In the fast-paced medical research and innovation industry, clinical trials serve as the bedrock for advancing our understanding of diseases and developing groundbreaking treatments. However, as we celebrate the strides made in modern medicine, it is crucial to acknowledge and address the persistent issue of health disparities within the framework of clinical trials. Different people experience the same disease differently.
Clinical trials need to involve a variety of people so that the data collected is representative of the population intended to benefit from a treatment. Historically, clinical trials were conducted on almost exclusively white, male participants. This has created bias within clinical trial data, including gaps in our understanding of disease and drugs at both a population and individual level.
So, what can the clinical trials industry do to get to the bottom of these health disparities and ensure that drugs and treatments are developed equitably for everyone?
Overview
Statistics tell a story.
In the UK, one in eight men will be diagnosed with prostate cancer in their life; if you are a Black man, then you have a one in four chance of being diagnosed. So, Black men are more likely to be diagnosed with prostate cancer, potentially for genetic and biological reasons. But even with this higher likelihood, a number of socio-economic, geographical and cultural factors may deter, prevent or intimidate Black men from getting the diagnosis and the quality treatment they need.
Let’s move to another statistic. Black women are four times more likely to die in pregnancy or childbirth than white women; women from Asian ethnic backgrounds face a twofold risk. Once again, on both sides of the Atlantic, high profile public figures such as Serena Williams and Candice Braithwaite shared the complications and racial biases they experienced during childbirth. Similarly to rates of prostate cancer in men, a swathe of medical and socio-economic factors could contribute to the poor and potentially life-threatening experience of pregnancy for Black women.
And then there is one of the most commonly known cases of health disparities divided along the lines of race and ethnicity that researchers continue to investigate: the disproportionately high cases of sickle cell anaemia for people of African and African-Caribbean heritage. Sickle cell predominates across the African continent, but also continues to affect lives in the UK.
The passing of Chadwick Boseman in 2020 sent ripples through the entertainment industry and left fans of the record-breaking 2018 Black Panther movie in shock. Chadwick died of colon cancer at the age of just 43. Earlier this January, CNN anchor Sara Sidner shared that she had stage 3 breast cancer, and urged women to get their mammograms every year.
She dutifully highlighted the statistic, that if you are a Black woman, you are 41% more likely to die from breast cancer than white women. In the wake of Chadwick’s death, the American Cancer Society drew attention to the disproportionate realities that African-American men are 20% more likely to get colorectal cancer than their white counterparts, and 40% more likely to die from the disease.
On both sides of the Atlantic and around the globe, who, exactly, can access cancer care is fraught with racial disparities. As clinical trials researchers, educators and professionals working across healthcare industries, many of us are asking ourselves: what is to be done?
Behind every statistic, there are the stories of mothers, fathers, brothers, aunties and more who are not only at heightened risk of contracting certain diseases and morbidities, but who also have to grapple with healthcare systems that fail to deliver the best treatment. Behind those healthcare systems is a much deeper history.
Certainly, there is a dark history when it comes to the relationships between global health, genetics and genomics, clinical research and their proximity to racial disparities and racism. It goes without saying that we have come a long way from the unscientific ideas you’d find in 19th century medicine and science. Nevertheless, that doesn’t mean we are immune to residual, biased beliefs in differences between people based on race. As recent research in the US showed, healthcare providers carried assumptions about a higher pain tolerance for Black people.
While we might wish to think that clinical and scientific research is entirely objective, the reality, evident in both present and past situations, along with statistics, suggests otherwise. Whether we're professionals in clinical trials, geneticists or pharmacologists, our research is intertwined with the legacies of a complex history. This history continues to influence health inequalities today, impacting aspects like the flawed design of clinical trials, the absence of unconscious bias training for professionals, and the demographics shaped by Commonwealth and Windrush histories.
We’ve inherited a mammoth task to develop interventions and solutions that will create a more equitable health landscape for people of colour. This we must do if we are to prevent premature losses.
We hope that the compelling statistics and enlightening medical histories collectively ignite a positive conversation about health disparities. Most importantly, we believe they can serve as catalysts for meaningful change.
The world of clinical trials and research is bringing incredibly exciting new treatments, medicines and drugs to market that could mean we can tackle the mortality rates for breast and prostate cancer, as well as sickle cell amongst Black populations, and provide improved experiences and outcomes for Black pregnant women.
However, as we’ve discussed in depth here, if clinical trials professionals lack this awareness when they are designing their research, or translational research fails to engage with the structural barriers that prevent a diverse take-up for their trials, then interventions, solutions and treatments could fail the people who need them the most.
Fortunately, change is happening; perhaps not fast enough, but it’s on its way. In November of 2023, the US Food and Drug Administration (FDA) hosted a two-day workshop to enhance the diversity of clinical research. This workshop – which brought together clinical research organisations with industry academics, regulator agencies and many more – yielded some important insights, including the structural barriers to accessing clinical trials, the utility of personalised screenings for breast cancer, and the need to more purposefully foster relationships between community and faith-based organisations and healthcare systems.
Certainly, some positive steps to be celebrated! However, more needs to be done to improve the diversity of clinical trial populations. More than a box-ticking exercise, diverse clinical trials can yield significant results for the efficacy of certain drugs and treatments that are brought to market, as well as the confidence Black people have in receiving them. Acknowledgment of this also led the FDA to publish their 2020 document on enhancing the diversity of clinical trials populations, which you can read here.
At CGX, our mission is to train the next generation of clinical trials professionals to the highest standards, and work alongside institutions and companies to ensure their staff and research projects are as effective and robust as possible. With our consultancy service, Clinnovate, we’ll ensure that you are equipped to tackle health disparities and outcomes in your clinical research head-on. If you’d like to find out more, we’d love to talk to you. Don’t hesitate to contact us today.
