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ERIC Number: EJ1253052
Record Type: Journal
Publication Date: 2020-Mar
Pages: 9
Abstractor: As Provided
ISBN: N/A
ISSN: ISSN-1759-2879
EISSN: N/A
From Registration to Publication: A Study on Dutch Academic Randomized Controlled Trials
Huiskens, Joost; Kool, Boudewijn R. J.; Bakker, Jean-Michel; Bruns, Emma R. J.; de Jonge, Stijn W.; Olthof, Pim B.; van Rosmalen, Belle V.; van Gulik, Thomas M.; Hooft, Lotty; Punt, Cornelis J. A.
Research Synthesis Methods, v11 n2 p218-226 Mar 2020
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 in 50 studies (39%). Conclusion: This study shows that approximately one out of four Dutch investigator-initiated RCTs remains unpublished 5 years after initiation. The observed low overall consistency with the initial study outline is a matter of concern and warrants improvements in trial design and assessment of trial feasibility.
Wiley-Blackwell. 350 Main Street, Malden, MA 02148. Tel: 800-835-6770; Tel: 781-388-8598; Fax: 781-388-8232; e-mail: cs-journals@wiley.com; Web site: http://www.wiley.com/WileyCDA
Publication Type: Journal Articles; Reports - Research
Education Level: N/A
Audience: N/A
Language: English
Sponsor: N/A
Authoring Institution: N/A
Identifiers - Location: Netherlands
Grant or Contract Numbers: N/A