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The Cost of Innovation and Evidence in Cardiac Surgery
Joanna Chikwe1, Mario Gaudino2
122494 Department of Cardiac Surgery, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Abstract:
This review summarizes a systematic analysis of 216 randomized trials of cardiovascular interventions performed during 2008-2019, according to the source of trial funding. The systematic analysis showed that on average the results of each trial would change significance if only 5 patients experienced different outcomes. Industry-sponsored trials were more likely to use composite endpoints, noninferiority designs, and twice as likely as nonindustry trials to report results favoring the device arm. Over 80% of industry trials used reporting strategies or "spin" suggesting the device arm was advantageous versus fewer than half of non-industry trials. The review discusses the implications of these findings.
Insights
Funding source impacts cardiovascular trial results. Industry-sponsored studies showed bias, with minor outcome changes potentially altering significance, highlighting the need for transparent reporting in medical research.
Area of Science:
- Cardiology
- Medical Research Methodology
- Clinical Trials
Background:
- Funding source can influence clinical trial outcomes and reporting.
- Previous analyses suggest potential biases in industry-funded research.
Purpose of the Study:
- To systematically analyze cardiovascular intervention trials based on funding source.
- To assess the impact of funding on trial design, results, and reporting strategies.
Main Methods:
- Systematic analysis of 216 randomized cardiovascular intervention trials (2008-2019).
- Comparison of trial characteristics and reported outcomes between industry-sponsored and non-industry-sponsored trials.
Main Results:
- A small change in outcomes (5 patients) could alter significance in analyzed trials.
- Industry-sponsored trials more frequently used composite endpoints and noninferiority designs.
- Industry trials were twice as likely to favor the device arm and used "spin" in over 80% of cases.
Conclusions:
- Trial funding source is associated with significant differences in design and reporting.
- Potential bias in industry-sponsored cardiovascular trials warrants careful consideration.
- Transparency in reporting is crucial for accurate interpretation of medical research findings.
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