Clinical Trial Diversity in HIV

Under-representation of minority racial and ethnic groups in clinical trials has been called striking, persistent, and harmful. In the US, HIV disproportionately impacts racial and ethnic minorities, including Black and Hispanic communities, yet they participate in treatment and vaccine clinical trials at a much lower rate than whites. It’s the same story globally, where adolescent girls and women in sub-Saharan Africa, people who use drugs in Europe and Central Asia, and transgender women in Asia, the Pacific and Latin America, are also not well-represented in clinical trials. Historically, HIV clinical trial participants have been over-represented by male participants, even though women account for almost half of all new HIV diagnoses globally.

A wide range of people from different communities and backgrounds are needed in clinical trials to reduce biases, promote social justice and health equity, and produce more innovative science. Healthcare providers (HCPs) often find it challenging to apply the results of large research studies to the care of people living with HIV or who would benefit from prevention therapy, especially when the study participants do not reflect the racial identity, ethnicity, age, or sex and gender of their patients. In HIV specifically, what we learn from trial data should mirror the diverse populations we serve, including racial and ethnic minorities, men who have sex with men, transgender women, heterosexuals, women (including pregnant women), the aging population along with adolescents and children and people who use drugs.

Change is coming

ViiV Healthcare (ViiV HC), a company 100 percent dedicated to people living with HIV and those who might benefit from pre-exposure prophylaxis (PrEP), is working to increase awareness and emphasis on diversity in HIV research. To address the challenge of underrepresentation in clinical trials of new treatment and prevention options, a coordinated effort will be required across the research enterprise, including funders, researchers, regulators, scientific publications, and industry sponsors. We recognize the urgency of the issue and, for several years, have had a R&D Diversity Task Force that is focusing on the following key areas:

• Understanding demographic data for the most impacted communities. This information is critical to determining clinical trial recruitment goals. Although robust information is available for US-based populations, data is incomplete or lacking in other areas of the world where the greatest disease burden may exist.

• Using epidemiology and not census data to set clinical trials recruitment goals. Using epidemiology data for HIV domestically and globally can ensure under-represented groups (e.g., based on race/ethnicity, gender, age) are enrolled. Establishing a recruitment framework can help to achieve recruitment goals without sacrificing other research drivers.

“To address the challenge of underrepresentation in clinical trials of new treatment and prevention options, a coordinated effort will be required across the research enterprise, including funders, researchers, regulators, scientific publications, and industry sponsors.”

• Developing new clinical trial sites. Investigative sites that serve diverse populations need to be identified and may require assistance with regards to improving their research infrastructure, capabilities, and capacity.

ViiV Healthcare has achieved increased diversity in trials for a recently approved long-acting injectable pre-exposure prophylaxis (PrEP) option. In collaboration with partners at the NIH, the PrEP clinical trial program was one of the most diverse and comprehensive to date, including the enrolment of large numbers of transgender women and black men who have sex with men. Due to concerted efforts to conduct studies in adolescents in parallel with pivotal trials in adults, adolescent data was included in initial labels for recently approved ViiV HC treatment and prevention products as well. Finally, we are taking steps to study new medicines in pregnant persons at an earlier stage of development and new product registration by creating internal guidance on the inclusion of pregnant persons in clinical trials.

How else do we affect change?

As a funder and regulator, the US government can play a major role in improving clinical trial diversity. Because of legislative initiatives that incentivized or required industry sponsors to conduct pediatric clinical trials (such as The Pediatric Research and Equity Act (PREA) in 2003), over 900 pharmaceutical products now have labels which include pediatric data. Since 2001, the National Institutes of Health has issued policy and guidelines on the inclusion of women and minorities in NIH-funded clinical research to ensure that the results could be generalized to the entire population. In December 2022, the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) was signed by President Biden. FDORA includes several provisions intended to promote diversity in clinical trial enrollment, including a requirement for clinical trial sponsors to submit diversity action plans for certain late-stage drug trials, including all phase 3 trials, as well as most device studies.

Steps taken by major medical journals such as the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA) also encourage improved diversity in clinical research. NEJM now requires information about the representativeness of the clinical study group relative to the known epidemiology of the disease, problem, or condition, which creates greater understanding and transparency around the diversity of a study population. JAMA has published guidance on the reporting of race and ethnicity in medical and science journals. Consistency across clinical trials can ensure that cross-study comparisons based on race and ethnicity are more accurately reflected, and inclusive terminology can encourage diversity in clinical trials and convey respect for different demographic groups.

We have work to do

Along with efforts from other research entities, ViiV Healthcare will continue to expand our public, private, and patient partners to address diversity, equity, and inclusion issues that could help to determine other innovative ways to increase diverse participation and evaluation in clinical trials to make the goal of clinical trial diversity a reality.