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

  • Clinical Trials (J Butler, Section Editor)
  • Published:
Current Heart Failure Reports Aims and scope Submit manuscript

Abstract

Purpose of Review

There are over 25 million patients living with heart failure globally. Overall, and especially post-discharge, clinical outcomes have remained poor in heart failure despite multiple trials, with both successes and failures over the last two decades. Matching therapies to the right patient population, identifying high-quality sites, and ensuring optimal trial design and execution represent important considerations in the development of novel therapeutics in this space.

Recent Findings

While clinical trials have undergone rapid globalization, this has come with regional variation in comorbidities, clinical parameters, and even clinical outcomes and treatment effects across international sites.

Summary

These issues have now highlighted knowledge gaps about the conduct of trials, selection of study sites, and an unmet need to develop and identify “ideal” sites. There is a need for all stakeholders, including academia, investigators, healthcare organizations, patient advocacy groups, industry sponsors, research organizations, and regulatory authorities, to work as a multidisciplinary group to address these problems and develop practical solutions to improve trial conduct, efficiency, and execution. We review these trial-level issues using examples from contemporary studies to inform and optimize the design of future global clinical trials in heart failure.

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Abbreviations

HF:

Heart failure

References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

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Authors and Affiliations

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

    Chaudhry M. S. Sarwar & Javed Butler

  2. Brigham and Women’s Hospital Heart and Vascular Center, Boston, MA, USA

    Muthiah Vaduganathan

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  1. Chaudhry M. S. Sarwar
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  2. Muthiah Vaduganathan
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  3. Javed Butler
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Correspondence to Javed Butler.

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Conflict of Interest

Chaudhry MS Sarwar and Muthiah Vaduganathan declare no conflicts of interest.

Javed Butler reports receiving research support from the National Institutes of Health, and European Union, and serves as a consultant to Amgen, Bayer, Boehringer Ingelheim, Cardiocell, Celladon, Novartis, Trevena, Relypsa, Z Pharma, and Zensun.

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This article does not contain any studies with human or animal subjects performed by any of the authors.

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This article is part of the Topical Collection on Clinical Trials

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Sarwar, C.M.S., Vaduganathan, M. & Butler, J. Impact of Site Selection and Study Conduct on Outcomes in Global Clinical Trials. Curr Heart Fail Rep 14, 203–209 (2017). https://doi.org/10.1007/s11897-017-0335-y

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