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Impact of Site Selection and Study Conduct on Outcomes in Global Clinical Trials

Chaudhry M S Sarwar1, Muthiah Vaduganathan2, Javed Butler3

  • 1Cardiology Division, Health Sciences Center, Stony Brook University, T-16, Room 080 SUNY, Stony Brook, NY, 11794, USA.

Current Heart Failure Reports
|June 26, 2017
PubMed
Abstract

Insights

Global heart failure clinical trials face challenges with poor patient outcomes and regional variations. Improving trial design, site selection, and execution requires multidisciplinary collaboration for better therapeutic development.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Global Health

Background:

  • Over 25 million patients globally suffer from heart failure, with persistently poor clinical outcomes, particularly post-discharge.
  • Despite numerous clinical trials over two decades, successes and failures highlight challenges in heart failure therapeutics development.

Purpose of the Study:

  • To review critical issues in global heart failure clinical trial design, execution, and site selection.
  • To identify knowledge gaps and the unmet need for "ideal" clinical trial sites.
  • To inform optimization of future global heart failure trials.

Main Methods:

  • Review of contemporary heart failure studies.
  • Analysis of trial-level issues in globalized clinical research.
  • Examination of regional variations in comorbidities, clinical parameters, and outcomes.

Main Results:

  • Globalization of clinical trials has introduced significant regional variations impacting outcomes and treatment effects.
  • Challenges exist in selecting high-quality clinical trial sites and ensuring optimal trial conduct.
  • There is a critical need for multidisciplinary collaboration among all stakeholders.

Conclusions:

  • Addressing knowledge gaps in trial conduct and site selection is crucial for improving heart failure therapeutic development.
  • Practical solutions are needed to enhance the efficiency and execution of global heart failure trials.
  • Collaborative efforts are essential to optimize the design and outcomes of future international heart failure studies.
Keywords:
Clinical trialsGeographic variationHeart failureOutcomesSite selectionStudy design

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