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From registration to publication: A study on Dutch academic randomized controlled trials
Author(s) -
Huiskens Joost,
Kool Boudewijn R.J.,
Bakker JeanMichel,
Bruns Emma R.J.,
Jonge Stijn W.,
Olthof Pim B.,
Rosmalen Belle V.,
Gulik Thomas M.,
Hooft Lotty,
Punt Cornelis J.A.
Publication year - 2020
Publication title -
research synthesis methods
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.376
H-Index - 35
eISSN - 1759-2887
pISSN - 1759-2879
DOI - 10.1002/jrsm.1379
Subject(s) - sample size determination , randomized controlled trial , clinical trial , medicine , consistency (knowledge bases) , clinical endpoint , protocol (science) , trial registration , accrual , research design , medline , family medicine , medical physics , alternative medicine , statistics , surgery , computer science , earnings , accounting , pathology , artificial intelligence , business , mathematics , political science , law
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 Conclusion This study shows that approximately one out of four Dutch investigator‐initiated RCTs remains unpublished 5 years after initiation.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.