Developing Guidance for Donor Intervention Randomized Controlled Trials: Initial Discussions From the Canada-United Kingdom 2022 Workshop.

Autor:	Slessarev M; Department of Medicine, Western University, London, ON, Canada.; The Canadian Donation and Transplantation Research Program, Edmonton, AB, Canada.; Ontario Health (Trillium Gift of Life Network), Toronto, ON, Canada., Bain KL; The Canadian Donation and Transplantation Research Program, Edmonton, AB, Canada., Basmaji J; Department of Medicine, Western University, London, ON, Canada., Blydt-Hansen TD; Department of Pediatrics (Nephrology), University of British Columbia, Vancouver, BC, Canada., Cooper J; Department of Health Services Research and Management, School of Health & Psychological Sciences, City, University of London, London, United Kingdom., D'Aragon F; Department of Anesthesiology, Université de Sherbrooke, Sherbrooke, QC, Canada.; Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada., Del Sorbo L; Interdepartmental Division of Critical Care Medicine, University Health Network, University of Toronto, Toronto, ON, Canada., Evans A; NHS Blood and Transplant, Clinical Trials Unit, Bristol, United Kingdom., Gordon AC; Division of Anaesthetics, Pain Medicine and Intensive Care, Imperial College London, London United Kingdom., Klein G; Centre for Clinical Trial Support, Sunnybrook Research Institute, Toronto, ON, Canada., Meade MO; Department of Medicine, McMaster University, Hamilton, ON, Canada., Murphy N; Department of Medicine, Western University, London, ON, Canada.; The Canadian Donation and Transplantation Research Program, Edmonton, AB, Canada.; Department of Philosophy, Western University, London, ON, Canada., Thomas HL; NHS Blood and Transplant, Clinical Trials Unit, Bristol, United Kingdom., Weiss MJ; The Canadian Donation and Transplantation Research Program, Edmonton, AB, Canada.; Transplant Québec, Montréal, QC, Canada.; Division of Critical Care, Department of Pediatrics, Centre Mère-Enfant Soleil du CHU de Québec, Québec, QC, Canada., Weijer C; Department of Medicine, Western University, London, ON, Canada.; Department of Philosophy, Western University, London, ON, Canada.; Department of Epidemiology & Biostatistics, Western University, London, ON, Canada., Harvey D; NHS Blood and Transplant, University of Nottingham, Nottingham, United Kingdom.
Jazyk:	angličtina
Zdroj:	Transplantation [Transplantation] 2024 Aug 01; Vol. 108 (8), pp. 1776-1781. Date of Electronic Publication: 2024 Jul 20.
DOI:	10.1097/TP.0000000000004983
Abstrakt:	Background: Donor interventions, including medications, protocols, and medical devices administered to donors, can enhance transplantable organ quality and quantity and maximize transplantation success. However, there is paucity of high-quality evidence about their effectiveness, in part because of ethical, practical, and regulatory challenges, and lack of guidance about conduct of donor intervention randomized controlled trials (RCTs). Methods: With the vision to develop authoritative guidance for conduct of donor intervention RCTs, we convened a workshop of Canadian-United Kingdom experts in organ donation and transplantation ethics, research, and policy to identify stakeholders, explore unique challenges, and develop research agenda to inform future work in this promising field. Results: Donor intervention trials should consider perspectives of broad group of stakeholders including donors, transplant recipients, and their families; researchers in donation and transplantation; research ethics boards; and healthcare providers and administrators involved in donation and transplantation. Unique challenges include (1) research ethics (living versus deceased status of the donor at the time of intervention, intervention versus outcomes assessment in different individuals, harm-benefit analysis in donors versus recipients, consent, and impact on research bystanders); (2) outcome data standardization and linkage; and (3) regulatory and governance considerations. Conclusions: Donor intervention RCTs hold potential to benefit organ transplantation outcomes but face unique research ethics, outcome data, and regulatory challenges. By developing research agenda to address these challenges, our workshop was an important first step toward developing Canada-United Kingdom guidance for donor intervention RCTs that are poised to improve the quality and availability of transplantable organs. (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
Databáze:	MEDLINE
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