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.

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