Making it easier for trial teams to design inclusive trials

试验参与者需要代表那些有意从试验结果中受益的社会群体。每个审判中最需要代表的群体各不相同。一种试验中服务不足的群体可能与另一种试验截然不同。一些研究没有纳入服务不足人群的原因可能很复杂，但如果从试验一开始就考虑解决纳入障碍的办法，则更容易确定。交叉性进一步认识到可能存在多种因素（例如种族和性别），这些因素结合在一起并导致不利或歧视。这一理论描述了个人如何同时受到一系列不同的连锁权力系统的影响，这些系统决定了他们自己独特的歧视经历。作为研究人员，我们必须考虑所有可能使人们被排斥在试验之外的因素——性别、种族、阶级、性取向、体能、移民身份等等。最近开发了一些工具，称为INCLUDE框架（参见https://www.trialforge.org/trial-forge-centre/diversity/），以帮助试验团队考虑他们的设计决策如何使某些组的参与变得容易或困难。每个框架都侧重于单个服务不足的群体。目前有侧重于种族、同意能力受损的成年人和社会经济劣势的方案，还有更多方案正在开发中。然而，有一种风险是，试用者可能会被可用框架的数量所淹没，如果没有仔细考虑重叠，则可能会错过组之间存在的任何交叉性。这个项目的目标是为试用团队提供一个简化的流程，以有效地在框架中导航。要做到这一点，我们首先需要确定不同服务不足群体之间存在交集的地方，以及这对研究人员在设计试验时需要考虑这些群体意味着什么。此外，该项目将考虑什么样的提示可以使研究人员有效地深入研究这些交叉人群在参与时可能遇到的障碍和挑战。最后，该项目将调查研究人员可以提供什么样的解决方案，以确保这些关键的框架问题不仅被提出，而且被采取行动，以确保他们的试验在实践中真正具有包容性。

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.