Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience.
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.
Trial Registration: ClinicalTrials.gov: NCT00761813
Zielinski, Stephanie M.
68118f25-3948-4eaf-8924-cd981d324112
Viveiros, Helena
6a7cf0dd-7056-45a4-90f9-7a26bcbccb8b
Heetveld, Martin J.
22abc67c-51ac-466c-bd7f-95320ce1fd16
Swiontkowski, Marc F.
d26a0321-caef-4765-8367-1d530894538d
Bhandari, Mohit
85e90feb-268b-4a18-81c0-e23042a3de34
Patka, Peter
faca2254-2f11-4058-8c9e-fb93d3a4463a
Van Lieshout, Esther M.M.
9c1272f0-bfbf-4efe-9b34-aea9394a2dda
investigators, FAITH trial
cf362f8d-2934-4457-9370-05cc85f255e0
Mcbeth, John
98012716-66ba-480b-9e43-ac53b51dce61
on behalf of the FAITH trial investigators
8 January 2012
Zielinski, Stephanie M.
68118f25-3948-4eaf-8924-cd981d324112
Viveiros, Helena
6a7cf0dd-7056-45a4-90f9-7a26bcbccb8b
Heetveld, Martin J.
22abc67c-51ac-466c-bd7f-95320ce1fd16
Swiontkowski, Marc F.
d26a0321-caef-4765-8367-1d530894538d
Bhandari, Mohit
85e90feb-268b-4a18-81c0-e23042a3de34
Patka, Peter
faca2254-2f11-4058-8c9e-fb93d3a4463a
Van Lieshout, Esther M.M.
9c1272f0-bfbf-4efe-9b34-aea9394a2dda
investigators, FAITH trial
cf362f8d-2934-4457-9370-05cc85f255e0
Mcbeth, John
98012716-66ba-480b-9e43-ac53b51dce61
Zielinski, Stephanie M., Viveiros, Helena, Heetveld, Martin J., Swiontkowski, Marc F., Bhandari, Mohit, Patka, Peter, Van Lieshout, Esther M.M. and investigators, FAITH trial
,
on behalf of the FAITH trial investigators
(2012)
Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience.
Trials, 13 (5), [5].
(doi:10.1186/1745-6215-13-5).
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
Text
1745-6215-13-5
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Accepted/In Press date: 8 January 2012
Published date: 8 January 2012
Identifiers
Local EPrints ID: 491786
URI: http://eprints.soton.ac.uk/id/eprint/491786
ISSN: 1745-6215
PURE UUID: fbb1871c-d901-44da-af7f-db62e13de143
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Date deposited: 04 Jul 2024 16:33
Last modified: 12 Jul 2024 02:17
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Contributors
Author:
Stephanie M. Zielinski
Author:
Helena Viveiros
Author:
Martin J. Heetveld
Author:
Marc F. Swiontkowski
Author:
Mohit Bhandari
Author:
Peter Patka
Author:
Esther M.M. Van Lieshout
Author:
FAITH trial investigators
Author:
John Mcbeth
Corporate Author: on behalf of the FAITH trial investigators
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