8 minute read 21 Aug 2021

By accelerating representative diversity in clinical trial enrollment, biopharma companies enable better patient outcomes and promote growth.

Multiethnic people sitting in doctors office

How biopharma companies can drive greater diversity in clinical trials

Authors
Yele Aluko MD, MBA

EY Americas Chief Medical Officer

Proven MD/MBA physician executive and corporate leader with astute clinical and business healthcare industry expertise and insight.

Susan Garfield, DrPH

EY Americas Chief Public Health Officer and Global Client Service Partner

Health and life sciences strategist. Helps companies transform businesses and leverage technologies. Public health leader. Addresses health equity issues and builds better public health resilience.

Namrita Negi

Assistant Director, EY Knowledge, Ernst & Young LLP

Experienced life sciences industry analyst. Passionate about health equity. Certified Professional Coach.

Contributors
8 minute read 21 Aug 2021

By accelerating representative diversity in clinical trial enrollment, biopharma companies enable better patient outcomes and promote growth.

In brief

  • The COVID-19 vaccine trials have demonstrated the efficacy of diverse enrollment, but there is still much work to be done.
  • Many conditions require a more nuanced approach during the R&D process because of how they manifest in various patient populations.
  • Taking steps now to drive greater inclusion in clinical trials can help close health equity gaps and create new revenue opportunities.

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

Practices are starting to change, but much work still needs to be done

In one promising example, the COVID-19 vaccines with emergency use authorization from the FDA have demonstrated that diverse enrollment in clinical trials is both possible and effective.¹⁹ By developing these vaccines with greater racial and ethnic diversity among clinical trial subjects from the very beginning, biopharma and government stakeholders have achieved a more accurate representation of the actual US population among trial participants. The scientific benefits of this approach, which drives both economic and societal value, cannot be overstated. 

Along with biopharma companies, the Pharmaceutical Research and Manufacturers of America (PhRMA), NIH and FDA have recently taken significant steps to enhance racial and ethnic diversity in clinical trials.²⁰ These measures include developing guidance to drive more inclusive research and promote relationship-building in underserved communities. For example, one biopharma company has created a clinical trial diversity alliance “to advance the representation of diverse patient populations in the company’s oncology clinical trials, test recruitment and retention approaches, and establish best practices that can be leveraged across the industry to help achieve health equity for people with cancer.”²¹ Adopting and scaling these strategies across all drugs and therapeutics is essential to enhance the positive impact these therapeutics are designed to achieve. 

The path forward

Biopharma organizations need to continue to prioritize initiatives that address health equity, with improving clinical trial participation and recruiting being a critical starting point. 

There are three key actions that will help drive this effort: 

1. Focus on creating a culture of equity and inclusion across your business 

  • Prioritize diversity, equity and inclusion (DEI) principles and competencies across all functions within the business to facilitate greater understanding of the cultural nuances that enable effective, diverse clinical trials and inform evidence-based treatment for all racial and ethnic groups 
  • Develop specific goals and compliance metrics for diverse representation in all self-sponsored clinical trials that seek to inform efficacy of new therapeutics across all races and ethnicities 
  • Invest in strategies that drive more diverse genomic databases and collaborate with leaders in academia to develop precision medicine for at-risk and understudied populations

2. Challenge partners to prioritize DEI-related goals

  • Devise communication strategies to set expectations for diverse clinical trial enrollment at all partnering clinical trial site organizations 
  • Provide investigators and clinicians with resources and content to mitigate biases in the development and/or administration of clinical trials 
  • Create customized content for communities of color that promotes the safety, benefits and value of diverse clinical trial enrollment 

3. Leverage technology

  • Use artificial intelligence and machine learning to mine structural, social, biological and behavioral population data to identify larger portfolios of diverse candidates that meet criteria for clinical trials
  • Utilize digital platforms to connect more diverse participants with clinical trial sites and investigators, and electronically track real-time enrollment at clinical trial sites to drive visibility and accountability for diverse participation 
  • Show references#Hide references

    [1] “Improving Public Health Requires Inclusion of Underrepresented Populations in Research,” JAMA Network website, https://jamanetwork.com/journals/jama/article-abstract/2667821, accessed 3 August 2021; “Inclusion Across the Lifespan,” JAMA Network website, https://jamanetwork.com/journals/jama/article-abstract/2703925, accessed 3 August 2021.

    [2] “Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018,” JAMA Network website, https://jamanetwork.com/journals/jamaoncology/fullarticle/2748395, accessed 3 August 2021.

    [3] “When will clinical trials finally reflect diversity?,” Nature website, https://www.nature.com/articles/d41586-018-05049-5?WT.ec_id=NATURE-20180510&utm_source=nature_etoc&utm_medium=email&utm_campaign=20180510&spMailingID=56589675&spUserID=MjA1NzcwMjE4MQS2&spJobID=1401532263&spReportId=MTQwMTUzMjI2MwS2, accessed 3 August 2021.

