Resources for inclusive trials
This table provides some resources to support the design of trials that are inclusion, which in turn means they are likely to be more informative.
Resources for inclusive trials | |
Addressing the lack of representation in trials | INCLUDE project outlines groups that are currently underserved by clinical research |
Core characteristics for trials reporting | PRO EDI is a tool based on PROGRESS-PLUS, outlining six core characteristics that must be included in a clinical trial, and further characteristics that may be additionally required. PRO EDI guidance gives practical support to ensure trial reporting is done in an inclusive way. It is signposted to by Cochrane and mandated by Trials journal. |
Sex and Gender | Message The MESSAGE (Medical Science Sex and Gender Equity) project aims to improve integration of sex and gender considerations across data, analysis and reporting in biomedical, health and care research in the UK. SAGER a collaborative group of experts from the European Association of Science Editors (EASE) developed the Sex and Gender Equity in Research (SAGER) guidelines, “a comprehensive procedure for reporting of sex and gender information in study design, data analyses, results and interpretation of findings.” Van Epps et al., 2022 |
Ethnicity | STRIDE The STRIDE project brought together various stakeholdesr and led to eight recommendations for teams designing trials to include ethnic groups. INCLUDED The INCLUsivity through improving the practice anD utility of Ethnicity Data collection in trials (INCLUDED) project looked at how data on ethnicity are collected and handled in clinical trials, what those from diverse ethnic groups think about this, whether this has any bearing on their participation in research, and how data collection and handling could be improved. INCLUDE Ethnicity Framework The INCLUDE Ethnicity Framework helps teams think carefully about which ethnic groups need to be included for its results to be widely applicable. The framework also guides teams to consider the challenges that will need to be overcome. Having identified challenges, the team can then consider ways to overcome these. Ethnicity is a complex matter and influences personal identity and group social relations. The framework comprises 4 key questions and worksheets for trial teams plus PPI partners to work through together. |
Impaired Capacity and Communication | INCLUDE Impaired Capacity to Consent Framework A tool for researchers to ensure that their trial is designed to be inclusive of people with impaired capacity to consent, as well as improving the quality of the trial design and funding application. Key questions with worksheets help teams plan for successful inclusive trials. OPTIMISE The OPTIMISE recommendations help to achieve more inclusive participation for those who experience communication and/or decision-making difficulties and are often excluded from research. |
Socioeconomic Disadvantage | INCLUDE Socioeconomic Disadvantage Framework A framework to aid researchers, who are designing clinical trials, to consider barriers to including participants from socioeconomically disadvantaged backgrounds in their trial. The tool uses key questions and worksheets to prompt researchers to consider many aspects that could form barriers to participation. Trial Forge summary of Price et al., 2021, a paper outlining challenges and solutions or improving clinical trial enrolment of participants with low socioeconomic status. The Health Foundation A collection of resources on factors impacting health inequalities through socioeconomic impacts. |
Older People | Trial Forge summary of Goodwin et al., 2023, a paper developing a set of recommendations to guide all research relevant to older people. |
Trauma & Resilience | Trial Forge summary of Edelman, 2022, a paper outlining research principles and practice for better inclusion of disadvantaged populations using a trauma and resilience informed approach. UK Government resource for trauma informed practice (UK Government, 2022) including further reading. Trauma informed guidance for working together with PPI (Imperial College, 2024). |
Intersectionality | What is Intersectionality in Trials? Intersectionality is a concept that can help us to understand that “multiple forms of inequality or disadvantage sometimes compound themselves and create obstacles that often are not understood among conventional ways of thinking.” (Kimberlé Crenshaw). This video explains how intersectionality impacts participation in a trial, from the perspective of Alan, whose life does not fit neatly into one category. The Intersectionality Action Matrix was developed as a practical planning tool. It can help you to:
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