How biopharma companies can drive greater diversity in clinical trials

As we continue to examine the deep inequities in health and health care in the US, the racial and ethnic diversity of clinical trials is top of mind for industry stakeholders as well as the Food and Drug Administration (FDA) and other public health organizations. While health inequities have been illuminated by the pandemic over the past 18 months, the need to improve participation in clinical trials by Black and Latinx people, women, elderly people and other underrepresented groups has been understood for many years. 

In 2017, the National Institutes of Health (NIH) convened a group of leaders, as mandated by the 21st Century Cures Act, for a workshop on inclusion across the lifespan that resulted in two papers published in the Journal of the American Medical Association (JAMA).¹  The papers highlight gaps in trial participation by key groups, the impact that this has had in several key areas and the criticality of improving clinical trial diversity as a matter of public health. This work, along with growing prioritization of health equity issues overall, has pushed the biopharma industry toward innovation in clinical trial design. However, to drive lasting change and a more inclusive long-term approach to biopharma research and development, we must first understand why diversity in clinical trial enrollment is so important.

Current state of clinical trial diversity

Despite the disproportionate impact of conditions such as cancer, heart disease and diabetes on Black, Latinx and other vulnerable populations, most participants in biopharma studies and clinical research are of European ancestry. For example, one recent study reviewed 230 clinical trials in oncology over a recent 10-year period, finding that only 145 trials (63%) included any information about the participant’s race and only 18 (8%) broke down participants by race.² 

In addition, a 2018 data collation on clinical trials that led to FDA approvals between 1994 and 2014 revealed the median percentage of Black participants per trial ranged from 1.8% to 3.5%.³  For Asian participants, the range was 0% to 7%, and for any group unspecified or not described as White, Black or Asian, it was 1.4% to 3.4%.⁴ This is a nonrepresentative reflection of the population at large⁵ and skews even further from the actual burden of cancers by race.⁶

Similarly, today’s genomic databases primarily contain DNA samples from people of European ancestry. For instance, a 2019 study revealed that participation in genome-wide association studies, 78% of participants were European, 10% were Asian, 2% were African, 1% were Hispanic, and all other ethnicities represented less than 1%.⁷ Ultimately, this lack of diversity impairs objective analysis of drug efficacy in communities of color and impedes our understanding of the influence of genetics on disease management. 

There is also an acute need for biopharma to understand specific nuances around how some conditions manifest in patients of color. This creates greater institutional awareness around the social determinants of health (i.e., the economic, environmental and social conditions that impact health) and has the potential to help drive better health for underrepresented populations as researchers uncover nuanced information on the differential impact of novel treatments in different races, communities and ethnicities. Examples of these nuances include but are not limited to the following:

• Even though asthma is the most common chronic childhood disease in the world,⁸  disproportionately affecting Black, Puerto Rican and Native American people,⁹ drug trials conducted to demonstrate the efficacy of asthma treatment have not adequately represented the populations most impacted by the disease.¹⁰ In the US, Black and Puerto Rican children — who also have the highest prevalence of asthma nationwide — respond least well to lifesaving asthma medications such as albuterol and experience higher rates of hospitalization, poorer health outcomes and more deaths.¹¹ There are many underlying causes for these disparities, but recent studies demonstrate that genetic risk factors are linked to higher rates of asthma and poor response to bronchodilator medications in these populations.¹²
  
  
• Systemic lupus erythematosus (SLE) is an autoimmune disease that affects the skin, joints and several other organs. SLE also disproportionately impacts Black, Latinx and Asian patients, who are at increased risk of developing severe manifestations from the disease.¹³  Despite this fact, there is insufficient medical literature describing the manifestations of SLE (and other skin diseases such as psoriasis and atopic dermatitis) on pigmented skin. For example, a 2018 study found that just 4.5% of images in medical textbooks showed disease manifestations on dark skin.¹⁴ Hence, most medical and nursing students, along with many experienced clinicians, are unaware of how these skin diseases affect entire populations. This impedes clinicians’ ability to effectively diagnose and treat skin diseases in people with pigmented skin, augmenting delayed or missed diagnoses and adverse outcomes in this demographic.¹⁵
  
  
• The incidence rate for inflammatory bowel disease (IBD), a chronic gastrointestinal condition, is rising three times faster among Asian, Latinx and Black patients than among White patients.¹⁶ Studies demonstrate that Black IBD patients tend to be diagnosed later, are less likely to receive recommended biologics and immunomodulators, and are less likely to be referred to a specialist, resulting in more serious consequences from the disease.¹⁷ The relevant literature suggests that these clinical trials have not comprised the racial and ethnic diversity needed to enable a better understanding of the efficacy of approved IBD drugs in Asian, Latinx and Black patients, since most published studies on the epidemiology and progression of IBD in the US were performed with predominantly White participants.¹⁸