Statistical documentation for multi-disease, multi-domain platform trials : our experience with the Staphylococcus aureus Network Adaptive Platform trial
(2025) In Trials 26(1).- Abstract
Platform trials have become widely adopted across multiple disease areas over recent years, however, guidelines for operationalising these trials have not kept pace. We outline a series of documents that summarise the statistical components, and implicit processes, of the Staphylococcus aureus Network Adaptive Platform (SNAP) trial to provide an informal template for other researchers and reviewers of platform trials. We briefly summarise the content and role of the core protocol, statistical appendix, domain-specific appendices, simulation report, statistical implementation guides, data safety and monitoring committee (DSMC) reports, and domain-specific statistical analysis plans and final reports, and a transparent governance... (More)
Platform trials have become widely adopted across multiple disease areas over recent years, however, guidelines for operationalising these trials have not kept pace. We outline a series of documents that summarise the statistical components, and implicit processes, of the Staphylococcus aureus Network Adaptive Platform (SNAP) trial to provide an informal template for other researchers and reviewers of platform trials. We briefly summarise the content and role of the core protocol, statistical appendix, domain-specific appendices, simulation report, statistical implementation guides, data safety and monitoring committee (DSMC) reports, and domain-specific statistical analysis plans and final reports, and a transparent governance structure that ensures separate blinded and unblinded statistical teams. In the absence of guidelines or checklists for platform trial statistical documents, we hope to provide useful guidance to others in terms of what has worked so far for the SNAP trial, stimulate discussion, and inform a future consensus. Trial registrationNCT05137119. Registered on 30 November 2021.
(Less)
- author
- Mahar, Robert K.
; McGlothlin, Anna
; Dymock, Michael
; Barina, Lauren
; Bonten, Marc
; Bowen, Asha
; Cheng, Matthew P.
; Daneman, Nick
; Goodman, Anna L.
; Lee, Todd C.
; Lewis, Roger J.
; Lumley, Thomas
; McLean, Alistair R.D.
; McQuilten, Zoe
; Mora, Jocelyn
; Paterson, David L.
; Price, David J.
; Roberts, Jason
; Snelling, Tom
; Tverring, Jonas
LU
; Webb, Steve A.
; Yahav, Dafna
; Davis, Joshua S.
; Tong, Steven Y.C.
and Marsh, Julie A.
(Less) - author collaboration
- organization
- publishing date
- 2025
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Trials
- volume
- 26
- issue
- 1
- article number
- 49
- publisher
- BioMed Central (BMC)
- external identifiers
-
- pmid:39934879
- scopus:85218417661
- ISSN
- 1745-6215
- DOI
- 10.1186/s13063-024-08684-8
- language
- English
- LU publication?
- yes
- id
- 659912dd-b0fb-4f61-9182-d428a7a7dbe5
- date added to LUP
- 2025-06-10 10:08:46
- date last changed
- 2025-07-08 13:44:24
@misc{659912dd-b0fb-4f61-9182-d428a7a7dbe5,
abstract = {{<p>Platform trials have become widely adopted across multiple disease areas over recent years, however, guidelines for operationalising these trials have not kept pace. We outline a series of documents that summarise the statistical components, and implicit processes, of the Staphylococcus aureus Network Adaptive Platform (SNAP) trial to provide an informal template for other researchers and reviewers of platform trials. We briefly summarise the content and role of the core protocol, statistical appendix, domain-specific appendices, simulation report, statistical implementation guides, data safety and monitoring committee (DSMC) reports, and domain-specific statistical analysis plans and final reports, and a transparent governance structure that ensures separate blinded and unblinded statistical teams. In the absence of guidelines or checklists for platform trial statistical documents, we hope to provide useful guidance to others in terms of what has worked so far for the SNAP trial, stimulate discussion, and inform a future consensus. Trial registrationNCT05137119. Registered on 30 November 2021.</p>}},
author = {{Mahar, Robert K. and McGlothlin, Anna and Dymock, Michael and Barina, Lauren and Bonten, Marc and Bowen, Asha and Cheng, Matthew P. and Daneman, Nick and Goodman, Anna L. and Lee, Todd C. and Lewis, Roger J. and Lumley, Thomas and McLean, Alistair R.D. and McQuilten, Zoe and Mora, Jocelyn and Paterson, David L. and Price, David J. and Roberts, Jason and Snelling, Tom and Tverring, Jonas and Webb, Steve A. and Yahav, Dafna and Davis, Joshua S. and Tong, Steven Y.C. and Marsh, Julie A.}},
issn = {{1745-6215}},
language = {{eng}},
number = {{1}},
publisher = {{BioMed Central (BMC)}},
series = {{Trials}},
title = {{Statistical documentation for multi-disease, multi-domain platform trials : our experience with the Staphylococcus aureus Network Adaptive Platform trial}},
url = {{http://dx.doi.org/10.1186/s13063-024-08684-8}},
doi = {{10.1186/s13063-024-08684-8}},
volume = {{26}},
year = {{2025}},
}