Evidence map›Paper›PMID 39017997›Full record

ReviewInfection2024

Innovative approaches for vaccine trials as a key component of pandemic preparedness - a white paper.

Ullrich Bethe, Zoi D Pana, Christian Drosten, Herman Goossens, Franz König, Arnaud Marchant, Geert Molenberghs, Martin Posch, Pierre Van Damme, Oliver A Cornely

Abstract readReviewConsensus Statement
In one paragraph

Review in Infection, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
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

10 authors.

Ullrich Bethe *Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Faculty of Medicine and University Hospital Cologne, University of Cologne, Herderstrasse 52, 50931, Cologne, Germany.ORCID http://orcid.org/0000-0001-9979-1671
Zoi D Pana *Medical School, European University of Cyprus, Nicosia, Cyprus.ORCID http://orcid.org/0000-0002-5893-1081
Christian DrostenInstitute of Virology, Charité Universitätsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0001-7923-0519
Herman GoossensLaboratory of Medical Microbiology, Vaccine & Infectious Disease Institute and Biobank Antwerp, University of Antwerp, Wilrijk, Belgium.ORCID http://orcid.org/0000-0003-4891-4031
Franz KönigCenter for Medical Data Science, Institute of Medical Statistics, Medical University of Vienna, Vienna, Austria.ORCID http://orcid.org/0000-0002-6893-3304
Arnaud MarchantEuropean Plotkin Institute for Vaccinology, Université libre de Bruxelles, Brussels, Belgium.ORCID http://orcid.org/0000-0002-0007-382X
Geert MolenberghsInteruniversity Institute for Biostatistics and Statistical Bioinformatics, Data Science Institute, KU Leuven and Hasselt University, Wilrijk, Belgium.ORCID http://orcid.org/0000-0002-6453-5448
Martin PoschCenter for Medical Data Science, Institute of Medical Statistics, Medical University of Vienna, Vienna, Austria.ORCID http://orcid.org/0000-0001-8499-8573
Pierre Van DammeCentre for the Evaluation of Vaccination, VACCINOPOLIS, Vaccine and Infectious Disease Institute, University of Antwerp, Wilrijk, Belgium.ORCID http://orcid.org/0000-0002-8642-1249
Oliver A CornelyInstitute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Faculty of Medicine and University Hospital Cologne, University of Cologne, Herderstrasse 52, 50931, Cologne, Germany. oliver.cornely@uk-koeln.de.ORCID http://orcid.org/0000-0001-9599-3137

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWHO postulates the application of adaptive design features in the global clinical trial ecosystem. However, the adaptive platform trial (APT) methodology has not been widely adopted in clinical research on vaccines.

methodsThe VACCELERATE Consortium organized a two-day workshop to discuss the applicability of APT methodology in vaccine trials under non-pandemic as well as pandemic conditions. Core aspects of the discussions are summarized in this article.

resultsAn "ever-warm" APT appears ideally suited to improve efficiency and speed of vaccine research. Continuous learning based on accumulating APT trial data allows for pre-planned adaptations during its course. Given the relative design complexity, alignment of all stakeholders at all stages of an APT is central. Vaccine trial modelling is crucial, both before and in a pandemic emergency. Various inferential paradigms are possible (frequentist, likelihood, or Bayesian). The focus in the interpandemic interval may be on research gaps left by industry trials. For activation in emergency, template Disease X protocols of syndromal design for pathogens yet unknown need to be stockpiled and updated regularly. Governance of a vaccine APT should be fully integrated into supranational pandemic response mechanisms. DISCUSSION: A broad range of adaptive features can be applied in platform trials on vaccines. Faster knowledge generation comes with increased complexity of trial design. Design complexity should not preclude simple execution at trial sites. Continuously generated evidence represents a return on investment that will garner societal support for sustainable funding. Adaptive design features will naturally find their way into platform trials on vaccines.

Indexed as

Clinical Trials as TopicPandemicsAdaptive Clinical Trials as TopicCOVID-19HumansPandemic PreparednessResearch DesignVaccinesVaccinesAdaptive platform trialBayesianConcurrent controlsEnrichmentFrequentistInterpandemic intervalModelling pandemic preparednessPreventionRandomized clinical trialResponse-adaptive randomizationSimulationStakeholdersTrial designVACCELERATEVaccines

Identifiers

PMID39017997
PMCPMC11621139

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.