Bridging the Health Equity Gap in Clinical Development

One of the lasting legacies of the COVID-19 pandemic will be the magnifying glass it placed over health inequity across the globe. In the United States, we witnessed a disproportionate impact of the virus in minority populations, with both cases and deaths having an outsized impact in Black and Hispanic communities in particular.¹ As treatments and vaccines came to life, challenges—such as limited funding, inadequate infrastructure, and logistic issues—exacerbated existing global healthcare access inequities and highlighted significant structural issues in equitable access to healthcare innovations.² These challenges were not merely point-in-time. As of mid-2022, the World Health Organization reports that only 58 of 194 Member States reached the target of 70% population vaccination—with only 37% of global healthcare workers receiving a complete primary vaccination.³

The pandemic, along with the social and political climate in the West, accelerated many life sciences companies towards establishing global public policy positions on health equity as well as specific strategies to address the underlying systemic causes. These initiatives aim to not only reflect the global health missions of life sciences companies but attempt to address the realities of health inequity on the economics of healthcare delivery. Estimates of the total cost of health inequities in the U.S. alone top $1 trillion by 2040 (a number which takes into account increasingly unhealthy populations as well as delayed diagnoses and treatments in underserved populations), which threatens the overall affordability of healthcare and pace of innovation.⁴

For life science companies, this responsibility and subsequent opportunity often is most clearly under focus in the clinical development cycle. Collectively, the industry has recognized that inequities in treatment access often begin in clinical trials and extend throughout the product life cycle. Challenges that can arise include:

1. Clinical trials may not adequately reflect the diversity of the populations that will ultimately use the treatment, leading to a lack of data on the safety and efficacy of the treatment for these groups.
2. The disproportionate impact of diseases on certain populations and lack of both treatments and access to care for those diseases.
3. Barriers to accessing healthcare, including lack of insurance coverage or geographical distance from medical facilities. This can lead to health disparities, with some groups experiencing worse health outcomes than others.
4. Cultural and linguistic barriers can create barriers to healthcare, particularly for individuals from minority or immigrant communities. This can make it difficult for these populations to participate in clinical trials or to understand and follow treatment regimens.
5. Limited availability of treatments that may not be widely available or affordable, particularly for poorer populations. This can perpetuate health disparities and limit the impact of treatments on public health.

Life science companies are attempting to address these clinical development inequities in a variety of ways, from standing up top-down pervasive initiatives to promote diversity and inclusion in their own ranks, to relying on task forces and external partnerships to address the lessons learned from the global innovation infrastructure challenges revealed from the last three years. In clinical development, several companies (such as Bristol Myers Squibb⁵ and Merck⁶) have recognized the lack of minority clinical trial staff (at sponsors, CROs, and sites) can have an outsized impact on bringing minority populations into clinical trials. In turn, they have made significant investments to increase minority investigators in leadership roles in clinical trials, supporting the development of minority investigator careers, and engaging with minority-serving institutions such as historically black colleges and universities to identify and recruit minority investigators.

In this age of explosion in clinical data availability, real-world data (RWD) such as like claims, electronic health records, and consumer insights can also play a significant role in supporting clinical development health equity initiatives and population understanding, such as: 

1. Improving representation. RWD can be used to identify and understand the specific needs and characteristics of underserved populations, which can inform the design and recruitment of clinical trials to ensure these groups are adequately represented.
2. Providing a more complete picture of treatment effectiveness. RWD can provide a more complete picture of how treatments perform in real-world settings, which can be particularly useful for populations that may not have been well-represented in clinical trials. This can help to identify any disparities in treatment effectiveness and inform efforts to address these disparities.
3. Identifying barriers to access. RWD can be used to identify barriers to access that may prevent certain populations from participating in clinical trials or from accessing treatments once they are available. This can help to inform efforts to address these barriers and ensure that all populations have equal access to care.
4. Supporting patient-centered care. RWD can be used to support patient-centered care by providing a more comprehensive understanding of the patient experience and the specific needs and preferences of different populations. This can inform the development of treatments and interventions that are more tailored to the needs of these populations.
5. Enhancing data collection. RWD can enhance data collection efforts by providing a more diverse and representative sample of data, which can be particularly useful for studying underserved populations. This can help to improve the generalizability of study findings and inform the development of more effective treatments.

Across the landscape, it’s of critical importance that we as an industry reflect on the lessons learned over the last three years and use all our tools to engage in this moral imperative to ensure each patient (no matter their age, race, creed, location, or gender) receives the best possible care. There is much work to be done to correct the systemic social issues that underlie these health inequities, but the progress happening right now rivals any other time in our industry’s history.

References

1. “COVID-19 Cases and Deaths by Race/Ethnicity: Current Data and Changes Over Time.” KFF, 22 Aug. 2022, www.kff.org/coronavirus-covid-19/issue-brief/covid-19-cases-and-deaths-by-race-ethnicity-current-data-and-changes-over-time.
2. McGrail, Kimberlyn. “Looking Back and Moving Forward: Addressing Health Inequities After COVID-19.” The Lancet Regional Health  Americas, 1 May 2022, www.thelancet.com/journals/lanam/article/PIIS2667-193X(22)00049-7/fulltext.
3. Vaccine Equity. 20 May 2022, www.who.int/campaigns/vaccine-equity.
4. Rush, Brian Asa, et al. “US Health Care Can’t Afford Health Inequities.” Deloitte Insights, 2 Dec. 2022, www2.deloitte.com/us/en/insights/industry/health-care/economic-cost-of-health-disparities.html.
5. The Bristol Myers Squibb Foundation and National Medical Fellowships Launch $100 Million Program to Help Increase Diversity and Inclusion in Clinical Trials. news.bms.com/news/details/2020/The-Bristol-Myers-Squibb-Foundation-and-National-Medical-Fellowships-Launch-100-Million-Program-to-Help-Increase-Diversity-and-Inclusion-in-Clinical-Trials/default.aspx.
6. “We’re Training More Minority Investigators To Help Improve Diversity In Clinical Trials.” Merck.com, 9 Dec. 2021, www.merck.com/stories/were-training-more-minority-investigators-to-help-improve-diversity-in-clinical-trials