Despite global recognition that diversity within population studies is poor, clinical trials for current treatments and vaccines for COVID-19 still fall short.
Since its emergence, increasing evidence has emerged highlighting the disproportionate effects COVID-19 is having on minority communities. Therefore, it is alarming to find out that clinical trials for COVID-19 have so far failed to enrol diverse populations that actually reflect society.
A recent STAT podcast – “The Readout LOUD” – discusses issues of diversity and inclusion in COVID-19 clinical trials. The team were joined by Dr Hala Borno, oncologist at the University of California, San Francisco. Borno has been studying the gap between real-world demographics and clinical trial enrolment.
Lack of reporting
Borno discusses a recent article, published in Contemporary Clinical Trials Communications, which she co-authored. This study sought to assess the race reporting and representation among US COVID-19 therapeutic studies to date. They found that a third of studies did not report race or ethnicity data. They also discovered a significant underrepresentation of black patients in all studies.
The authors urged that investigators should uniformly report race and attempt to obtain representativeness among participants in order to avoid widening the treatment gap. In the podcast, Borno rightly described this as “outrageous”. We are in the year 2020, and investigators are failing to even collect or report race/ethnicity data in published research.
The risk
The purpose of clinical trials is to try and determine whether the intervention is effective and safe. Without the recruitment of patients, the important signals of efficacy or toxicity would be missed, which could have devastating effects. If diversity is not represented in these clinical trials, then the potentially diverse effects of the therapy may not be captured until it is too late.
Borno states:
“I think that if we do not ensure diversity in these COVID-19 clinical research studies, we may ultimately render interventions, whether it be drug or vaccines, that do not uniformly demonstrate efficacy across populations, or have side effects that we only capture later on.”
Long history of injustice
There are several barriers to participation among minority groups. This includes awareness, access and lack of trust in medical establishments due to a long history of injustice. Borno expresses that it is important to think about these factors when recruiting individuals to clinical trials. However, she argues that a lot of data out there reveals how ethnic minorities actually show a great interest in participating in clinical research when offered.
Borno states:
“We should acknowledge our history of exploitation in experimental research is horrific and we should learn lessons from it. But we should not prevent it from offering diverse populations opportunities for clinical research.”
Broken promises
Leaders and researchers have set up several initiatives and international efforts to encourage diversity and inclusion. Borno gives the 1993 NIH Revitalization Act as an example. This act required the inclusion of women and ethnic minorities in publicly funded clinical trials. However, Borno highlights how this mandate did not come with a clear protocol or guidance on how to achieve this.
Borno emphasises that, in reality, it is challenging to hold investigators accountable for promises regarding the importance of enrolling diverse populations in large-scale COVID-19 studies. However, she makes it clear that investigators should ensure they uniformly collect and report data on race/ethnicity.
It is now, more than ever, important to ensure that diverse populations are represented in research and clinical trials. Investigators must conduct these in an ethical manner. This involves building relationships with local researchers, considering cultural concerns and obtaining valid consent. It is essential that the promises of ensuring representation and equity in science are not empty.
Originally posted on D4 Pharma.
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