Mahar, Robert K. http://orcid.org/0000-0002-3643-923X
McGlothlin, Anna
Dymock, Michael
Lee, Todd C.
Lewis, Roger J.
Lumley, Thomas
Mora, Jocelyn
Price, David J.
Saville, Benjamin R.
Snelling, Tom
Turner, Rebecca
Webb, Steven A.
Davis, Joshua S.
Tong, Steven Y. C.
Marsh, Julie A.
Bowen, Asha
Cheng, Matthew
Daneman, Nick
Davis, Joshua
Goodman, Anna
Heriot, George
Lee, Todd C.
Lewis, Roger
Lye, David
Marsh, Julie
McGlothlin, Anna
McQuilten, Zoe
Mora, Jocelyn
Morpeth, Susan
Paterson, David
Price, David
Roberts, Jason
Robinson, Owen
Scarborough, Matthew
Tong, Steven
van Hal, Sebastiaan
Walls, Genevieve
Webb, Steve
Whiteway, Lynda
Yahav, Dafna
,
Funding for this research was provided by:
National Health and Medical Research Council (1184238, 2014900)
Canadian Institutes of Health Research (451092)
Health Research Council of New Zealand (20/344)
Athlae Lyon/Starship Foundation Trust (ASF2144_WEBB)
National Medical Research Council (CTGIIT21nov-0002)
United Kingdom National Institute for Health Research (NIHR133719)
Medical Research Council (MC_UU_00004/07)
Article History
Received: 10 May 2023
Accepted: 5 October 2023
First Online: 6 December 2023
Declarations
:
: The SNAP trial was initially approved by an Australian human research ethics committee (HREC Reference Number: HREC/74098/MH-2021). Ethical approval is sought from a properly constituted and accredited human research ethics committee (HREC) or institutional review board (IRB) for all trial sites. Where possible, a single lead committee will provide approval for all sites under its purview. Local site-specific approvals will also be sought where required by local regulations. Written informed consent is obtained from all participants or their surrogate decision makers prior to entry into the platform.
: Not applicable.
: 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.