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From registration to publication: A study on Dutch academic randomized controlled trials

From registration to publication: A study on Dutch academic randomized controlled trials

Authors :
Huiskens, J. (Joost)
Kool, B.R.J. (Boudewijn R.J.)
Bakker, J.-M. (Jean-Michel)
Bruns, E.R.J. (Emma R.J.)
de Jonge, S.W. (Stijn W.)
Olthof, P.B. (Pim B.)
van Rosmalen, B.V. (Belle V.)
Gulik, T.M. (Thomas) van
Hooft, L. (Lotty)
Punt, C.J.A. (Cornelis)
Huiskens, J. (Joost)
Kool, B.R.J. (Boudewijn R.J.)
Bakker, J.-M. (Jean-Michel)
Bruns, E.R.J. (Emma R.J.)
de Jonge, S.W. (Stijn W.)
Olthof, P.B. (Pim B.)
van Rosmalen, B.V. (Belle V.)
Gulik, T.M. (Thomas) van
Hooft, L. (Lotty)
Punt, C.J.A. (Cornelis)
Publication Year :
2019

Abstract

Introduction: Registration of clinical trials has been initiated in order to assess adherence of the reported results to the original trial protocol. This study aimed to investigate the publication rates, timely dissemination of results, and the prevalence of consistency in hypothesis, sample size, and primary endpoint of Dutch investigator-initiated randomized controlled clinical trials (RCTs). Methods: All Dutch investigator-initiated RCTs with a completion date between December 31, 2010, and January 1, 2012, and registered in the Trial Register of The Netherlands database were included. PubMed was searched for the publication of these RCT results until September 2016, and the time to the publication date was calculated. Consistency in hypothesis, sample size, and primary endpoint compared with the registry data were assessed. Results: The search resulted in a total of 168 Dutch investigator-initiated RCTs. In September 2016, the results of 129 (77%) trials had been published, of which 50 (39%) within 2 years after completion of accrual. Consistency in hypothesis with the original protocol was observed in 108 (84%) RCTs; in 71 trials (55%), the planned sample size was reached; and 103 trials (80%) presented the original primary endpoint. Consistency in all three parameters was observed

Details

Database :
OAIster
Notes :
application/pdf, Research Synthesis Methods, English
Publication Type :
Electronic Resource
Accession number :
edsoai.on1143371241
Document Type :
Electronic Resource
Full Text :
https://doi.org/10.1002.jrsm.1379