title: A randomised trial of the effects of an additional communication strategy on recruitment into a large-scale, multi-centre trial.
abstract: Timely participant recruitment remains a significant challenge for most clinical trials. We evaluated the effects on participant recruitment of communication between the central trial coordinators and the clinical sites in the setting of a large international multi-centre clinical trial. The effects of communication were determined in a single-blind randomised controlled trial involving 167 clinical sites in 19 countries. Clinical sites were randomised to either additional or usual communication strategies - the additional communication group received a communication package based on additional, individually-tailored feedback about recruitment, in addition to the usual correspondence from the central trial coordinators that was provided to the control group. The two study outcomes were the median time to half randomisation target and the median total number of participants randomised per clinical site. Eighty-five clinical centres were randomised to receive additional communication and 82 to receive usual communication. At the conclusion of recruitment, there was no significant difference in the median number of participants randomised per centre between the additional and usual groups (37.5 vs. 37.0, p=0.68). The median time to half randomisation target was lower in the additional communication group compared to the usual group, however this difference did not achieve conventional levels of statistical significance (4.4 months vs. 5.8 months, p=0.08). The findings suggest that the additional communication strategy may be of some incremental benefit in helping sites achieve recruitment targets sooner.
authors.affiliation: The George Institute for International Health, University of Sydney, PO Box M201, Missenden Road, Sydney, NSW 2050, Australia. hmonaghan@george.org.au
authors.forename: Helen
authors.initials: H
authors.lastname: Monaghan
authors.forename: Anna
authors.initials: A
authors.lastname: Richens
authors.forename: Sam
authors.initials: S
authors.lastname: Colman
authors.forename: Rochelle
authors.initials: R
authors.lastname: Currie
authors.forename: Seham
authors.initials: S
authors.lastname: Girgis
authors.forename: Kathy
authors.initials: K
authors.lastname: Jayne
authors.forename: Bruce
authors.initials: B
authors.lastname: Neal
authors.forename: Anushka
authors.initials: A
authors.lastname: Patel
mesh_terms: D003142:Communication; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods*; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*