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

Trials

On behalf of the INCLUDE writing group¹  Alistair S. Hall²  Gail A. Mountain³  Sarah R. Prowse⁴  Eleanor Anderson⁵  Gary Nestor⁵  Kim Down⁵  Miles D. Witham⁵  Lynn Rochester⁵  Joanna Knee⁶  Laurie Oliva⁶  Paul M. Dark⁷  Amanda Tortice⁸  Rebecca H. Maier⁹  James Wason^1,10  Camille Carroll^1,11 

[1] ;Cardiology Department, Leeds General Infirmary;Centre for Applied Dementia Studies, University of Bradford;Institute of Applied Health Sciences, University of Aberdeen;NIHR Clinical Research Network Cluster E, Campus for Ageing and Vitality, Newcastle University;NIHR Clinical Research Network Coordinating Centre;NIHR Manchester Biomedical Research Centre, University of Manchester and Northern Care Alliance NHS Group;NIHR Yorkshire and Humber Local Clinical Research Network;Newcastle Clinical Trials Unit, 1-4 Claremont Terrace, Newcastle University;Population Health Sciences Institute, Newcastle University;University of Plymouth, Faculty of Health;

关键词: Trials;    Roadmap;    Under-served;    Recruitment;    Stakeholder;   

DOI  :  10.1186/s13063-020-04613-7

来源: DOAJ

【 摘 要 】

Abstract Background Participants in clinical research studies often do not reflect the populations for which healthcare interventions are needed or will be used. Enhancing representation of under-served groups in clinical research is important to ensure that research findings are widely applicable. We describe a multicomponent workstream project to improve representation of under-served groups in clinical trials. Methods The project comprised three main strands: (1) a targeted scoping review of literature to identify previous work characterising under-served groups and barriers to inclusion, (2) surveys of professional stakeholders and participant representative groups involved in research delivery to refine these initial findings and identify examples of innovation and good practice and (3) a series of workshops bringing together key stakeholders from funding, design, delivery and participant groups to reach consensus on definitions, barriers and a strategic roadmap for future work. The work was commissioned by the UK National Institute for Health Research Clinical Research Network. Output from these strands was integrated by a steering committee to generate a series of goals, workstream plans and a strategic roadmap for future development work in this area. Results ‘Under-served groups’ was identified and agreed by the stakeholder group as the preferred term. Three-quarters of stakeholders felt that a clear definition of under-served groups did not currently exist; definition was challenging and context-specific, but exemplar groups (e.g. those with language barriers or mental illness) were identified as under-served. Barriers to successful inclusion of under-served groups could be clustered into communication between research teams and participant groups; how trials are designed and delivered, differing agendas of research teams and participant groups; and lack of trust in the research process. Four key goals for future work were identified: building long-term relationships with under-served groups, developing training resources to improve design and delivery of trials for under-served groups, developing infrastructure and systems to support this work and working with funders, regulators and other stakeholders to remove barriers to inclusion. Conclusions The work of the INCLUDE group over the next 12 months will build on these findings by generating resources customised for different under-served groups to improve the representativeness of trial populations.

【 授权许可】

Unknown