Background: The successful completion of clinical trials ultimately depends on realistic recruitment predictions. Statistical methods for recruitment prediction implemented in a free-of-charge open-source software could be routinely used by researchers worldwide to design clinical trials. However, the availability of such software implementations is currently unclear.
Methods: Two independent reviewers conducted a systematic review following PRISMA guidelines. Eligible articles included English publications focused on statistical methods for recruitment prediction and monitoring that referred to software implementations. The list of articles retrieved from well-established data bases was enriched by backtracking of references provided by eligible articles. The current software availability and open-source status were tabulated.
Results: We found 21 eligible articles, 7 of which (33 %) provide freely accessible software. Ultimately, only one article provides a link to an easy-to-comprehend, well-documented, and currently directly applicable free-of-charge open-source software. The lack of availability is mainly caused by blocked access and outdated links.
Conclusions: While several software implementations exist for recruitment prediction, only a small fraction is freely accessible. These results highlight the need for future efforts to achieve free access to well-documented software implementations supporting researchers in routinely using statistical methods to arrive at realistic recruitment predictions in clinical trials.
Keywords: Clinical trial; Design stage; Free-of-charge open-source software; Planning; Recruitment prediction; Systematic review.
© 2024 The Authors.