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Record W2111628987 · doi:10.1016/j.vaccine.2014.04.022

Placebo use in vaccine trials: Recommendations of a WHO expert panel

2014· article· en· W2111628987 on OpenAlexaff
Annette Rid, Abha Saxena, Abdhullah H. Baqui, Anant Bhan, Julie E. Bines, Marie-Charlotte Bouësseau, Arthur L. Caplan, James Colgrove, Ames Dhai, Rita A. Gómez‐Díaz, Shane K. Green, Gagandeep Kang, Rosanna Lagos, Patricia Loh, Alex John London, Kim Mulholland, Pieter Neels, Punee Pitisuttithum, Samba Cor Sarr, Michael J. Selgelid, Mark Sheehan, Peter G. Smith

Bibliographic record

VenueVaccine · 2014
Typearticle
Languageen
FieldSocial Sciences
TopicVaccine Coverage and Hesitancy
Canadian institutionsSt. Michael's HospitalUniversity of Toronto
FundersEuropean CommissionWorld Health OrganizationMedical Research CouncilNational Institute for Health and Care ResearchBill and Melinda Gates Foundation
KeywordsMedicinePlaceboClinical trialPsychological interventionIntensive care medicinePublic healthVaccine efficacyClinical study designImmunologyVaccinationAlternative medicineInternal medicinePsychiatryPathology

Abstract

fetched live from OpenAlex

Vaccines are among the most cost-effective interventions against infectious diseases. Many candidate vaccines targeting neglected diseases in low- and middle-income countries are now progressing to large-scale clinical testing. However, controversy surrounds the appropriate design of vaccine trials and, in particular, the use of unvaccinated controls (with or without placebo) when an efficacious vaccine already exists. This paper specifies four situations in which placebo use may be acceptable, provided that the study question cannot be answered in an active-controlled trial design; the risks of delaying or foregoing an efficacious vaccine are mitigated; the risks of using a placebo control are justified by the social and public health value of the research; and the research is responsive to local health needs. The four situations are: (1) developing a locally affordable vaccine, (2) evaluating the local safety and efficacy of an existing vaccine, (3) testing a new vaccine when an existing vaccine is considered inappropriate for local use (e.g. based on epidemiologic or demographic factors), and (4) determining the local burden of disease.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.408
metaresearch head score (Gemma)0.403
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Commentary · Consensus signal: Commentary
Teacher disagreement score0.592
Threshold uncertainty score0.730

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.4080.403
Meta-epidemiology (narrow)0.0040.005
Meta-epidemiology (broad)0.0090.015
Bibliometrics0.0100.013
Science and technology studies0.0040.008
Scholarly communication0.0100.009
Open science0.0180.006
Research integrity0.0440.024
Insufficient payload (model declined to judge)0.0060.009

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.117
GPT teacher head0.366
Teacher spread0.249 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.

Study designNot applicable
DomainMethods
GenreCommentary

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations65
Published2014
Admission routes1
Has abstractyes

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