Time to STEP UP: methods and findings from the development of guidance to help researchers design inclusive clinical trials

作者：Katie Biggs, Katie Hullock, Caroline Dix, J. Athene Lane, Heidi Green, Shaun Treweek, Frances Shiely, Victoria Shepherd, Andrew Willis, Talia Isaacs, Cindy Cooper · 发表于：BMC Medical Research Methodology · 年份：2024 · DOI：10.1186/s12874-024-02342-y · 被引用次数：15 · 研究领域：Ethics in Clinical Research、Adolescent and Pediatric Healthcare、Health Systems, Economic Evaluations, Quality of Life

BACKGROUND: It is important to design clinical trials to include all those who may benefit from the intervention being tested. Several frameworks have been developed to help researchers think about the barriers to inclusion of particular under-served groups when designing a trial, but there is a lack of practical guidance on how to implement these frameworks. This paper describes the ACCESS project, the findings from each phase of the project and the guidance we developed (STEP UP) on how to design more inclusive trials. METHODS: Development of the STEP UP guidance had five phases: (1) Scoping literature review, (2) 'roundtable' discussion meetings, (3) redesign of trials, (4) interviews and (5) guidance document development, with input from public contributors and the ACCESS team. RESULTS: Over 40 experts contributed to the ACCESS project-patients and the public, clinicians, NHS research staff, trialists and other academics. The scoping review identified several strategies being used to improve inclusion, mostly around recruitment settings, but there was little evaluation of these strategies. The 'roundtable' discussions identified additional strategies being used across the UK and Ireland to improve inclusion, which were grouped into: Communication, Community engagement, Recruitment sites, Patient information, Flexibility, Recruitment settings, Consent process, Monitoring, Training for researchers and Incentives. These strategies were used to redesign three existing trials ...