Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process

Area of Science:

• Clinical research methodology
• Health equity
• Participant engagement

Background:

• Clinical research participant demographics often do not mirror the populations needing healthcare interventions.
• Enhancing the inclusion of under-served groups in clinical research is crucial for the broad applicability of findings.
• A multicomponent project was undertaken to improve the representation of under-served populations in clinical trials.

Purpose of the Study:

• To identify and define under-served groups in clinical research.
• To understand barriers to the inclusion of under-served groups in clinical trials.
• To develop a strategic roadmap for enhancing the representation of under-served groups in clinical research.

Main Methods:

• A scoping review of literature to identify under-served groups and inclusion barriers.
• Surveys of stakeholders and participant representatives to refine findings and identify best practices.
• Workshops with key stakeholders to reach consensus on definitions, barriers, and a future strategic roadmap.

Main Results:

• 'Under-served groups' was adopted as the preferred terminology.
• Challenges in defining under-served groups were noted, with examples like those facing language barriers or mental illness identified.
• Key barriers included communication gaps, trial design/delivery issues, differing stakeholder agendas, and lack of trust.
• Four goals were established: building relationships, developing training, improving infrastructure, and removing systemic barriers.

Conclusions:

• Future work will focus on generating tailored resources for different under-served groups.
• The aim is to enhance the representativeness of trial populations through customized support.
• The INCLUDE group will implement these findings over the next 12 months.