Trial teams need to do everything possible to make their trial relevant to the people for whom the results are intended to apply (often patients) and those expected to apply them (often healthcare professionals).
The INCLUDE Ethnicity Framework aims to help trial teams think carefully about which ethnic groups should be included in their trial for its results to be widely applicable, and what challenges there may be to making this possible. Having identified potential challenges, the trial team can then consider ways to reduce those challenges. For this to work best, the Framework needs to be used at the trial design stage before funding is in place.
INCLUDE is an initiative from the UK’s National Institute of Health Research (NIHR) that aims to improve trial delivery for under-served groups. This will improve the applicability of the trial results and be in line with Principle 13 of the Declaration of Helsinki (‘Groups that are underrepresented in medical research should be provided appropriate access to participation in research.’)
Read a blog on INCLUDE– The forgotten, the ignored and the under-served – trials cannot continue to fail large parts of society. A pre-print describing how the INCLUDE Ethnicity Framework was developed is also available. The article is currently being reviewed by the journal Trials.
Four Key Questions and worksheets
The INCLUDE Ethnicity Framework has four Key Questions, each of which is intended to prompt trial teams to think about who should be involved as participants, and how to facilitate their involvement as much as possible. These questions should be considered by trial teams in partnership with patient and public partners.
Answering the Key Questions can be tricky. To help with this we have developed some worksheets that give pointers to the sort of things to think about when answering the Questions.
The Key Questions and worksheets can be downloaded from the links below.
The INCLUDE Ethnicity Framework
We have prepared some examples by applying the Framework to some existing trials. These examples are intended to be illustrative and not a definitive assessment of the trials. For the most part we were not involved with the trials so only had publicly available information with which to complete the worksheets. Moreover, doing this retrospectively rather than at the design stage is not ideal.
Hopefully though they will make it easier to see how the Framework can help identify potential problems with regard to involving the appropriate ethnic groups in a trial.
We would be delighted to add your examples to this list, or receive comments on the ones already listed. Contact us at firstname.lastname@example.org.
Currently we have six examples:
- By Band Sleeve (bariatric surgery)
- COVAC 1 (COVID-19 vaccine)
- iQuaD (periodontal disease prevention)
- PRINCIPAL (COVID-19 treatment)
- RECOVERY (COVID-19 treatment)
- TriMaster (type 2 diabetes treatment)
The INCLUDE Ethnicity Framework is new and we thought some insights from people who have used it might be useful.
Slides sets and materials for presentations
Funders and others signposting researchers to INCLUDE and the Ethnicity Framework
Below we list some resources which we hope you might find useful:
Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process
Participants in clinical research studies often do not reflect the populations for which healthcare interventions are needed or will be used. This article describes a multicomponent project – called INCLUDE –to improve representation of under-served groups in clinical trials.
This guidance summarises what an under-served group is, a roadmap suggesting intervention points to improve inclusion, examples of under-served groups and example barriers to inclusion. It also has examples of good practice and other resources to guide teams seeking to engage with, and improve inclusion of, under-served groups in clinical research.
Increasing participation of Black Asian and Minority Ethnic (BAME) groups in health and social care research
This toolkit aims to capture best practice and provide researchers with a framework on how to improve the participation of minority ethnic groups in research.
This white paper from Couch Health– recruiting diverse populations for clinical studies – guides you through important considerations you need to make to help make the process more accommodating for everyone.
The NIHR Clinical Research Network’s COVID-19 Vaccine Research Delivery Group ran this community consultation to support the understanding and thus delivery of the COVID-19 vaccine studies.
This work been a collaboration between Trial Forge, INCLUDE and the following networks and groups.