Ensuring that COVID-19 trials consider ethnicity: the INCLUDE Ethnicity Framework for randomised trials
- Funded by Department of Health and Social Care / National Institute for Health and Care Research (DHSC-NIHR), UK Research and Innovation (UKRI)
- Total publications:1 publications
Grant number: MR/V020544/1
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Key facts
Disease
COVID-19Start & end year
20202020Known Financial Commitments (USD)
$9,785.94Funder
Department of Health and Social Care / National Institute for Health and Care Research (DHSC-NIHR), UK Research and Innovation (UKRI)Principal Investigator
PendingResearch Location
United KingdomLead Research Institution
University of AberdeenResearch Priority Alignment
N/A
Research Category
Therapeutics research, development and implementation
Research Subcategory
Therapeutic trial design
Special Interest Tags
N/A
Study Type
Clinical
Clinical Trial Details
Randomized Controlled Trial
Broad Policy Alignment
Pending
Age Group
Unspecified
Vulnerable Population
Minority communities unspecified
Occupations of Interest
Unspecified
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.
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