Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience.
BACKGROUND
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov: NCT00761813.
Dept, of Surgery-Traumatology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA Rotterdam, the Netherlands.
Stephanie M
SM
Zielinski
Helena
H
Viveiros
Martin J
MJ
Heetveld
Marc F
MF
Swiontkowski
Mohit
M
Bhandari
Peter
P
Patka
Esther M M
EM
Van Lieshout
D000288:Administrative Personnel / Q000191:economics / Q000458:organization & administration*; D002170:Canada; D003299:Cooperative Behavior; D017598:Efficiency, Organizational; D028744:Ethics Committees, Research; D005592:Fracture Fixation / Q000191:economics / Q000379:methods*; D006620:Hip Fractures / Q000191:economics / Q000601:surgery*; D006801:Humans; D009426:Netherlands; D018579:Patient Selection; D012107:Research Design; D012108:Research Personnel / Q000191:economics / Q000458:organization & administration*; D012109:Research Support as Topic; D018401:Sample Size; D013997:Time Factors; D014481:United States