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

Representation of the Black, Asian and minority ethnic (BAME) community in randomised trials is often poor. As we have seen in the news, the BAME community is disproportionately affected by COVID-19, which means it is essential that trials of treatments and vaccines for COVID-19 include people with BAME backgrounds. It is not clear that this is currently the case. Ongoing UK work looking at the design quality of global COVID-19 trials has found that just 1 of 9 published COVID-19 trials even mentions ethnicity. Of 1518 COVID-19 studies registered on ClinicalTrials.gov (the US registry of clinical trials), only six are currently collecting data on ethnicity. Considering ethnicity is not routine in trials.

This project will complete a tool (called the INCLUDE Ethnicity Framework) that trial designers can use to make sure they think about factors that affect BAME involvement 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 BAME communities.

We have already done some work without funding and this has included patient and public involvement from the BAME community. This proposal will use that feedback to finish the tool.

The disproportionate burden of COVID-19 on people with Black, Asian and minority ethnic (BAME) backgrounds makes it essential that randomised trials of treatments and vaccines include BAME participants. It is not clear this is happening.

Ongoing work by the MRC-NIHR Trial Methodology Research Partnership (TMRP) Statistics Subgroup on the rigour of global COVID-19 trials has found that only 1 of 9 published COVID-19 trials even mentions ethnicity. Of 1518 COVID-19 studies registered on ClinicalTrials.gov, only six are currently collecting data on ethnicity. The reasons for under-representation of BAME groups are complex and could be attributable to a lack of willingness on the part of participants or a lack of inclusion by health-care staff or researchers and other socioeconomic factors and entrenched structural inequalities. Design decisions such as limiting materials to English means over 40% of Bangladeshi and over 30% of Pakistani women over 65 in the UK cannot take part. Not considering culture, or the nature of the intervention and delivery are likely to exclude more.

In 2018 NIHR initiated INCLUDE, which will produce a general roadmap for better inclusion of many under-served groups in trials. In parallel, a collaboration between INCLUDE, Trial Forge and the MRC-NIHR TMRP has been developing the ethnicity component of INCLUDE. The ethnicity framework will help trialists to identify, recruit and retain the BAME representation needed in their trial for the results to be widely applicable to the entire population. There has been substantial BAME and PPI involvement already.

This proposal will rapidly complete the INCLUDE Ethnicity Framework and apply it to 3-5 trials (including COVID-19) to produce an example set for other trialists to use when planning future COVID-19 trials. It will also help people interpreting and reporting COVID-19 trials to make judgements about the applicability of trial results to BAME communities.