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

  • Start & end year

  • Known Financial Commitments (USD)

  • Funder

    Department of Health and Social Care / National Institute for Health and Care Research (DHSC-NIHR), UK Research and Innovation (UKRI)
  • Principle Investigator

  • Research Location

    United Kingdom, Europe
  • Lead Research Institution

    University of Aberdeen
  • Research Category

    Therapeutics research, development and implementation

  • Research Subcategory

    Therapeutic trial design

  • Special Interest Tags


  • Study Subject


  • Clinical Trial Details

    Randomized Controlled Trial

  • Broad Policy Alignment


  • Age Group


  • Vulnerable Population

    Minority communities unspecified

  • Occupations of Interest



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.

Publicationslinked via Europe PMC

Last Updated:38 minutes ago

View all publications at Europe PMC

Developing the INCLUDE Ethnicity Framework-a tool to help trialists design trials that better reflect the communities they serve.