Representation of ethnic minority communities in randomised trials is often poor. As we have seen in the news over the last year, people with ethnic minority backgrounds have been disproportionately affected by COVID-19, which means it is essential that trials of treatments and vaccines for COVID-19 include diverse populations. It is not clear that this is currently the case. A review in June 2020 found that of 1518 COVID-19 studies registered on ClinicalTrials.gov, a register of trials, only six were collecting data on ethnicity. Considering ethnicity is not routine in trials.
This project has completed a tool (called the INCLUDE Ethnicity Framework) that trial designers together with patient and public partners can use to make sure they think about factors that affect the involvement of all ethnic groups such as disease, culture, treatment being tested and trial information and procedures. It will also help people interpreting and reporting COVID-19 trials to make judgements about the applicability of trial results to all those in our communities, not just some of them. The INCLUDE Ethnicity Framework will be equally useful for helping to make sure that non-COVID trials consider ethnicity too.
The INCLUDE work to improve our understanding of the links between COVID-19 and ethnicity has been funded by UK Research and Innovation (UKRI) and the National Institute for Health Research (NIHR).
- Shaun Treweek; firstname.lastname@example.org
Treweek S, Forouhi NG, Narayan KMV, Khunti K. COVID-19 and ethnicity– who will research results apply to? Lancet 2020, June 12th. https://doi.org/10.1016/S0140-6736(20)31380-5
Dawson S, Banister K, Biggs K et al. Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups—practical guidance to support better practice. Trials 23, 672 (2022). https://doi.org/10.1186/s13063-022-06553-w
A publication against the INCLUDE Framework
Treweek, S., Banister, K., Bower, P. et al. Developing the INCLUDE Ethnicity Framework—a tool to help trialists design trials that better reflect the communities they serve. Trials 22, 337 (2021). https://doi.org/10.1186/s13063-021-05276-8