Evidence map›Paper›PMID 39540110›Full record

ArticleJournal of clinical and translational science2024

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

Christopher J Lindsell, Matthew Shotwell, Kevin J Anstrom, Scott Berry, Erica Brittain, Frank E Harrell, Nancy Geller, Birgit Grund, Michael D Hughes, Prasanna Jagannathan and 8 more

Erratum issuedAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Christopher J LindsellDuke University, Durham, NC, USA.ORCID https://orcid.org/0000-0002-3297-2811
Matthew ShotwellVanderbilt University Medical Center, Nashville, TN, USA.
Kevin J AnstromUniversity of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Scott BerryBerry Consultants, Austin, TX, USA.
Erica BrittainNational Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Frank E HarrellVanderbilt University Medical Center, Nashville, TN, USA.
Nancy GellerNational Heart, Lung, and Blood Institute, Bethesda, MD, USA.
Birgit GrundUniversity of Minnesota, Minneapolis, MN, USA.
Michael D HughesHarvard T.H. Chan School of Public Health, Boston, MA, USA.
Prasanna JagannathanStanford University School of Medicine, Stanford, CA, USA.
Eric LeiferNational Heart, Lung, and Blood Institute, Bethesda, MD, USA.
Carlee B MoserHarvard T.H. Chan School of Public Health, Boston, MA, USA.
Karen L PriceEli Lilly and Company, Indianapolis, IN, USA.
Michael ProschanNational Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Thomas StewartUniversity of Virginia, Charlottesville, VA, USA.ORCID https://orcid.org/0000-0002-5138-0758
Sonia ThomasRTI, Raleigh, NC, USA.
Giota TouloumiNational and Kapodistrian University of Athens, Athens, Greece.
Lisa LaVangeUniversity of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Clinical trialspandemic preparednessplatform trialsresearch designstatistical analysis

Identifiers

PMID39540110
PMCPMC11557281

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.