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Improving public health by improving clinical trial guidelines and their application

Martin J Landray1, Jeroen J Bax2, Laurence Alliot3

  • 1Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.

European Heart Journal
|March 23, 2017
PubMed

Insights

Randomized controlled trials (RCTs) are crucial for cardiovascular therapeutics. Current large-scale RCTs face sustainability concerns, prompting a need for meaningful change in cardiovascular clinical research conduct.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Evidence-Based Medicine

Background:

  • Randomized controlled trials (RCTs) are fundamental to advancing cardiovascular therapeutics, guiding the adoption of effective treatments and avoidance of harmful interventions.
  • Cardiovascular research has evolved significantly, with modern RCTs requiring large patient cohorts, multiple international sites, and substantial infrastructure.
  • Concerns exist regarding the sustainability of current large-scale RCT models, potentially hindering the evaluation of new and existing cardiovascular treatments.

Purpose of the Study:

  • To summarize key insights and discussions from the European Society of Cardiology Cardiovascular Roundtable meeting in October 2015 regarding the challenges in cardiovascular clinical research.
  • To highlight subsequent progress made in addressing these challenges.
  • To identify actionable next steps for improving the conduct of cardiovascular clinical research.

Main Methods:

  • The study is based on discussions and insights from a meeting involving patients, regulators, funders, and trialists.
  • Key issues concerning the current approach to cardiovascular clinical trials were considered.
  • The paper synthesizes these discussions to propose future directions.

Main Results:

  • The meeting identified significant concerns about the sustainability and efficiency of large, multi-center, international cardiovascular RCTs.
  • Progress has been made in addressing some of the identified challenges since the 2015 meeting.
  • Specific next steps for meaningful change in cardiovascular clinical research were outlined.

Conclusions:

  • The current model of large-scale cardiovascular RCTs faces sustainability challenges that may impede patient care.
  • Collaborative efforts involving all stakeholders are essential for implementing necessary changes in clinical trial conduct.
  • Continued progress and adaptation are vital for the future of effective cardiovascular clinical research.

Keywords:
Cardiovascular diseasesClinical trialsPragmatic clinical trialsRandomized controlled trials

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