The Proportion of Randomized Controlled Trials That Inform Clinical Practice: A Longitudinal Cohort Study of Trials Registered on ClinicalTrials.gov

Abstract

Background 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. Methods 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. 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. Conclusions 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.

Competing Interest Statement

JK received consulting fees from Amylyx Inc. Authors declare no other potential conflicts of interest.

Clinical Trial

Not Applicable

Clinical Protocols

https://osf.io/3egku/

Funding Statement

This study was funded by the Fonds de recherche Santé Québec postdoctoral research grant (NH). This funding body was not involved in study design, conduct or reporting.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Not Applicable

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Our study was not subject to Institutional Review Board approval, as it relied on publicly accessible data.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Not Applicable

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Not Applicable

Data Availability

Our manuscript relies on publicly available data from ClinicalTrials.gov. Our data set is available online on Open Science Framework (DOI 10.17605/OSF.IO/3EGKU) (reference 18).

https://osf.io/3egku/

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