Evidence map›Paper›PMID 39478775›Full record

ReviewJournal of clinical and translational science2024

ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic.

Maryam Keshtkar-Jahromi, Kevin J Anstrom, Christina Barkauskas, Samuel M Brown, Eric S Daar, William Fischer, Kevin W Gibbs, Elizabeth S Higgs, Michael D Hughes, Prasanna Jagannathan and 11 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review 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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Maryam Keshtkar-JahromiDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.
Kevin J AnstromGillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Christina BarkauskasDuke Clinical Research Institute, Duke University, Durham, NC, USA.
Samuel M BrownPulmonary and Critical Care Medicine, Intermountain, Salt Lake City, UT, USA.
Eric S DaarDivision of HIV Medicine, Lundquist Institute at Harbor- University of California Los Angeles Medical Center, Los Angeles, CA, USA.
William FischerDivision of Pulmonary Diseases and Critical Care Medicine, University of North Carolina at Chapel Hill, Salt Lake City, UT, USA.
Kevin W GibbsWake Forest University School of Medicine, Winston-Salem, NC, USA.
Elizabeth S HiggsDivision of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Michael D HughesDepartment of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA.
Prasanna JagannathanStanford University, Stanford, CA, USA.
Lisa LaVangeDepartment of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Christopher J LindsellDepartment of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.ORCID https://orcid.org/0000-0002-3297-2811
Seema U NayakDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.
Roger ParedesDepartment of Infectious Diseases, Hospital Germans Trias and irsiCaixa, Badalona, Spain.
Mahesh ParmarMedical Research Council Clinical Trials Unit, University College of London, London, WC, UK.
Ithan D PeltanDepartment of Pulmonary and Critical Care Medicine, Intermountain, Salt Lake City, UT, USA.
Michael ProschanNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.
Matthew S ShotwellVanderbilt University, Nashville, USA.
David M VockDivision of Biostatistics & Health Data Science, School of Public Health, University of Minnesota, Minneapolis, MN, USA.
Tammy YokumNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.
Stacey J AdamFoundation for the National Institutes of Health, North Bethesda, MD, USA.ORCID https://orcid.org/0000-0002-4590-5175

Funding

UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
Measuring and Learning from Care Variation in SepsisR35GM151147 · NIGMS · IHC HEALTH SERVICES, INC. · PI Ithan Daniel Peltan · 2023 to 2026
$1.5M
NIAID NIH HHS UM1 AI069424NIGMS NIH HHS R35 GM151147
6 · The paper itself

Abstract

Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) was initiated by the US government to rapidly develop and test vaccines and therapeutics against COVID-19 in 2020. The ACTIV Therapeutics-Clinical Working Group selected ACTIV trial teams and clinical networks to expeditiously develop and launch master protocols based on therapeutic targets and patient populations. The suite of clinical trials was designed to collectively inform therapeutic care for COVID-19 outpatient, inpatient, and intensive care populations globally. In this report, we highlight challenges, strategies, and solutions around clinical protocol development and regulatory approval to document our experience and propose plans for future similar healthcare emergencies.

Indexed as

ACTIVclinical trialCOVID-19designlessons

Identifiers

PMID39478775
PMCPMC11523015

What OpenQuestion 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 OpenQuestion graph.