Mapping open educational resources on how to justify, design, conduct, analyse, and share randomised clinical trials: a landscape analysis
Boesen, K.; Shiely, F.; Treweek, S.; Klingenberg, S.; Gluud, C.
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ObjectiveTo map open educational resources on how to justify, design, conduct, analyse, and share randomised clinical trials of healthcare interventions. DesignLandscape analysis. Data sourcesSystematic searches of multiple databases of biomedical literature using ASReview, a machine learning assisted systematic review tool, to screen the most relevant records. Manual searches of general websites, regulatory and clinical trial unit websites, and online learning portals. Main outcomesCategorisation and reporting of included resources according to type (e-learning, dedicated trial platform, scattered website material, e-books, and videos), format (guidance, templates, research publications, and tools), and trial stage content (justification, design, conduct, analysis, and sharing). ResultsWe included 63 open educational resources categorised as dedicated trial portals (n=22), e-learning courses (n=20), scattered website material (n=10), videos and webinars (n=9), and e-books (n=2). Various formats were used and the content distribution according to trial stage was skewed towards design (n=47) and conduct (n=51), with fewer resources on justification (n=12), analysis (n=27), and sharing (n=23). Few resources provided clear and instructive navigation roadmaps for users or catalogued their content according to the clinical trial lifecycle. ConclusionWe identified a range of open educational resources on how to justify, design, conduct, analyse, and share randomised clinical trials. Most content focused on trial design and conduct, whereas some aspects of trial justification were entirely absent. Most resources lacked a clear roadmap to catalogue the content. The available resources provide valuable and extensive information, but users must be wary of important gaps in the existing landscape of educational material on randomised clinical trials. New open educational resources should provide clear roadmaps and address the underprioritised areas of the trial life cycle. Review registrationhttps://doi.org/10.1101/2024.02.16.24302873 (preprinted 17 February 2024). Summary boxesO_ST_ABSWhat is already known on this topicC_ST_ABSO_LIMost conducted randomised clinical trials do not inform clinical practice and may be considered research waste. C_LIO_LIA lack of access to learning materials on how to justify, design, conduct, analyse, and share randomised clinical trials may be one possible factor to research waste. C_LIO_LIWe decided to map open educational resources on randomised clinical trials to create a one-stop collection and to identify gaps in the landscape. C_LI What this study addsO_LIWe identified an array of open educational resources, covering large parts of the clinical trial life cycle. C_LIO_LIThere are important gaps in the landscape, most importantly regarding the justification of new randomised clinical trials. C_LI
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