Abstract
ObjectivesTimely and comprehensive reporting of clinical trial results builds the backbone of evidence-based medicine and responsible research. The proportion of timely disseminated trial results can inform alternative national and international benchmarking of university medical centers (UMCs). Study Design and SettingFor all German UMCs, we tracked all registered trials completed between 2009 and 2013. The results and an interactive website benchmark German UMCs regarding their performance in result dissemination. ResultsWe identified and tracked 2,132 clinical trials. For 1,509 trials, one of the German UMCs took the academic lead. Of these 1,509 “lead trials,” 39% published their results (mostly via journal publications) in a timely manner (<24 months after completion). More than 6 years after study completion, 26% of all eligible lead trials still had not disseminated results. ConclusionDespite substantial attention from many stakeholders to the topic, there is still a strong delay or even absence of result dissemination for many trials. German UMCs have several opportunities to improve this situation. Further research should evaluate whether and how a transparent benchmarking of UMC performance in result dissemination helps to increase value and reduce waste in medical research.
Highlights
The results of clinical trials build the backbone of evidence-based medicine
Demographic data We identified 2,132 clinical trials via clinicaltrial.gov (n=1,905) and DRKS (n=227) that i) recruited trial participants from at least one German university medical centres (UMCs) and ii) had their primary completion date (PCD, last visit of last patient for a primary outcome measure) between 2009 and 2013
We demonstrate that only 39% of all registered clinical trials conducted at one of the 36 German UMCs published their results in a timely manner within 24 months after the trial’s completion date (CD)
Summary
The results of clinical trials build the backbone of evidence-based medicine. They inform clinical decision making [1] and health technology assessment [2, 3]. They inform decision making within ongoing trials and decision making related to the design, review, and funding of new trials [4]. Since 2008, the Declaration of Helsinki includes the requirements that every study involving human subjects should be prospectively registered and that all results should be made publicly available – irrespective of the results’ direction [12]. The joint statement by the World Health Organization in 2015 defined “timely publication” as “24 months for publication in a peer-reviewed journal (preferably open-access) and 12 months for publication of the key results in the registry’s result section” [8]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
