Making it easier for trial teams to design inclusive trials

试验参与者需要代表社会上那些打算从试验结果中受益的人。最需要代表的群体将因审判而异。对于一种类型的试验，服务不足的群体可能与另一种类型的试验非常不同。为什么一些研究没有包括服务不足的群体，原因可能很复杂，但如果从试验开始就考虑，解决纳入障碍的解决方案更容易确定。交叉性更进一步，承认可能有多种因素(例如种族和性别)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，我们必须考虑任何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、身体能力、移民身份等。最近开发了一些名为包含框架的工具(参见https://www.trialforge.org/trial-forge-centre/diversity/)，以帮助试验团队思考他们的设计决定如何可能使某些群体更容易或更难参与。每个框架都侧重于一个服务不足的个体群体。目前，有侧重于族裔、同意能力受损的成年人和处于社会经济不利地位的成年人，还有更多的正在发展中。然而，试验者可能会被可用的框架数量淹没，如果没有经过深思熟虑地考虑重叠，可能会错过小组之间存在的任何交叉性。这个项目的目标是为试验团队提供一个简化的过程，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未得到充分服务的群体之间存在交叉的地方，以及这对需要在设计试验时考虑这些群体的研究人员意味着什么。此外，该项目将考虑什么类型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面临的障碍和挑战。最后，该项目将调查可以为研究人员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，而且被付诸实施，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.