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

Lead Research Organisation: University of Aberdeen
Department Name: Sch of Medicine, Medical Sci & Nutrition

Abstract

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.

Technical Summary

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.

Publications

10 25 50
 
Title INCLUDE Ethnicity Framework 
Description 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. 
Type Of Material Improvements to research infrastructure 
Year Produced 2020 
Provided To Others? Yes  
Impact The INCLUDE Ethnicity Framework is now signposted with guidance for trialists applying for funding with the UK's National Institute for Health Research and Wellcome, and the Belgian funder of trials KCE. 
URL https://www.trialforge.org/trial-forge-centre/include/
 
Description Improving representation in trials: thinking more carefully about who should be in your trial 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact This talk was part of the MRC-NIHR Trials Methodology Research Partnership Annual meeting on 17th November 2020.
Year(s) Of Engagement Activity 2020
 
Description Interview for Scottish TV 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact An interview for Scottish TV about the participation of ethnic minority groups in COVID trials.
Year(s) Of Engagement Activity 2020
 
Description Making trials more inclusive- the INCLUDE Ethnicity Framework 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact This was a talk to Derby Clinical Trials Unit about the INCLUDE Ethnicity Framework, how it can help teams to think more carefully about which ethnic groups need to be in their trials and why this is important.
Year(s) Of Engagement Activity 2020
 
Description The INCLUDE Ethnicity Framework 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact This talk was given at the European Clinical Research Infrastructure Network (ECRIN) January 2021 scientific meeting to present and discuss the Include Ethnicity Framework in the UK/Ireland. This is part of efforts to further develop the framework for use in other European countries.
Year(s) Of Engagement Activity 2021
 
Description Thinking about ethnicity when designing your trial: have you done enough (or anything)? 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact This was a presentation at the Cardiff University Centre for Trials Research's symposium.

The 2020 annual symposium will have the theme 'Innovative Methods for Intervention Studies in Health Services Research'. The talk discussed how the INCLUDE Ethnicity Framework can help to identify the ethnic groups needed in a trial, as well as challenges the trial intervention and design might present for involving all the groups needed.
Year(s) Of Engagement Activity 2020