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

Details

Serval ID
serval:BIB_66F8BD6083FA
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Designing phase III or IV trials for vaccines: choosing between individual or cluster randomised trial designs.
Journal
Vaccine
Author(s)
Vaucher P.
ISSN
0264-410X (Print)
ISSN-L
0264-410X
Publication state
Published
Issued date
2009
Peer-reviewed
Oui
Volume
27
Number
13
Pages
1928-1931
Language
english
Notes
Publication types: Journal Article
Abstract
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.
Keywords
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
Create date
09/01/2015 15:58
Last modification date
20/08/2019 14:22
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