The World Health Organization defines health equity as “the absence of unfair, avoidable or remediable differences among groups of people, whether those groups are defined socially, economically, demographically, or geographically or by other dimensions of inequality (eg, sex, gender, ethnicity, disability, or sexual orientation). Health is a fundamental human right.

Health equity is achieved when everyone can attain their full potential for health and well-being.¹

To address disparities in health equity, it is important to address the challenges different population groups and communities face in accessing healthcare;² to do this, we must first distinguish between inequality and inequity, which are often confused and used interchangeably.

Inequality generally refers to “any measurable aspect of health that varies across individuals or according to socially relevant groupings… Absent from the definition of health inequality is any moral judgment on whether observed differences are fair or just.”³

A health inequity is “a specific type of health inequality that denotes an unjust difference in health.”³ Traditionally, matters of health inequality and inequity were viewed as being the responsibility of government organizations. However, the pharmaceutical industry can play a strategic role—for example, in research, education, and shaping policy.

Exploring the challenges researchers face in diversity and equity in clinical trials and the pivotal role manufacturers can play to help address this imbalance.

Clinical trials are a vital step in the development of new technologies, and clinical trial participants should represent the patients that will ultimately benefit from the medical intervention. Unfortunately, this is not always the case, creating challenges with the generalizability of the data to the wider population.

Numerous studies have shown the disparity between clinical trial representation and the general population. A study published by the American Society of Clinical Oncology “observed a decline in the recruitment of African Americans, Hispanics, and women over a period of 14 years compared with historical data. African Americans, Hispanics, and women were less likely to be enrolled in cancer clinical trials.” The study concluded that future trials should take into consideration measures to recruit participants that truly represent the US cancer population.⁴

It is important first to understand that scale of the problem and then take steps to address it. In 2020, a Snapshots Summary Report published by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research showed that participants in clinical trials of new molecular entities and therapeutic biologics approved in 2020 were 75% white, 8% black or African American, 6% Asian,11% Hispanic, and 30% were 65 years of age or older.⁵

So why are certain groups so often underrepresented in clinical trials?

Racial and ethnic minority groups, women, the elderly and disabled people⁶ still remain underrepresented in clinical trials; factors that contribute to this lack of diversity, equity and inclusion include trust, education, unconscious bias, and access to services.⁷

Manufacturers can help address inequity in clinical trials by working with community and patient groups to build trust and expand participation, ensuring they provide tailored training material for research teams (which resonate with specific patient groups), and ensuring that educational materials and consent forms are suitable for lay readers.

Commitment to diversity is also promoted by agencies such as the FDA; in 2020, it published updated guidance, “Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs,” which recommends approaches that sponsors of clinical trials can adopt to increase enrollment of underrepresented groups.⁸

As we move towards personalized medicine, it is even more important that we are more inclusive in our clinical trial design and that our trials are more generalizable to the population we want to treat.

Health equity is not limited to clinical trials; it touches on a wide variety of areas that cross-functional teams within biopharmaceutical companies can work together to address. This is part of a series of articles covering broader health equity themes.

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References

1. Health Equity. World Health Organization. https://www.who.int/health-topics/health-equity#tab=tab_1 [accessed March 6, 2024].
2. Health equity and the UK Health Security Agency. https://ukhsa.blog.gov.uk/2022/10/19/health-equity-and-the-uk-health-security-agency/ [accessed March 4, 2024].
3. Arcaya MC, Arcaya AL, Subramanian SV. Inequalities in health: definitions, concepts, and theories. Glob Health Action. 2015;8:27106.
4. Duma N, Vera Aguilera J, Paludo J, Haddox CL, Gonzalez Velez M, Wang Y, Leventakos K, Hubbard JM, Mansfield AS, Go RS, Adjei AA. Representation of Minorities and Women in Oncology Clinical Trials: Review of the Past 14 Years. J Oncol Pract. 2018:e1-e10.
5. FDA 2020 Drug Trial Snapshot Summary Report: https://www.fda.gov/media/145718/download [accessed March 6, 2024].
6. Make Sure People with Disabilities Are Included in Clinical Trials: Your Participation Is Needed! https://acl.gov/news-and-events/acl-blog/make-sure-people-disabilities-are-included-clinical-trials-your#:~:text=One%20in%20four%20people%20have,disabilities%20(I%2FDD) [accessed March 6, 2024].
7. Embracing Diversity: The Imperative for Inclusive Clinical Trials. https://postgraduateeducation.hms.harvard.edu/trends-medicine/embracing-diversity-imperative-inclusive-clinical-trials#:~:text=Lack%20of%20Access%20to%20Healthcare,of%20inclusivity%20in%20clinical%20trials [accessed March 4, 2024].
8. Enrollment Practices, and Trial Designs Guidance for Industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial [accessed March 5, 2024].