• Fabien Maldonado, Rafael Paez, Robert J Lentz, Ankush Ratwani, and Jonathan D Casey.
• Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN; Vanderbilt Interventional Pulmonary Research Laboratory; Vanderbilt Center for Bioethics and Society. Electronic address: fabien.maldonado@vumc.org.
• Chest. 2024 Nov 20.

AbstractThe advances in minimally invasive lung cancer diagnostics of the last decade have transformed patient care but have also raised important concerns about the regulatory processes used to approve new devices and the best way to generate data to support their use. Disruptive technologies, such as robotic bronchoscopy, have been widely adopted by interventional pulmonologists in the absence of robust data demonstrating improved patient outcomes. Comparative research is needed to inform patient care, but traditional methods of conducting clinical trials in which research teams operate separately from clinical teams are ill-suited to testing the safety and effectiveness of technologies being introduced on the market at unprecedented speed. Pragmatic clinical trials, which integrate trial procedures into routine clinical care, represent an appealing alternative approach for generating much-needed data to inform clinical care. In this manuscript we illustrate the advantages and disadvantages of these research paradigms using two recently completed randomized controlled trials in navigational bronchoscopy and highlight the barriers and facilitators to using pragmatic trials to address the gap in comparative effectiveness research: these include the need for increased clarity of research regulations for pragmatic trials, adequate federal and private funding for such research, and alignment of incentives between clinicians, researchers, regulators, and industry.Copyright © 2024. Published by Elsevier Inc.

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