@article{2cb4d1e60d954a2d8db0a92466fb0b07,
title = "A blueprint for a multi-disease, multi-domain Bayesian adaptive platform trial incorporating adult and paediatric subgroups: the Staphylococcus aureus Network Adaptive Platform trial",
abstract = "The Staphylococcus aureus Network Adaptive Platform (SNAP) trial is a multifactorial Bayesian adaptive platform trial that aims to improve the way that S. aureus bloodstream infection, a globally common and severe infectious disease, is treated. In a world first, the SNAP trial will simultaneously investigate the effects of multiple intervention modalities within multiple groups of participants with different forms of S. aureus bloodstream infection. Here, we formalise the trial structure, modelling approach, and decision rules that will be used for the SNAP trial. By summarising the statistical principles governing the design, our hope is that the SNAP trial will serve as an adaptable template that can be used to improve comparative effectiveness research efficiency in other disease areas. Trial registration NCT05137119 . Registered on 30 November 2021.",
keywords = "Adaptive, Bayesian, Platform, Randomised, Staphylococcus aureus, Trial",
author = "Mahar, {Robert K.} and Anna McGlothlin and Michael Dymock and Lee, {Todd C.} and Lewis, {Roger J.} and Thomas Lumley and Jocelyn Mora and Price, {David J.} and Saville, {Benjamin R.} and Tom Snelling and Rebecca Turner and Webb, {Steven A.} and Davis, {Joshua S.} and Tong, {Steven Y. C} and Marsh, {Julie A.}",
note = "Funding Information: This work is supported by the Australian National Health and Medical Research Council (NHMRC) (1184238, 2014900), the Medical Research Future Fund (2017301), the Canadian Institutes of Health Research (451092), the Health Research Council of New Zealand (20/344), the Athlae Lyon/Starship Foundation Trust (ASF2144_WEBB), the National Medical Research Council (CTGIIT21nov-0002), and the United Kingdom National Institute for Health Research (NIHR133719). Rebecca Turner was supported by the UK Medical Research Council (Programme MC_UU_00004/07). This study/project is funded by the NIHR [NIHR133719]. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Funding Information: Anna McGlothlin is an employee of Berry Consultants LLC, in which capacity she is contracted as a consultant to numerous pharmaceutical and device companies on topics of statistical modelling and trial design, and reports grants and contracts unrelated to this work and consulting fees from Berry Consultants LLC. Todd C. Lee reports research salary support from Fonds de Recherche Quebec-Sante, operating funds for other studies including CATCO from the CIHR; and operating funds for other studies from the McGill Interdisciplinary Institute Infection and Immunity. Roger J. Lewis is an employee of Berry Consultants, LLC, a statistical consulting firm that specialises in the design of adaptive and platform clinical trials. Berry Consultants received compensation for work included in the content of the submission. Steven Y. C. Tong reports a contract as a paid consultant for advice on clinical trial design, and consulting fees from Roivant Sciences as a paid consultant for advice on clinical trial design. Steve A. Webb reports personal consulting fees from ClinicIQ pharma and Roche; an unpaid role as chair of Australian Clinical Trials Alliance; and stock and options with ClinicIQ. All other authors report no potential conflicts. Publisher Copyright: {\textcopyright} 2023, The Author(s).",
year = "2023",
month = dec,
doi = "10.1186/s13063-023-07718-x",
language = "English",
volume = "24",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",
}
