Related Experiment Video
Updated: Mar 19, 2026
In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
Trends in Consent for Clinical Trials in Cardiovascular Disease
Louis A Kerkhoff1, Javed Butler2, Anita A Kelkar3
1Medical College of Georgia-University of Georgia Medical Partnership, Augusta University, Athens, GA.
Insights
Patient acceptance rates in cardiovascular clinical trials are high (median 83.2%), suggesting other factors drive low enrollment. Reporting of enrollment data needs improvement for better trial generalizability.
Area of Science:
- Cardiology
- Clinical Trials
- Health Services Research
Background:
- Patient enrollment is crucial for cardiovascular clinical trials.
- Inadequate enrollment rates are a concern, but patient acceptance trends are poorly understood.
- This study aimed to analyze patient acceptance of cardiovascular clinical trial enrollment.
Purpose of the Study:
- To assess trends in patient acceptance of cardiovascular clinical trial offers.
- To identify predictors of patient acceptance in cardiovascular disease clinical trials.
Main Methods:
- A systematic review of 1224 randomized, controlled cardiovascular trials published between 2001-2012.
- Included studies published in top-tier general medical and cardiology journals.
- Extracted data on approached patients and enrollment refusals; acceptance rate calculated.
Main Results:
- Only 21.7% of studies provided sufficient data for acceptance rate calculation.
- The median patient acceptance rate was 83.2%.
- Higher enrollment was associated with acute care settings, geographical region, and trial sponsorship.
Conclusions:
- Low reporting rates of enrollment data hinder identification of enrollment barriers and trial generalizability.
- High patient acceptance rates suggest factors beyond patient choice influence trial enrollment.
- Improving data reporting is essential for understanding and addressing enrollment challenges.
Background:
Cardiovascular clinical trials depend on patient enrollment. Enrollment rates appear inadequate, but little is known about how frequently patients accept or decline offers of enrollment. The objective of this study was to assess trends and predictors of patient acceptance of offers to enroll in clinical trials for cardiovascular disease.
Methods And Results:
We utilized an established database containing all randomized, controlled trials (n=1224) in cardiovascular disease published between 2001 and 2012 in the 8 highest-impact general medical and cardiology journals. Studies were eligible if the number of patients approached and number of patients declining enrollment could be ascertained from published materials. All studies were screened for eligibility. Each eligible study was reviewed by 3 co-authors. All discrepancies were resolved by the group. The main outcome was acceptance rate, defined as the number of patients enrolled divided by the number patients who were eligible and approached. Only 21.7% (n=266) of studies provided information sufficient to assess patient enrollment and refusals. The median acceptance rate across trials was 83.2%. Significant predictors of higher enrollment included: enrollment in the acute setting (P=0.031); geographical region (P<0.001 for group); and trial sponsorship (P=0.006 for group).
Conclusions:
Rates of reporting data sufficient to calculate acceptance rates are low. This compromises the ability to identify drivers of low enrollment and assess trial generalizability. However, the high rates of acceptance observed suggest that factors other than patients' decisions may be the primary drivers of declining rates of trial enrollment.
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