlled trials that inform clinical practice

Abstract
Data availability
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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

Nora Hutchinson

Studies of Translation, Ethics and Medicine, McGill University, Montreal, Canada

Competing interests
No competing interests declared.

"This ORCID iD identifies the author of this article:" 0000-0003-1349-8592
Hannah Moyer

Studies of Translation, Ethics and Medicine, McGill University, Montreal, Canada

Competing interests
No competing interests declared.
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..
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.

"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.

Copyright

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.