Background: Clinical trials often struggle to recruit enough participants, with only 10% of eligible patients enrolling. This is concerning for conditions like stroke, where timely decision-making is crucial. Frontline clinicians typically screen patients manually, but this approach can be overwhelming and lead to many eligible patients being overlooked.
Methods: To address the problem of efficient and inclusive screening for trials, we developed a matching algorithm using imaging and clinical variables gathered as part of the AcT trial (NCT03889249) to automatically screen patients by matching these variables with the trials' inclusion and exclusion criteria using rule-based logic. We then used the algorithm to identify patients who could have been enrolled in six trials: EASI-TOC (NCT04261478), CATIS-ICAD (NCT04142125), CONVINCE (NCT02898610), TEMPO-2 (NCT02398656), ESCAPE-MEVO (NCT05151172), and ENDOLOW (NCT04167527). To evaluate our algorithm, we compared our findings to the number of enrollments achieved without using a matching algorithm. The algorithm's performance was validated by comparing results with ground truth from a manual review of two clinicians. The algorithm's ability to reduce screening time was assessed by comparing it with the average time used by study clinicians.
Results: The algorithm identified more potentially eligible study candidates than the number of participants enrolled. It also showed over 90% sensitivity and specificity for all trials, and reducing screening time by over 100-fold.
Conclusions: Automated matching algorithms can help clinicians quickly identify eligible patients and reduce resources needed for enrolment. Additionally, the algorithm can be modified for use in other trials and diseases.
Keywords: clinical trials; ischemic stroke; matching algorithm; stroke; trial enrollment.