Designing phase III or IV trials for vaccines: choosing between individual or cluster randomised trial designs.
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.
University General Medicine Unit, University of Lausanne, Bugnon 44, 1011 Lausanne, Switzerland. paul.vaucher@gmail.com
Paul
P
Vaucher
D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D017327:Clinical Trials, Phase IV as Topic / Q000379:methods; D016000:Cluster Analysis; D018562:Disease Transmission, Infectious; D004813:Epidemiology; D006801:Humans; D032521:Immunity, Herd; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D018401:Sample Size; D014612:Vaccines
D014612:Vaccines