Objective To map open educational resources on how to justify, design, conduct, analyse, and share randomised clinical trials of healthcare interventions.

Design Landscape analysis.

Data sources Systematic 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 outcomes Categorisation 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).

Results We 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.

Conclusion We 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.

What is already known on this topic

Most conducted randomised clinical trials do not inform clinical practice and may be considered research waste.

A 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.

We decided to map open educational resources on randomised clinical trials to create a one-stop collection and to identify gaps in the landscape.

What this study adds

We identified an array of open educational resources, covering large parts of the clinical trial life cycle.

There are important gaps in the landscape, most importantly regarding the justification of new randomised clinical trials.

KB and CG are developing a publicly available, freely accessible blended learning curriculum on randomised clinical trials. FS is a co-applicant on the CONSCIOUS II program and leads the Trial Forge Centre in University College Cork. ST leads Trial Forge. SLK reports no conflicts. None of the authors have financial conflicts related to the topic.

https://doi.org/10.1101/2024.02.16.24302873

Copenhagen Trial Unit, Centre for Clinical Intervention Research, Denmark paid the salaries of KB, SLK, and CG.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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