Open Access Research

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

Stephanie M Zielinski1, Helena Viveiros2, Martin J Heetveld3, Marc F Swiontkowski4, Mohit Bhandari2, Peter Patka15, Esther MM Van Lieshout1* and on behalf of the FAITH trial investigators

Author Affiliations

1 Dept. of Surgery-Traumatology, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA Rotterdam, the Netherlands

2 Dept. of Clinical Epidemiology and Biostatistics, McMaster University, HSC 2C, 1200 Main Street West, Hamilton, ON, L8N 3Z5, Canada

3 Dept. of Surgery, Kennemer Gasthuis, P.O. Box 417, 2000 AK, Haarlem, the Netherlands

4 Dept. of Orthopaedic Surgery, University of Minnesota Medical School, 2512 South 7th Street, Suite R200, Minneapolis, MN, 55454, USA

5 Dept. of Emergency Medicine, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2010, 3000 CA Rotterdam, the Netherlands

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Trials 2012, 13:5  doi:10.1186/1745-6215-13-5

Published: 8 January 2012

Abstract

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.

Trial Registration

ClinicalTrials.gov: NCT00761813

Keywords:
randomized controlled trial; management; trial coordinator; trial performance; inclusion; follow-up