Making it easier for trial teams to design inclusive trials

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Trial participants need to represent those in society who are intended to benefit from the outcomes of the trial. The groups needing representation most will vary from trial to trial. An under-served group for one type of trial may be very different to that of another. Reasons for why under-served groups are not included in some research can be complex, but solutions to resolve inclusion barriers are easier to determine if considered from the outset of a trial. Intersectionality goes a step further in recognising that there may be multiple factors (for example ethnicity and gender) that combine and lead to disadvantage or discrimination. This theory describes how individuals may be affected by a range of different interlocking systems of power at the same time, which dictate their own unique experiences of discrimination. As researchers, we must consider everything and anything that can marginalise people from participating in a trial - gender, ethnicity, class, sexual orientation, physical ability, migrant status, etc. A few tools have recently been developed called the INCLUDE Frameworks (see https://www.trialforge.org/trial-forge-centre/diversity/) to help trial teams to think about how their design decisions might make it easy or difficult for some groups to take part. Each Framework focuses on an individual under-served group. At present there are ones focused on ethnicity, adults with impaired capacity to consent and socioeconomic disadvantage, and more are in development. However, there is a risk that trialists may become overwhelmed with the number of Frameworks available, and any intersectionality that exists between the groups may be missed if overlap is not thoughtfully considered.The goal of this project is to provide trial teams with a streamlined process to efficiently navigate their way through the Frameworks. To do this, we will firstly need to determine where intersectionality between different under-served groups exist and what this means for researchers who will need to consider these groups when designing their trials. Additionally, the project will consider what kinds of prompts can enable researchers to effectively delve into the barriers and challenges that these intersectional populations may have with participation. Finally, the project will investigate what kinds of solutions researchers could be given to make sure that these critical Framework questions are not only asked but actioned, to ensure their trials are truly inclusive in practice.