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

Area of Science:

• Clinical research methodology
• Health services research
• Patient engagement strategies

Background:

• Recruitment and retention of diverse populations in clinical trials present significant challenges.
• Understanding factors that hinder or help participation is crucial for trial success.
• Existing frameworks need adaptation to address participant-centric research needs.

Purpose of the Study:

• To develop a novel framework to enhance clinical trial recruitment and retention.
• To provide researchers with a tool for designing and evaluating interventions for broader trial participation.
• To adapt the Systems Engineering Initiative for Patient Safety (SEIPS) for participant-centric research.

Main Methods:

• A non-systematic literature review of PubMed and Google Scholar was conducted.
• Identified factors facilitating and impeding participation of underrepresented groups.
• Developed the Systems Engineering Initiative for Participant-Centric Research (SEIPR) framework based on literature findings.

Main Results:

• Key obstacles were categorized into five components: Person, Tasks and Tools, Technology, Physical Environment, and Organizational Conditions.
• Identified common barriers such as lack of awareness, distance, limited technology access, and mistrust.
• Highlighted solutions including context-specific promotion, trial decentralization, communication technology, community partnerships, and financial/transportation support.

Conclusions:

• The SEIPR framework offers a structured approach for increasing participant diversity in clinical trials.
• The framework can guide the development, implementation, and evaluation of targeted interventions.
• Further research is warranted to assess the real-world effectiveness of the SEIPR framework in diverse populations.