Development and evaluation of a complex intervention designed to improve the accessibility of clinical trials for disabled and neurodivergent people: protocol for the PRACTICALs pilot study

Evidence suggests that disabled and neurodivergent people are frequently excluded from clinical trials by strict eligibility criteria and poorly designed or inflexible trial protocols and processes. This has a significant impact on health and wellbeing, compromises the generalisability of findings on the safety and effectiveness of new interventions, and prevents disabled and neurodivergent people from having fair and equitable access to trial participation opportunities. Guidance on how to design trials that are inclusive of disabled and neurodivergent people is currently scarce, but protocol design and ethical approval processes have been identified as playing a key role. Consequently, this protocol reports on the development and evaluation of the Promoting Accessibility in Clinical Trials (PRACTICALs) intervention, designed for protocol contributors and research ethics committee (REC) members to improve the accessibility of clinical trials for disabled and neurodivergent people. The intervention development, undertaken in partnership with the charity Disability Rights UK and the study’s stakeholder group of disabled people and target users of the intervention, is underpinned by the Behaviour Change Wheel and guided by the Person-Based Approach. The intervention, which comprises a guidance handbook and e-learning module, incorporates 17 behaviour change techniques. It will be tested in a longitudinal, single-arm, mixed-methods pilot study to assess its acceptability, relevance and potential impact, using the Kirkpatrick Model as an evaluative tool. Participants will be 60 clinical trials researchers, REC members and Patient and Public Involvement contributors that have written, contributed to, or reviewed a clinical trial protocol or intend to do so in the three months following their enrolment in the study. We hypothesise that the PRACTICALs intervention will have an impact on clinical trial design and lead to greater representation of disabled and neurodivergent people in clinical trials, therefore promoting equity in trial participation opportunities and enhancing the generalisability of trial findings.