Topic
Date published
13/01/2021
It comes following damming reports indicating extremely low levels of people from ethnic communities in clinical research generally as well as in coronavirus studies, with a study published in June 2020 finding that of 1,518 COVID-19 studies registered on ClinicalTrials.gov, only six collected data on ethnicity. This despite the role of ethnicity becoming apparent very early in the pandemic.
In response, the INCLUDE Ethnicity Framework has been developed, which provides researchers with a blueprint for ensuring involvement of all ethnic groups in scientific studies. Now, the leaders behind the framework are calling for its widespread adoption.
The INCLUDE Ethnicity Framework was part of a group of projects which formed part of a rolling call for research proposals on COVID-19, jointly funded by UK Research and Innovation and National Institute for Health Research (NIHR) in response to the pandemic, and included research on treatments, vaccines and the spread of the virus, as well as specific calls on COVID-19 and ethnicity, and the wider impact of the virus on mental health.
Professor Shaun Treweek is Professor of Health Services Research in the Health Services Research Unit at the University of Aberdeen, and leads the Trial Forge initiative, which has led the development of the framework.
He said: “This is a tool that trial designers together with patient and public partners can use to make sure they think about factors that affect the involvement of all ethnic groups, such as disease, culture, the treatment being tested and trial information and procedures.
“It will also help people interpreting and reporting all trials, including COVID-19 trials, to make judgements about the applicability of trial results to all communities. This is particularly important for ethnic minority groups, which are very often under-represented in, and under-served by, health research.”
The Centre for BME Health, based in Leicester, and ARC East Midlands, were also behind the formation of the framework.
Professor Kamlesh Khunti, Director of NIHR ARC East Midlands and the Centre for BME Health, said: “There has been a stark absence of people from ethnic minorities from clinical trials. This new framework is about ensuring researchers have the tools, opportunity and understanding of what is required to ensure research is more reflective of society. We are now urging researchers to make use of this important framework.”
Adepeju Oshisanya is an AI Ethics & Data Diversity Advocate and Clinical Drug Development Leader at BenevolentAI and has also played a key role in developing the framework from a patient perspective.
She said: “These are pretty fundamental questions around the data being used to power new medical advances, innovations and treatments. Unfortunately, this data is flawed. And I don’t mean a little bit flawed.
“The data on which we’re basing innovation in our healthcare system is not reflective of the global population. Not even nearly. For example, 81% of participants in genome-wide association studies are of European descent. Whilst efforts are increasing to diversify the global genome data pool, more is needed, and fast.
“However, now with this new framework there is no excuse, researchers should no longer sit in a bubble, they can design a trial with an understanding of BAME communities.”
The Centre for BME Health is working to reduce health inequality in the region by sharing resources and promoting research. The Centre is supported by the University of Leicester and ARC East Midlands. NIHR ARC East Midlands is a partnership of regional health services, universities and industry which turns research into cost-saving and high-quality care through cutting-edge innovation.