Redesigning trials to be inclusive of people with a learning disability-a practical example.

backgroundPeople with a learning disability are frequently excluded from clinical trials, with around two thirds of trials either directly or indirectly excluding this group. This contributes to the shocking health inequalities they experience, with people with a learning disability having higher rates of long-term health conditions and dying on average 20 years younger than the general population. Improving inclusion of under-served groups in trials is a priority area for research funders and regulators. A UK-wide collaboration, 'No Research About Us, Without Us', was formed to explore and address the barriers to engaging and involving people with a learning disability in research. The project consisted of a number of intersecting work streams. This paper reports the findings from Working Group 3 which aimed to produce practical examples about how a trial could be redesigned to ensure it is more inclusive of people with a learning disability.

methodsThe redesign process consisted of three steps: (1) identifying an appropriate trial using predefined criteria, (2) selecting a tool to systematically review the trial, and (3) identifying barriers to inclusion of people with a learning disability and proposing alternative design approaches that could have widened access to the trial.

resultsFollowing review of a funder's portfolio, we selected a platform trial (PANORAMIC) which had sought to include people with a learning disability as a high-risk group for COVID-19 and yet had only made up 0.01% of those recruited. Using the INCLUDE Impaired Capacity to Consent Framework, our co-produced analysis identified practical strategies that could have ensured greater inclusion of people with a learning disability. This included involving people with a learning disability at the earliest design stage, revisiting eligibility criteria, making reasonable adjustments (e.g. high-quality easy read versions of all documents), and simplifying overly complex study processes.

conclusionTo achieve better health equity and improve the quality of clinical trials, researchers must pay greater attention to accessible study design and ensure appropriate accommodations are in place to enable inclusion of people with a learning disability. We outline some practical strategies that can inform the design and conduct of future trials to improve inclusion.