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

Zielinski, Viveiros Helena, Heetveld, Swiontkowski, Bhandari Mohit, Patka Peter, Van, On

Description

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

Sujets

• Randomized controlled trial
• Management
• Inclusión

Informations

• Publié par: biomed
• Publié le: 01 janvier 2012
• Nombre de lectures: 199
• Langue: English

Extrait

Zielinskiet al.Trials2012,13:5 http://www.trialsjournal.com/content/13/1/5

TRIALS

R E S E A R C HOpen Access Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience 1 23 42 1,5 Stephanie M Zielinski , Helena Viveiros , Martin J Heetveld , Marc F Swiontkowski , Mohit Bhandari , Peter Patka 1* and Esther MM Van Lieshout, for on behalf of the FAITH trial investigators

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

Background Randomized controlled trials (RCTs) are generally per ceived as the reference standard for generating valid scientific evidence on the evaluation of medical treat ments and interventions [1]. Unfortunately, RCTs con tinue to be relatively scarce in the orthopedic trauma literature [2]. This may be attributed to the logistical challenges of the implementation of RCTs.

* Correspondence: [e-mail] 1 Dept. of SurgeryTraumatology, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA Rotterdam, the Netherlands Full list of author information is available at the end of the article

One of the most apparent challenges of RCTs is to recruit the required number of patients as timely and efficiently as possible [3]. Availability of fewer patients than expected usually leads to an extended trial period and increased costs. Multicenter collaborations offer the potential of recruiting more patients within a shorter time period, which can be advantageous if large patient numbers are required or if the targeted population has a low incidence. They also have the advantage of increased generalizability of the results [4,5]. However, the conduct of multicenter clinical trials requires a

© 2012 Zielinski et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.