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Authors
Manyara, Anthony Muchai
Stewart, Derek
Markham, Sarah
Worrall, Andrew
Harris, Ray
Davies, Philippa
Weir, Christopher J.
Young, Amber E.
Blazeby, Jane
Butcher, Nancy J.
Bujkiewicz, Sylwia
Chan, An-Wen
Dawoud, Dalia
Offringa, Martin
Ouwens, Mario
Collins, Gary S.
Ross, Joseph S.
Taylor, Rod S.
Ciani, Oriana
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Funding
Funding for this research was provided by:
NIHR Bristol Biomedical Research centre
Leicester NIHR Biomedical Research Centre
Cancer Research UK (C49297/A27294)
Medical Research Council (MR/V038400/1)
Medical Research Council (MR/V038400/1)
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Article History
Received: 17 October 2024
Accepted: 24 October 2025
First Online: 4 December 2025
Declarations
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: The SPIRIT- and CONSORT-Surrogate project received ethical approval on 24th May 2022 from the University of Glasgow College of Medical, Veterinary, and Life Sciences Ethics Committee (Project No: 200210151). All PPIE partners consented to participate in project activities.
: Not applicable.
: Sylwia Bujkiewicz is a member of the NICE Decision Support Unit (DSU) and NICE Guidelines Technical Support Unit (TSU), has served as a paid consultant, providing methodological advice, to NICE, Roche, IQVIA and RTI Health Solutions, received payments for educational events from Roche and has received research funding from European Federation of Pharmaceutical Industries & Associations (EEPIA) and Johnson & Johnson. Mario Ouwens works for and has shares in AstraZeneca. Joseph Ross is a Deputy Editor at JAMA, was formerly an Associate Editor at BMJ, and is co-founder (unpaid) of medRxiv; he has received research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644), and from Arnold Ventures and was an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. that was settled in September 2022. Nancy Butcher has received consulting fees from Nobias Therapeutics, Inc. Oriana Ciani is an Associate Editor for Value in Health and has received consulting fees from MSD and Janssen. Ray Harris has shares in Johnson and Johnson.
