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Aberdeen Centre for Evaluation

INCLUDE Ethnicity Framework: Ensuring that COVID-19 trials consider ethnicity

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INCLUDE Ethnicity Framework: Ensuring that COVID-19 trials consider ethnicity

Representation of ethnic minority communities in randomised trials is often poor. 聽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. 聽It is not clear that this is currently the case.聽聽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.聽聽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 聽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. 聽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. 聽The INCLUDE Ethnicity Framework will be equally useful for helping to make sure that non-COVID trials consider ethnicity too. 聽

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).

Contacts

Status

Completed

Publications

Related publications

Treweek S, Forouhi NG, Narayan KMV, Khunti K. COVID-19 and ethnicity鈥� who will research results apply to? Lancet 2020, June 12th.

Dawson聽S, Banister聽K, Biggs聽K聽et al. Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups鈥攑ractical guidance to support better practice. Trials 23, 672 (2022).

A publication against the INCLUDE Framework

Treweek, S., Banister, K., Bower, P. et al. Developing the INCLUDE Ethnicity Framework鈥攁 tool to help trialists design trials that better reflect the communities they serve. Trials 22, 337 (2021).