Evidence map›Paper›PMID 39540114›Full record

ReviewJournal of clinical and translational science2024

ACTIV trials: cross-trial lessons learned for master protocol implementation.

Maryam Keshtkar-Jahromi, Stacey J Adam, Indira Brar, Lucy K Chung, Judith S Currier, Eric S Daar, Victoria J Davey, Eileen T Denning, Annetine C Gelijns, Elizabeth S Higgs 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. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
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.
Stacey J AdamFoundation for the National Institutes of Health, North Bethesda, MD, USA.ORCID https://orcid.org/0000-0002-4590-5175
Indira BrarHenry Ford Health, Detroit, MI, USA.
Lucy K ChungCAMRIS International (under Contract No. 75N93019D00025) with National Institute of Allergy and Infectious Diseases, NIH, DHHS, Bethesd, MD, USA.
Judith S CurrierJSC Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
Eric S DaarDivision of HIV Medicine, Lundquist Institute at Harbor- University of California Los Angeles Medical Center, Torrance, CA, USA.
Victoria J DaveyOffice of Research and Development, US Department of Veterans Affairs, Washington, DC, USA.
Eileen T DenningDivision of Biostatistics & Health Data Science, University of Minnesota School of Public Health, Minneapolis, MN, USA.
Annetine C GelijnsPopulation Health Science and Policy, Mount Sinai, New York, NY, USA.
Elizabeth S HiggsDivision of Clinical Research, National Institute of Allergy and Infectious Diseases, Department of Health and Human Services, National Institutes of Health, Rockville, MD, USA.
Prasanna JagannathanStanford University, Stanford, CA, USA.
Arzhang Cyrus JavanNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.
Tomas O JensenCentre of Excellence for Health, Immunity, and Infections, Rigshospitalet, University of Copenhagen, Kobenhavn, Denmark.ORCID https://orcid.org/0000-0003-0398-4431
Nikolaus JilgDivision of Infectious Diseases, Massachusetts General Hospital, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Ioannis Kalomenidis1st Department of Critical Care and Pulmonary Medicine, National and Kapodistrian University of Athens School of Medicine, Evangelismos Hospital, Athens, Greece.
Peter KimNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.
Seema U NayakDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.
Matthew NewellGlobal Health & Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill, CA, USA.
Babafemi O TaiwoNorthwestern University, Evanston, IL, USA.
Tammy YokumDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.
Yvette DelphAxle Informatics, North Bethesda, MD, USA.

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
NIAID NIH HHS UM1 AI069424
6 · The paper itself

Abstract

The United States Government (USG) public-private partnership "Accelerating COVID-19 Treatment Interventions and Vaccines" (ACTIV) was launched to identify safe, effective therapeutics to treat patients with Coronavirus Disease 2019 (COVID-19) and prevent hospitalization, progression of disease, and death. Eleven original master protocols were developed by ACTIV, and thirty-seven therapeutic agents entered evaluation for treatment benefit. Challenges encountered during trial implementation led to innovations enabling initiation and enrollment of over 26,000 participants in the trials. While only two ACTIV trials continue to enroll, the recommendations here reflect information from all the trials as of May 2023. We review clinical trial implementation challenges and corresponding lessons learned to inform future therapeutic clinical trials implemented in response to a public health emergency and the conduct of complex clinical trials during "peacetime," as well.

Indexed as

Accelerating COVID-19 Treatment Interventions and Vaccinesclinical trial implementationCOVID-19master protocolpreparednesstrial platform

Identifiers

PMID39540114
PMCPMC11557279

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.