Promoting Accessibility in Clinical Trials (PRACTICALs): Pilot testing of an e-learning resource

Between 16.5% of men and 18.7% of women in England are disabled, and yet disabled people face worse access to healthcare in the UK, with long waiting lists and distance or transportation problems identified as the greatest barriers. Clinical research in healthcare settings risks replicating these systemic barriers in addition to the burden of research activity; disabled people may be excluded from some trials by strict eligibility criteria, but they are also inadvertently excluded by poorly designed or inflexible trial protocols and processes, such as requirements for in-person study visits and written informed consent. Designing trials that work for disabled and neurodivergent people is not only critical to the success of research into long-term conditions and multi-morbidities, but also vital to the generalisability of findings on the safety and efficacy of new interventions, and in ensuring fair and equal access to participation in trials. However, guidance on how to achieve this is currently scarce. Protocol design and consent and ethics processes play a key role in ensuring equitable trial design. This study therefore aims to pilot test an e-learning resource for people who write or contribute to clinical trial protocols and ethics committee members who review clinical trial protocols to: 1) Increase awareness that some trial participants may be disabled and/or neurodivergent (even if the study population isn’t usually considered disabled by virtue of the condition being studied), and/or that they may have access needs; 2) Increase awareness of what they can do to make clinical trials more accessible for disabled and neurodivergent people; 3) Increase their confidence to raise the issue of disability access within their research team; and 4) Increase their ability to make ethical arguments to support the adjustments they are implementing.