A guide to implementation science for Phase 3 clinical trialists : designing trials for evidence uptake

dc.contributor.authorVan Spall, Harriette G.C.
dc.contributor.authorDesveaux, Laura
dc.contributor.authorFinch, Tracy
dc.contributor.authorLewis, Cara C.
dc.contributor.authorMensah, George A.
dc.contributor.authorRosenberg, Yves
dc.contributor.authorSingh, Kavita
dc.contributor.authorVenter, Francois
dc.contributor.authorWeiner, Bryan J.
dc.contributor.authorZannad, Faiez
dc.date.accessioned2025-09-08T11:37:43Z
dc.date.issued2024-11
dc.descriptionThis paper was generated, in part, from discussions at the 20th Global Cardiovascular Clinical Trialists (CVCT) Forum held in December 2023.
dc.description.abstractThe delayed and modest uptake of evidence-based treatments following cardiovascular clinical trials highlights the need for greater attention to implementation early in the development and testing of treatments. However, implementation science is not well understood and is often an afterthought following phase 3 trials. In this review, we describe the goals, frameworks, and methods of implementation science, along with common multilevel barriers and facilitators of implementation. We propose that some of the approaches used for implementation well after a trial has ended can be incorporated into the design of phase 3 trials to foster early post-trial implementation. Approaches include, but are not limited to, engaging broad stakeholders including patients, clinicians, and decision-makers in trial advisory boards; using less restrictive eligibility criteria that ensure both internal validity and generalizability; having trial protocols reviewed by regulators; integrating trial execution with the health care system; evaluating and addressing barriers and facilitators to deployment of the intervention; and undertaking cost-effectiveness and cost utility analyses across jurisdictions. We provide case examples to highlight concepts and to guide end-of-trial implementation. HIGHLIGHTS • Cardiovascular disease remains inadequately treated, highlighting the need for greater attention to implementation science. • Trialists and clinicians could harness key principles of implementation science to foster better end-of-trial uptake. • Phase 3 trials could use less restrictive eligibility criteria, engage broad stakeholders in trial design, use existing health care systems to execute the trial, evaluate barriers and facilitators to implementation, and improve workflow processes within the trial. • When trial results are positive, trial sites could be engaged in early implementation research and deployment of the intervention.
dc.description.departmentSchool of Health Systems and Public Health (SHSPH)
dc.description.embargo2025-11-04
dc.description.sdgSDG-03: Good health and well-being
dc.description.sponsorshipDr Van Spall : Grants from the Canadian Institutes of Health Research (CIHR) and the Heart and Stroke Foundation (HSF) has institution educational accounts with Boehringer Ingelheim and Novartis; has received consulting fees from the Baim Institute for Clinical Research; has trial committee roles with Medtronic, CardioVascular Research Foundation, and the Colorado Prevention Center Clinical Research; and has received travel and/or meeting attendance support from CVCT. Drs Desveaux, Finch, and Singh : travel and/or meeting attendance support from CVCT. Dr Lewis: Royalties or licenses from Springer Publishing for Practical Implementation Science. Dr Venter: d Institutional grants from the Bill and Melinda Gates Foundation, SA Medical Research Council, National Institutes for Health, Unitaid, Foundation for Innovative New Diagnostics, Merck and the Children's Investment Fund Foundation, USAID, Merck, Johnson and Johnson, ViiV Healthcare, and Novo Nordisk; honoraria for educational events and advisory board participation from Gilead Sciences, ViiV Healthcare, Mylan/Viatris, Merck, Adcock-Ingram, Aspen, Abbott, Roche, Johnson and Johnson, Sanofi, Boehringer Ingelheim, Thermo-Fischer, and Virology Education; honorarium from the International National Institutes of Health HIV Data and Safety Monitoring Board; and drug donations from ViiV Healthcare, Merck, Johnson and Johnson, and Gilead Sciences for investigator-led clinical studies. Dr Zannad: Consulting fees from 89bio, Applied Therapeutics, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardior Pharmaceuticals, Cellprothera, Cereno Scientific, CEVA, CVRx, Merck, Novartis, Novo Nordisk, Owkin, Pfizer, and Servier; honoraria for lectures from Bayer, Boehringer Ingelheim, CEVA, CVRx, Merck, and Novartis; has received fees for participation on a data safety monitoring board or advisory board from Acceleron/Merck; and has equity interests in G3 Pharmaceuticals, Cereno Pharmaceuticals, Cardiorenal, Eshmoun Clinical Research, and CVCT. A
dc.description.urihttps://www.sciencedirect.com/journal/journal-of-the-american-college-of-cardiology
dc.identifier.citationVan Spall, H.G.C., Desveaux, L., Finch, T. et al. 2025, 'A guide to implementation science for Phase 3 clinical trialists: designing trials for evidence uptake', Journal of the American College of Cardiology, vol. 84, no. 20, pp. 2063-2072, doi : 10.1016/j.jacc.2024.08.068.
dc.identifier.issn0735-1097 (print)
dc.identifier.issn1558-3597 (online)
dc.identifier.other10.1016/j.jacc.2024.08.068
dc.identifier.urihttp://hdl.handle.net/2263/104247
dc.language.isoen
dc.publisherElsevier
dc.rights© 2024 by the American College of Cardiology Foundation. Published by Elsevier. . Notice : this is the author’s version of a work that was accepted for publication in Journal of the American College of Cardiology. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. A definitive version was subsequently published in Journal of the American College of Cardiology, vol. 84, no. 20, pp. 2063-2072, 2024, doi : 10.1016/j.jacc.2024.08.068.
dc.subjectClinical trials
dc.subjectConceptual framework
dc.subjectDe-implementation
dc.subjectImplementation science
dc.subjectTrial design
dc.subjectST-segment elevation myocardial infarction (STEMI)
dc.subjectRandomized controlled trial (RCT)
dc.subjectHeart failure
dc.subjectCardiovascular clinical trialists (CVCT)
dc.titleA guide to implementation science for Phase 3 clinical trialists : designing trials for evidence uptake
dc.typePostprint Article

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