Designing phase III or IV trials for vaccines: choosing between individual or cluster randomised trial designs.

Détails

ID Serval
serval:BIB_66F8BD6083FA
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Designing phase III or IV trials for vaccines: choosing between individual or cluster randomised trial designs.
Périodique
Vaccine
Auteur⸱e⸱s
Vaucher P.
ISSN
0264-410X (Print)
ISSN-L
0264-410X
Statut éditorial
Publié
Date de publication
2009
Peer-reviewed
Oui
Volume
27
Numéro
13
Pages
1928-1931
Langue
anglais
Notes
Publication types: Journal Article
Résumé
The choice of design between individual randomisation, cluster or pseudo-cluster randomisation is often made difficult. Clear methodological guidelines have been given for trials in general practice, but not for vaccine trials. This article proposes a decisional flow-chart to choose the most adapted design for evaluating the effectiveness of a vaccine in large-scale studies. Six criteria have been identified: importance of herd immunity or herd protection, ability to delimit epidemiological units, homogeneity of transmission probability across sub-populations, population's acceptability of randomisation, availability of logistical resources, and estimated sample size. This easy to use decisional method could help sponsors, trial steering committees and ethical committees adopt the most suitable design.
Mots-clé
Clinical Trials, Phase III as Topic/methods, Clinical Trials, Phase IV as Topic/methods, Cluster Analysis, Disease Transmission, Infectious, Epidemiology, Humans, Immunity, Herd, Patient Selection, Randomized Controlled Trials as Topic/methods, Research Design, Sample Size, Vaccines
Pubmed
Web of science
Création de la notice
09/01/2015 16:58
Dernière modification de la notice
02/03/2024 8:09
Données d'usage