Improving inclusion of under-served groups in clinical research: Guidance from INCLUDE project

The INCLUDE Project Guidance is a comprehensive framework developed by the UK National Institute for Health and Care Research (NIHR) to support researchers in improving the inclusion of under-served groups in clinical research. The guidance provides practical tools, checklists and recommendations to help research teams identify barriers to participation and implement strategies that promote equitable access throughout the planning and conduct of clinical studies. It addresses key aspects of trial delivery, including participant recruitment, communication, informed consent, study procedures, participant burden, retention and community engagement.

Although the guidance was developed within the UK research environment, the principles it promotes are broadly applicable across international clinical research. The challenges it addresses—including limited access to specialist centres, geographical barriers, communication needs, health literacy, cultural diversity and the inclusion of populations that are traditionally under-represented in research—are common across many healthcare systems and can be adapted to different regulatory and organisational contexts.

The guidance is particularly relevant to rare disease and paediatric clinical trials, where recruitment often depends on reaching small, geographically dispersed populations and ensuring that participation is accessible to patients and families with diverse needs. By encouraging researchers to consider inclusion early in trial planning and to reduce unnecessary barriers to participation, the guidance can help improve recruitment, participant retention and the representativeness of study populations. It complements methodological guidance on trial design by providing practical approaches to implementing participant-centred and inclusive clinical research, thereby supporting the successful delivery of rare disease clinical trials.