• Critical care clinics · Oct 2023

    Review

    Designing and Implementing "Living and Breathing" Clinical Trials: An Overview and Lessons Learned from the COVID-19 Pandemic.

    • Christopher M Horvat, Andrew J King, and David T Huang.
    • UPMC Children's Hospital of Pittsburgh, Faculty Pavilion, 4401 Penn Avenue, Suite 0200, Pittsburgh, PA 15224, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, 3550 Terrace Street, 603A, Pittsburgh, PA 15261, USA. Electronic address: Christopher.horvat@chp.edu.
    • Crit Care Clin. 2023 Oct 1; 39 (4): 717732717-732.

    AbstractThe practice of medicine is characterized by uncertainty, and the findings of randomized clinical trials (RCTs) are meant to help curb that uncertainty. Traditional RCTs, however, have many limitations. To overcome some of these limitations, new trial paradigms rooted in the origins of evidence-based medicine are beginning to disrupt the traditional mold. These new designs recognize uncertainty permeates medical decision making and aim to capitalize on modern health system infrastructure to integrate investigation as a component of care delivery. This article provides an overview of "living, breathing" trials, including current state, anticipated developments, and areas of controversy.Copyright © 2023 Elsevier Inc. All rights reserved.

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