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Updated: Mar 13, 2026

In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
The Changing Landscape of Randomized Clinical Trials in Cardiovascular Disease
W Schuyler Jones1, Matthew T Roe1, Elliott M Antman2
1Department of Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
Insights
Cardiovascular disease clinical trials are evolving due to rising costs and complexity. This review explores current US trials, registry-based studies, and the innovative ADAPTABLE pragmatic trial.
Area of Science:
- Cardiology
- Clinical Trials
- Health Services Research
Background:
- Cardiovascular disease clinical trials have significantly advanced cardiology practice over 30 years.
- A substantial need persists for high-quality evidence due to the global rise in cardiovascular disease.
- Traditional clinical trials face challenges including rising costs, complexity, and regulatory burdens.
Purpose of the Study:
- To review the current landscape of cardiovascular clinical trials in the United States.
- To highlight recently conducted registry-based clinical trials.
- To discuss the potential attributes of the ADAPTABLE pragmatic clinical trial.
Main Methods:
- Review of current cardiovascular clinical trials in the US.
- Examination of recently conducted registry-based clinical trials.
- Discussion of the ADAPTABLE pragmatic clinical trial design and potential.
Main Results:
- Not applicable for this review-focused abstract.
- Not applicable for this review-focused abstract.
- Not applicable for this review-focused abstract.
Conclusions:
- The landscape of cardiovascular clinical trials is shifting towards more efficient and patient-centered methodologies.
- Registry-based and pragmatic trials, such as ADAPTABLE, offer potential solutions to the challenges of traditional clinical trials.
- Continued innovation in trial design is crucial for generating high-quality evidence in cardiovascular medicine.
Abstract:
Large randomized clinical trials in cardiovascular disease have proliferated over the past 3 decades, with results that have influenced every aspect of cardiology practice. Despite these advances, there remains a substantial need for more high-quality evidence to inform cardiovascular clinical practice, given the increasing prevalence of cardiovascular disease around the world. Traditional clinical trials are increasingly challenging due to rising costs, increasing complexity and length, and burdensome institutional and regulatory requirements. This review will examine the current landscape of cardiovascular clinical trials in the United States, highlight recently conducted registry-based clinical trials, and discuss the potential attributes of the recently launched pragmatic clinical trial by the Patient-Centered Outcomes Research Institute's National Patient-Centered Clinical Research Network, called the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing the Benefits and Long-term Effectiveness) trial.
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