Inclusive at the Start, from the Top
Improving Inclusive Thinking and Patient Engagement to Boost Clinical Trial Diversity
Clare Grace
Annette Jack
Maimah Karmo
Tigerlily Foundation
Shanda Cooper
Tigerlily Foundation
Lizzie Wittig
Tigerlily Foundation

arely does a one-size-fits-all approach succeed in business, education, or politics, and it should be no different for the delivery of quality healthcare. To ensure everyone has access to safe, effective medications and treatments targeted to each respective population’s needs—regardless of race, ethnicity, gender, age, or socioeconomic status—the treatments we develop must be researched, studied, and evaluated, with representation from diverse populations.

This is critical because ethnicity, gender, age, and disease severity all significantly influence how individuals respond to medications. When studies are conducted and evaluated only in older white males, for example, we cannot extrapolate the impact from these data on Hispanic women, African American men, adolescents, or Asian populations.

The consequences are real: One study revealed that approximately 20 percent of drugs approved within the previous six years had different exposure and/or response among racial and ethnic groups. Yet, despite a renewed push for diversity, most clinical trials conducted today still fail to represent the demographic diversity of populations that drugs aim to serve.

Overcoming Persistent Barriers

According to the FDA, African Americans made up 13 percent of the US population in 2019, but only 9 percent of trial participants were African Americans. To address the racial and ethnic underrepresentation in clinical trials, we must first understand the root causes of barriers to inclusion.

  • Systemic and Structural Racism in Healthcare. Reports from as early as the 1800s acknowledged that tests were conducted on the Black population to support strenuous labor practices during and after slavery. Just last year, there were reports of forced hysterectomies among immigrant women detained at a Georgia Immigration and Customs Enforcement (ICE) facility, and Black and Latinx patients tend to experience longer emergency room wait times for stroke medications. These and other abuses have instilled a lack of trust in the medical establishment and the pharmaceutical industry among these communities.
  • Socioeconomic constraints. Due to socioeconomic and systemic barriers brought about by historical racism, redlining, white privilege, and exclusionary practices, people of color can experience disparities in income, employment, and access that may preclude them from participating in clinical trials. Among many examples: 64 percent of Black parents are single versus 24 percent of non-Hispanic white parents.
  • Communication barriers. Clinical trial recruitment materials are often provided in English only, without regard for varying levels of health literacy or for diverse cultural values and preferences, possibly inhibiting participation.
  • Cultural barriers. Cultural nuances about the stigma of disease pose barriers to trial participation, yet materials are created without input and cultural insights from affected populations.
  • Lack of provider diversity. Clinical trial participants may feel less comfortable receiving care from those who do not share their cultural or ethnic background.

Overcoming these barriers should begin with the very first conversation about research priorities and drug development programs. Industry and partners must focus equally on relationships and research by bringing in, not just partnering with, underserved groups representing diverse populations.

Numerous groups are making important strides in this area. The Tigerlily Foundation, who educate and support young women with breast cancer, hosts a monthly series of bi-directional conversations between female Black patient experts and non-BIPOC (Black, Indigenous, and People of Color) healthcare professionals. The UK’s National Institute for Health Research established a Race Equality Public Action Group to give people from disparate communities a stronger voice in shaping research and volunteer recruitment for clinical trials.

To boost recruitment, we must work with trusted community leaders to disseminate information and advocate for the importance of clinical trial participation. The COVID-19 pandemic has highlighted how we have collectively elevated awareness of clinical trials and their role in advancing new vaccines. For example, the Caribbean and African Health Network held an online vaccines event attracting 1,000 people on Zoom.

To reach diverse audiences, we should establish mandatory clinical trial language requirements to account for varying degrees of health literacy, language barriers, cultural sensitivities, and inclusiveness for LGBTQ and non-binary individuals.

The New Face of Clinical Trials

The time for action is now, and practical tools exist for researchers looking to improve trial diversity. The INCLUDE Ethnicity Framework, as an example, helps trial teams identify and include racial and ethnic groups.

We must also reduce the patient burden by bringing trials to patients rather than patients to trials. Regulatory progress is being made, with FDA issuing a written guidance in November 2020 urging researchers to include study locations in geographic areas with high numbers of underrepresented racial and ethnic populations. The shift to decentralized trials must continue and expand where feasible, and we should recruit diverse healthcare providers who mirror the study participants we seek to attract.

By improving patient engagement in clinical research from the start and partnering with underrepresented communities, we can expand the pool of trial participants and address disparities in access to care, ultimately speeding the development of safe and effective medicines for all. This goal is our shared ethical, societal, scientific, medical, and business imperative.