The statistical design and analysis of pandemic platform trials: Implications for the future

The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Cross-Trial Statistics Group gathered lessons learned from statisticians responsible for the design and analysis of the 11 ACTIV therapeutic master protocols to inform contemporary trial design as well as preparation for a future pandemic. The ACTIV master protocols were designed to rapidly assess what treatments might save lives, keep people out of the hospital, and help them feel better faster. Study teams initially worked without knowledge of the natural history of disease and thus without key information for design decisions. Moreover, the science of platform trial design was in its infancy. Here, we discuss the statistical design choices made and the adaptations forced by the changing pandemic context. Lessons around critical aspects of trial design are summarized, and recommendations are made for the organization of master protocols in the future.

Authors

Institutions

Publication Details

Journal
UNC Libraries
Published
2024-12-03
DOI
https://doi.org/10.17615/3zn4-dt76
Primary Topic
Advanced Causal Inference Techniques
Type
article
Field-Weighted Citation Impact
0.00

Funders

Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

The statistical design and analysis of pandemic platform trials: Implications for the future

Erica Brittain, Nancy L. Geller, Matthew S. Shotwell, Michael A. Proschan et al.
UNC Libraries
Advanced Causal Inference Techniques
article

The statistical design and analysis of pandemic platform trials: Implications for the future

Erica Brittain, Nancy L. Geller, Matthew S. Shotwell, Michael A. Proschan, Scott M. Berry, Lisa M. LaVange, Prasanna Jagannathan, Мухамедьярова А.Б., Birgit Grund, Shaji Thomas, Giota Touloumi, Eric Leifer, Leningrad Fh A N K-K A M E N E T Z K I J, Aarav Kannan J, Telisa Stewart, Hughes M.D., Price K.L, Harrell F.E
article en

Abstract

The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Cross-Trial Statistics Group gathered lessons learned from statisticians responsible for the design and analysis of the 11 ACTIV therapeutic master protocols to inform contemporary trial design as well as preparation for a future pandemic. The ACTIV master protocols were designed to rapidly assess what treatments might save lives, keep people out of the hospital, and help them feel better faster. Study teams initially worked without knowledge of the natural history of disease and thus without key information for design decisions. Moreover, the science of platform trial design was in its infancy. Here, we discuss the statistical design choices made and the adaptations forced by the changing pandemic context. Lessons around critical aspects of trial design are summarized, and recommendations are made for the organization of master protocols in the future.

UNC Libraries
University of North Carolina at Chapel Hill (US)
Eli Lilly and Company
Good health and well-being
Openalex Percentile: Top 77%
Advanced Causal Inference Techniques
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.