The results of trials will not have their full impact if part of the population is ignored or forgotten. Unfortunately, this is often the case for ethnic minority groups. We have recently developed a tool called the INCLUDE Ethnicity Framework (https://www.trialforge.org/trial-forge-centre/include/), which helps trial teams to think about how their design decisions might make it easy or difficult for participants from some ethnic groups to take part. Feedback so far has been very positive, and organisations that fund trials such as the National Institute for Health Research and the Wellcome Trust, now include it in their guidance for researchers.
We now want to go further. Firstly, we want to help trial teams using the Framework to identify the proportion of people from different ethnic groups needed for the trial to be truly representative. This will drive their recruitment targets and plans. Secondly, we want to give them evidence-based strategies to help them achieve these proportions. Doing this will reduce inequality and increase confidence that the results of an expensive trial will help all those who could benefit, including people from ethnic minority groups.
We have produced a list of eight recommendations to help trial teams think about how to decide which ethnic groups are needed for their trial. More information is at https://www.trialforge.org/trial-forge-centre/how-to-decide-which-ethnic-groups-your-trial-needs/
These are v1.0 of the recommendations and we’re releasing them because a) we think they might be useful but also b) because we are keen to get comments and feedback on them sooner rather than later. If you’d like to get in touch, contact us on email@example.com.
This project is funded by the Chief Scientist Office of the Scottish Government’s Health and Social Care Department and led by Prof Shaun Treweek at the University of Aberdeen.
- Shaun Treweek; firstname.lastname@example.org