Statistical documentation for multi-disease, multi-domain platform trials: our experience with the Staphylococcus aureus Network Adaptive Platform trial.

Statistical documentation for multi-disease, multi-domain platform trials: our experience with the Staphylococcus aureus Network Adaptive Platform trial.

Publication date: Feb 11, 2025

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 registration NCT05137119 . Registered on 30 November 2021.

Open Access PDF

Concepts Keywords
Checklists Adaptive
Disease Aureus
Nct05137119 Documents
November Domain
Staphylococcus Guidelines
Multi
Network
Provide
Snap
Specific
Staphylococcus
Statistical
Summarise
Trial
Trials

Semantics

Type Source Name
disease IDO role
pathway REACTOME Reproduction
disease MESH COVID 19 pandemic
disease IDO algorithm
drug DRUGBANK Ranitidine
disease MESH Pneumonia
drug DRUGBANK Coenzyme M
disease MESH confusion
drug DRUGBANK Sodium hydroxide
disease MESH graft versus host disease
disease MESH infections
disease IDO cell
drug DRUGBANK Huperzine B
disease MESH Infectious Diseases
disease IDO infection
drug DRUGBANK Trestolone
disease MESH Emergency
drug DRUGBANK Clindamycin
disease MESH bacteremia

Original Article

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