title: The permuted locus trial--Well suited for emerging pathogens?
abstract: The recent Ebola virus epidemic was waning by the time stakeholders were ready to field vaccines for testing but an evidence-based response to a novel pathogen will surely be required again. Here, we present a design for such a randomized controlled trial. The permuted locus trial was originally intended for studying the influence of water wells on trachoma. While outcomes can be measured in individuals, neither individuals nor groups are themselves randomized to arms, just potential well-sites, or in the case of an epidemic, index cases. The permuted locus trial may be used when classic individual and cluster-randomized trial design and analyses may not be optimal.
authors.affiliation: F.I. Proctor Foundation, University of California San Francisco, San Francisco, CA, USA; Department of Ophthalmology, University of California San Francisco, San Francisco, CA, USA; Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, CA, USA.
authors.forename: Travis C
authors.initials: TC
authors.lastname: Porco
authors.affiliation: F.I. Proctor Foundation, University of California San Francisco, San Francisco, CA, USA; Department of Ophthalmology, University of California San Francisco, San Francisco, CA, USA.
authors.forename: Jeremy D
authors.initials: JD
authors.lastname: Keenan
authors.affiliation: Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, CA, USA.
authors.forename: Wayne T A
authors.initials: WT
authors.lastname: Enanoria
authors.affiliation: F.I. Proctor Foundation, University of California San Francisco, San Francisco, CA, USA; Department of Ophthalmology, University of California San Francisco, San Francisco, CA, USA; Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, CA, USA. Electronic address: tom.lietman@ucsf.edu.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Lietman
mesh_terms: D046129:Ebola Vaccines / Q000627:therapeutic use*; D019142:Hemorrhagic Fever, Ebola / Q000517:prevention & control*; D006801:Humans; D012107:Research Design; D014141:Trachoma / Q000517:prevention & control; D060986:Water Wells
chemical_list: D046129:Ebola Vaccines
keywords: Cluster randomized controlled trial; Ebola; Permuted locus trial; Trachoma; Water wells