TY - JOUR
T1 - Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience
AU - Zielinski, Stephanie M.
AU - Viveiros, Helena
AU - Heetveld, Martin J.
AU - Swiontkowski, Marc F.
AU - Bhandari, Mohit
AU - Patka, Peter
AU - van Lieshout, Esther M. M.
AU - AUTHOR GROUP
AU - Devereaux, Philip J.
AU - Guyatt, Gordon
AU - Jeray, Kyle
AU - Liew, Susan
AU - Richardson, Martin J.
AU - Schemitsch, Emil H.
AU - Swiontkowski, Marc
AU - Tornetta, Paul
AU - Walter, Stephen
AU - Sprague, Sheila
AU - Simunovic, Helena Viveiros Nicole
AU - Heels-Ansdell, Diane
AU - Buckingham, Lisa
AU - Duraikannan, Aravin
AU - Agel, Julie
AU - Goslings, J. Carel
AU - Haverlag, Robert
AU - Ponsen, Kees Jan
AU - Eversdijk, Martin G.
AU - Peters, Rolf
AU - den Hartog, Dennis
AU - van Waes, Oscar J. F.
AU - Oprel, Pim
AU - de Rijcke, Piet A. R.
AU - Koppert, C. L.
AU - Buijk, Steven E.
AU - Groenendijk, Richard P. R.
AU - Dawson, I.
AU - Tetteroo, G. W. M.
AU - Bruijninckx, Milko M. M.
AU - Doornebosch, Pascal G.
AU - deGraaf, E. J. R.
AU - Visser, Gijs A.
AU - Stockmann, Heyn
AU - Silvis, Rob
AU - Snellen, J. P.
AU - Rijbroek, A.
AU - Scheepers, Joris J. G.
AU - Vermeulen, Erik G. J.
AU - Siroen, M. P. C.
AU - Festen, Sebastiaan
AU - Schep, Niels W. L.
AU - Campo, Martin
PY - 2012
Y1 - 2012
N2 - Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217). In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. ClinicalTrials.gov: NCT00761813
AB - Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217). In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. ClinicalTrials.gov: NCT00761813
U2 - https://doi.org/10.1186/1745-6215-13-5
DO - https://doi.org/10.1186/1745-6215-13-5
M3 - Article
C2 - 22225733
SN - 1745-6215
VL - 13
SP - 5
JO - Trials
JF - Trials
ER -