A systems framework for improving clinical trial recruitment: A literature-informed approach.

Introduction: Recruitment and retention of populations with limited prior participation in clinical trials remains a challenge. Thus, an increased understanding of the complex factors that impede or facilitate recruitment and retention is needed. Adapting the Systems Engineering Initiative for Patient Safety (SEIPS), we developed the Systems Engineering Initiative for Participant-Centric Research (SEIPR) framework that researchers can use to develop, implement, and evaluate interventions to increase trial participation. Methods: We performed a non-systematic literature review using the digital databases PubMed and Google Scholar to determine factors facilitating and impeding involvement of populations with limited prior participation in clinical trials. From this literature, we developed the SEIPR framework by applying it to the context of recruitment and retention. Results: We organized key obstacles and evidence-based solutions into five framework components: Person, Tasks and Tools, Technology, Physical Environment, and Organizational Conditions. Common obstacles included lack of awareness of active trials by participants and healthcare providers, patient's distance from trial centers, lack of access to traditional advertising technology, and mistrust towards investigators, among others. Solutions included promotional strategies appropriate to the regional or social context, decentralizing trials, providing communication technology to participants, partnering with trusted members from the participant's community and primary care team, using local connections and community centers, financial incentives, and transportation solutions. Discussion: The SEIPR framework presents a promising tool for investigators interested in increasing participant breadth in clinical trials. Future research is needed to explore real-world applications and assess its effectiveness in recruiting and retaining broad populations.