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Characteristics of Contemporary Randomized Clinical Trials and Their Association With the Trial Funding Source in
Mario Gaudino1, Irbaz Hameed1, Mohamed Rahouma1
1Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, New York.
JAMA Internal Medicine
|June 2, 2020
Summary
Commercial sponsorship in cardiovascular trials is linked to biased reporting of favorable outcomes. These randomized clinical trials (RCTs) are often small, with short follow-up, impacting evidence-based practice.
Area of Science:
- Cardiovascular Medicine
- Clinical Trials Methodology
- Medical Device Research
Background:
- High-quality randomized clinical trials (RCTs) are crucial for evidence-based practice and guideline development.
- Commercial entities frequently fund, design, conduct, and report on clinical trials, necessitating an analysis of their influence.
Purpose of the Study:
- To assess the design, outcomes, and reporting of recent randomized clinical trials (RCTs) in invasive cardiovascular interventions.
- To determine the association between trial funding sources (specifically commercial sponsorship) and study characteristics and results.
Main Methods:
- A cross-sectional analysis of published RCTs in interventional cardiology and cardiovascular/vascular surgery from January 1, 2008, to May 31, 2019.
- Evaluation of trial characteristics, statistical significance of primary endpoints, reporting of implied treatment advantages, discrepancies between registered and published outcomes, and the sensitivity of results to small changes in patient outcomes.
- Assessment of the association between commercial sponsorship and these measures.
Main Results:
- Of 216 RCTs, 53.2% had commercial sponsorship. Trials were often small (median 502 patients) with short follow-up (median 12 months).
- Commercial sponsorship was significantly associated with reporting favorable outcomes (OR 2.80) and inconsistent findings.
- Discrepancies between registered and published primary outcomes occurred in 38.0% of trials, irrespective of sponsorship. Commercial sponsorship was linked to a higher number of patients needed to change significance (OR 1.29).
Conclusions:
- Contemporary RCTs in invasive cardiovascular interventions are often underpowered, small, and have limited follow-up.
- Commercial sponsorship appears linked to differences in trial design, outcome reporting, and potentially biased results, influencing the evidence base.
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