BACKGROUND
Randomized clinical trials (RCTs) are foundational to the advancement of evidence-based medicine and recruiting a sufficient number of participants is one of the crucial steps to their successful conduct. Yet, poor recruitment remains the most frequent reason for premature discontinuation or costly extension of clinical trials.
OBJECTIVE
Describe the design and implementation of an application to support the recruitment process in clinical trials by generating automatic recruitment recommendations.
METHODS
Based on previously published work on architecture and user requirements, we designed and implemented a patient recruitment support system.
RESULTS
The system is based on the OMOP CDM as a repository of patient data that is continuously queried for possible trial candidates based on given clinical trial eligibility criteria. A web-based screening list can be used to display the candidates and email notifications about possible new trial participants can be automatically sent. All interactions between services are using HL7 FHIR as the communication standard. The system can be installed using standard container technology and supports highly-available deployments on Kubernetes clusters.
CONCLUSIONS
We contribute a novel, open-source implementation to support the patient recruitment process in clinical trials that can be deployed using state-of-the art technologies.