COVID-19 disproportionately effects BAME individuals, will they be proportionally represented in clinical trials?
The Government are launching an inquiry into the disproportionate impact of COVID-19 on BAME people, but will it ensure fair representation of these groups in UK clinical trials?
Following mounting pressure from the public and industry experts, Downing Street has announced a formal review into the reasons why COVID-19 appears to disproportionately affect people from black, Asian and minority ethnic (BAME) backgrounds in the United Kingdom. This was triggered by a study from the Intensive Care National Audit and Research Centre, which shows that BAME individuals accounted for 33.6% of patients infected with the virus despite accounting for just 14% of the population.
The potential reasons for this are complex; many have questioned the role played by genetic make-up (and thus different immune profiles and levels of comorbidities), social constructs, cultural identity and behavioural patterns, all of which can have fundamental impacts on the risk of infection and increased mortality rates in BAME communities. Other commentators suggest that the root of the problem lies in the prevailing health inequalities in the UK. As Joan Sadler OBE, from the NHS Confederation stated in her recent blog “we have long known that BAME communities have worse health outcomes, and it could be predicted that overlaying a new disease like COVID-19 will exacerbate existing inequities.”
Kye Lockwood , CEO of Social Action for Health states “Social Action for Health has been working with multi-ethnic communities in East London for over 30 years to address the impact of the health inequalities that are so deeply established within our society. The essential resources we need to thrive as people are unevenly distributed due to the wider social, political and economic factors which shape the conditions in which people are born, grow, live, work and age. Good health starts in our schools, communities and workplaces, so it should not be a surprise that the inequalities that start there can be seen in different health outcomes across ethnic groups. This pandemic has revealed the imbalance that has been present in our society for a long time; hopefully it will lead to a significant shift in the way health information, advice, services and research are delivered across our diverse communities in future.”
The Government’s review into COVID-19 is an encouraging start to expose these inequalities, but more needs to be done to activate improved public health policies as we move into a post-crisis era. This should involve an urgent review of the inequalities currently existing in medical research.
There are a number of clinical trials currently taking place in the UK, both to find a vaccine and a cure for COVID-19 (most notably The Recovery trial for treatment, and the Oxford University trial for a vaccine). Whilst there has been no reporting of the ethnic make-up of the participants of these specific trials, previous studies have shown that medical research vastly underrepresents BAME individuals. This feels especially perverse, given that the same community are statistically more susceptible to the very diseases being tested and would therefore have greater demand for the vaccine.
UK researchers are not currently required to account for ethnicity in trials, so the evidence on BAME participation is limited. However, statistics from the United States show that black people are twice as likely to die from prostate cancer than their Caucasian counterparts, but only represent 4% of prostate clinical trial participants. Cancer is the leading cause of death for the Asian–American population, yet Asian Americans represent less than 3% of clinical trial participants.
In a UK context, programmes such as INVOLVE, part of the National Institute for Health Research, and Equality Diversity and Inclusion in Science and Health (EDIS), exist to address this.
MHP wanted to better understand this, so we spoke with Dr Lilian Hunt, EDIS Programme Lead: “Where there is evidence that a particular group are disproportionately affected by a disease, such as the BAME community and COVID-19, it is crucial to design clinical trials that are representative of these populations. It’s also important to understand the true driver of any difference observed. For example social inequity often has a far greater impact than genetic ancestries on health inequalities, and any health interventions need to be developed with this framing.”
The reasons for the disproportionate participation in research are complex, but it is likely that consultant bias, poor communication about the benefits of trials across different channels to BAME individuals and underrepresentation of BAME people in STEM roles all play a part.
Individuals of all ethnicities should have equal opportunities for involvement in research, early access to vaccines and a potential cure. Research from the US Food and Drug Administration is found that medical products are safer and more effective for everyone when clinical research includes diverse populations, which will require a close examination of the genetic, social, cultural and behavioural diversities that could impact susceptibility to the virus.
UK researchers are doing phenomenal work to kick-start this research, and there is critical need for speed and efficacy at this time of crisis. Government and pharmaceutical companies alike should capitalise on the current climate and public interest in clinical trials to enrol people from traditionally hard-to-reach groups, creating better treatments as a result. This could be the moment where we choose to own up to the issues of inequality and set the standard for diversity and inclusion in medical research for the UK.