Related Experiment Video
Updated: Dec 4, 2025
In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
Study design, result posting, and publication of late-stage cardiovascular trials
Chris J Kapelios1,2, Huseyin Naci2, Panos E Vardas3
1Cardiology Department, Laiko General Hospital, 17 Agiou Thoma Street, 11 527 Athens, Greece.
Insights
Few late-stage cardiovascular trials report results on ClinicalTrials.gov or in publications. Industry sponsorship influences results reporting and publication, with sponsored studies more likely posted but less likely published.
Area of Science:
- Cardiovascular Disease Research
- Clinical Trial Analysis
- Publication Ethics
Background:
- Pre-registration of study protocols is mandated for publication in high-impact journals.
- Limited data exists on the characteristics and outcomes of registered clinical trials, particularly regarding result reporting and publication.
Purpose of the Study:
- To analyze the characteristics of interventional, late-phase cardiovascular disease (CVD) trials registered in ClinicalTrials.gov.
- To assess the rates of results reporting and publication for these trials.
- To examine factors associated with results posting and publication, including industry sponsorship.
Main Methods:
- Searched ClinicalTrials.gov for adult CVD trials posted after January 1, 2013, and completed by December 31, 2018.
- Collected data on study design, sponsorship, intervention type, primary outcomes, results posting, and publication.
- Utilized multivariate analysis to identify factors associated with results posting and publication.
Main Results:
- 250 CVD trials were analyzed; 77.2% were randomized, 39.6% open-label, and 50.4% industry-sponsored.
- Most trials (71.6%) evaluated drugs, and 76.0% used non-clinical primary outcomes.
- Only 25.2% had results posted on ClinicalTrials.gov, and 46.4% were published. Industry sponsorship was linked to higher results posting (OR: 3.38) but lower publication rates (OR: 0.41).
Conclusions:
- A significant gap exists in results reporting and publication for late-stage cardiovascular trials.
- Industry sponsors disproportionately focus on patent-protected interventions.
- While industry sponsorship increases the likelihood of posting results, it is associated with a decreased likelihood of publication in scientific literature.
Aims:
Pre-registration of study protocols in accessible databases is required for publication of study results in high-impact medical journals. Nonetheless, data on characteristics of clinical trials registered in these databases and their outcome, in terms of result reporting and publication are limited.
Methods And Results:
We searched for interventional, late-phase cardiovascular disease (CVD) studies in adults registered in Clinicaltrials.gov. first posted after 1 January 2013 and completed up to 31 December 2018. Data on study design, result reporting, and publication were collected, and potential associations with a pre-defined set of explanatory factors were examined. In total, 250 CVD trials were included in the analysis. Of these, 193 (77.2%) were randomized studies, 99 (39.6%) open label designs, and 126 (50.4%) had industry as main sponsor. One hundred and seventy-nine trials (71.6%) evaluated the effect of drugs and 27 (10.8%) evaluated devices. The most common primary outcomes were non-clinical endpoints (76.0%), with only 17% of studies evaluating clinical endpoints. Industry-funded trials focused on patent-protected drugs and devices more often than non-industry-funded trials (72.0% vs. 30.6%, P < 0.001 and 55.0% vs. 26.3%, P = 0.033, respectively). Sixty-three studies (25.2%) had results posted on clinicaltrials.gov, and 116 (46.4%) had results published in the scientific literature. In multivariate analysis, industry sponsorship was statistically significantly associated with results posting [odds ratio (OR): 3.38; 95% confidence interval (CI): 1.56-7.30, P = 0.002] and publication (OR: 0.41; 95% CI: 0.23-0.75, P = 0.004).
Conclusion:
Among late-stage cardiovascular trials only one-fourth had results posted on clinicaltrials.gov and <50% had results published. Industry sponsors were more likely to invest in research on patent-protected drugs and devices than were non-industry sponsors. Industry-sponsored studies were more likely to have their results posted, but less likely to have their results published in the scientific literature.
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