    [4] Ibid.

    [5] Ibid.

    [6] “Cancer Disparities,” National Cancer Institute website, https://www.cancer.gov/about-cancer/understanding/disparities, accessed 3 August 2021.

    [7] “The Missing Diversity in Human Genetic Studies,” Cell website, https://www.cell.com/cell/fulltext/S0092-8674(19)30231-4, accessed 3 August 2021.

    [8] “Asthma and Children Fact Sheet,” American Lung Association website, https://www.lung.org/lung-health-diseases/lung-disease-lookup/asthma/learn-about-asthma/asthma-children-facts-sheet, accessed 3 August 2021.

    [9] “Current Asthma Demographics,” American Lung Association website, https://www.lung.org/research/trends-in-lung-disease/asthma-trends-brief/current-demographics, accessed 3 August 2021.

    [10] “Demographic data in asthma clinical trials: A systematic review with implications for generalizing trial findings and tackling health disparities,” NIH website, https://pubmed.ncbi.nlm.nih.gov/19592148/, accessed 3 August 2021.

    [11] “Genomic Analysis Reveals Why Asthma Inhalers Fail Minority Children,” University of California San Francisco website, https://www.ucsf.edu/news/2018/03/410041/genomic-analysis-reveals-why-asthma-inhalers-fail-minority-children, accessed 3 August 2021.

    [12] Ibid.

    [13] “Update on lupus epidemiology: advancing health disparities research through the study of minority populations,” National Institutes of Health (NIH) website,  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6791519/, accessed 30 June 2021.

    [14] “Representations of race and skin tone in medical textbook imagery,” ScienceDirect website, https://www.sciencedirect.com/science/article/abs/pii/S0277953618300790?via%3Dihub, accessed 30 June 2021.

    [15] Ibid.

    [16] “Rising IBD rates in minorities heighten need for awareness, strategies to close treatment gaps,” MDedge website, https://www.mdedge.com/gihepnews/article/231714/ibd-intestinal-disorders/rising-ibd-rates-minorities-heighten-need, accessed 30 June 2021.

    [17] “Racial disparities in utilization of specialist care and medications in inflammatory bowel disease,” NIH website, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3170037/, accessed 30 June 2021.

    [18] “Effects of Race and Ethnicity on Diagnosis and Management of Inflammatory Bowel Diseases,” Gastroenterology website, https://www.gastrojournal.org/article/S0016-5085(20)35312-9/fulltext, accessed 30 June 2021.

    [19] “Racial Diversity within COVID-19 Vaccine Clinical Trials: Key Questions and Answers,” Kaiser Family Foundation website, https://www.kff.org/racial-equity-and-health-policy/issue-brief/racial-diversity-within-covid-19-vaccine-clinical-trials-key-questions-and-answers/, accessed 15 July 2021.

    [20] Ibid.; “Just released: PhRMA members’ new clinical trial diversity principles,” PhRMA website, https://catalyst.phrma.org/just-released-phrma-members-new-clinical-trial-diversity-principles?_gl=1*aasvfw*_gcl_aw*R0NMLjE2MjYzNzA2MzEuQ2owS0NRand1Yi1IQmhDeUFSSXNBUGN0cjd3dW9qUW9MRTVaWjZtSzZTUkFKcWpPdGhnd0R2WnptektZUHY3YktMQWtYNFQyTU1iTE11b2FBdUt0RUFMd193Y0I, accessed 15 July 2021.

    [21] “Genentech Launches Oncology Clinical Trial Diversity Alliance,” Genentech website, https://www.gene.com/media/statements/ps_062321?sf145128570=1, accessed 3 August 2021.

Summary

To drive drug approval for therapeutics that benefit all populations, biopharma companies must commit to more strategic participation that enables diverse, representative enrollment in their clinical trials. Aligning on this imperative by redesigning clinical trial business models that drive equal therapeutic value throughout the diversity of humanity will deliver equitable health outcomes for us all.

About this article

Authors
Yele Aluko MD, MBA

EY Americas Chief Medical Officer

Proven MD/MBA physician executive and corporate leader with astute clinical and business healthcare industry expertise and insight.

Susan Garfield, DrPH

EY Americas Chief Public Health Officer and Global Client Service Partner

Health and life sciences strategist. Helps companies transform businesses and leverage technologies. Public health leader. Addresses health equity issues and builds better public health resilience.

Namrita Negi

Assistant Director, EY Knowledge, Ernst & Young LLP

Experienced life sciences industry analyst. Passionate about health equity. Certified Professional Coach.

Contributors