BIO – Why we Must Improve Clinical Trial Diversity – and How

By J.P Carroll – View Original Publication

Black Americans have lost 3.25 years of life expectancy and Hispanic Americans have lost 3.88 years as a result of the COVID-19 pandemic, according to new research published by the British Medical Journal.

This is just the latest among the longstanding health inequities brought to light by the pandemic, which has disproportionately affected historically underserved and underrepresented communities.

“We must do better. It is time to do more. It is unacceptable for some people to suffer more than others. It’s unacceptable for them to lack access to life-saving cures and treatments,” BIO President and CEO Dr. Michelle McMurry-Heath said in her opening remarks for BIO’s first-ever Clinical Trial Diversity Summit, which took place virtually June 24-25, 2021.

“It’s unacceptable for them to be left out of trials that ensure drugs and treatments meet their needs today and in the future,” she added.

Addressing insufficient diversity in clinical trials now will ensure health inequities are not exacerbated in the future—for COVID-19, and other diseases. When therapies, vaccines, and medicines in the clinical pipeline are developed while including all patients they will serve, it ensures that all sectors of the larger population benefit.

The causes of lack of diversity

Optimal patient outcomes are more likely with clinical trial diversity. At this time, clinical trials for new therapies, vaccines, and medicines do not sufficiently reflect the diversity of patients including those from underserved communities which have long suffered from health inequities. At BIO’s Clinical Trial Diversity Summit the clear consensus was that clinical trials structured with diversity as a key priority will produce the best possible patient outcomes.

One area of concern raised was that major pharmaceutical companies are continually approaching large institutions for clinical trials, yet these institutions are not spending enough time with historically underserved and underrepresented communities to convince them to join trials, according to Dr. Elena V. Rios, President & CEO of the National Hispanic Medical Association and President of the National Hispanic Health Foundation, speaking during the summit.

“Pharma companies are going to the same places for the clinical trials,” she said, which are “large institutions” where doctors “aren’t necessarily interested in spending the time to educate our community to get involved in the trials.” Instead, they are “picking and choosing what patient they think might be more compliant and easier to work with and we know we have doctors who can convince our patients to get involved if they have the support to develop the research.”

Understanding and addressing mistrust

Another root cause for the lack of historically underserved and underrepresented communities in clinical trial is the mistrust from these communities in joining such endeavors, as well. As Dr. Ted Love, President and CEO of Global Blood Therapeutics (GBT) and Chair of the Emerging Companies Section of the BIO Board of Directors put it during the Summit, a way of addressing mistrust is by meeting with advocacy groups, which was essential to “getting input and building trust” ahead of trials for GBT’s sickle cell disease (SCD) treatments.

For the Black community, one major cause of this mistrust is the Tuskegee syphilis study, from 1932-1972. The Black male participants did not give informed consent, and all those who had syphilis were not given available treatments.

Similarly, for the Hispanic and Latinx communities, mistrust could stem from events like the sterilization of Mexican-American men and women in California due to a 1909 sterilization law that disproportionately impacted Mexican-Americans, or the deaths of Puerto Rican women who did not know they were participants in the 1955 Enovid birth control clinical trials. Native American communities endured similar hardships as evidenced by the U.S. government admitting in 1976 to the unauthorized sterilization of Native American women. According to a study by the U.S. General Accounting Office, 3,406 Native American women were sterilized without their permission between 1973 and 1976.

Asian American Pacific Islander (AAPI) communities are also underrepresented in clinical trials. For AAPI communities, the mistrust stems in part from facing their own history of being subjected to medical racism, such as when the Territory of Hawai‘i’s Board of Health approved of a controlled fire to burn buildings in Honolulu’s Chinatown when the Bubonic plague reached it in 1899. The fire almost exclusively injured and displaced AAPI community members. Ultimately, this can lead to research development outcomes—new treatments—not meeting the needs of all patients.

How do we improve clinical trial diversity?

Over the two days of BIO’s Clinical Trial Diversity Summit, speakers from patient advocacy organizations, academia, and biotechs large and small discussed the importance of making diversity a priority in how we think about planning and implementing trials, as well as practical modifications that could encourage members of minority communities to participate.

With COVID-19 disproportionately impacting underserved and underrepresented communities, companies prioritized trial diversity to ensure the success of their COVID vaccines and therapeutics. Moderna slowed down enrollment in the phase 3 trial of their vaccine to ensure greater representation of members of minority communities most at risk of contracting COVID-19. As another example, Pfizer increased its trial size to be more inclusive, including participants as young as 16 and individuals with Hepatitis B, Hepatitis C, and chronic, stable HIV. In fact, enrollment of minority participants in both the Moderna and Pfizer trials came close to the share of the U.S. population.

But there’s much more work to do.

It’s important historically underserved and underrepresented communities are directly involved in the process of “co-creating” trials, said Dr. Randall C. Morgan, Jr., President and CEO of the W. Montague Cobb/NMA Health Institute.

Practically speaking, improving trial diversity comes down to being flexible to the realities of trial participants, said Dr. Love. His suggestions include facilitating transportation and providing flexible evening and weekend scheduling for participants who cannot take time off work. It’s also important to be mindful of site selection, so as to ensure greater participation of minority communities in COVID-19 vaccine trials, said Dr. Melanie Ivarsson, Senior VP of Clinical Development at Moderna.

Improving diversity in clinical trials must be a focus before they start and after they end, added Dr. Love. In addition, that trial staff should be properly educated—and diverse themselves. It’s important to conduct implicit bias training, noted Moderna’s Dr. Ivarsson. Research staff, partners, and vendors should also reflect the diversity of patients and communities served by research developments, said Dr. Asha S. Collins, U.S. Clinical Operations Head for Genentech.

Is there a role for government? While Tamar Thompson, VP of U.S. Government Affairs and Policy for Alexion Pharmaceuticals, believes there is a role for regulators in ensuring biotechnology has more diverse trials, corporate activism is just as essential. There must be a concerted effort across the industry for firms to hold one another accountable, added Dr. Darryl Sleep, Chief Medical Officer at Amgen.

One final note: commit to communicating results to patients and staying in touch in the long term, added Dr. Love. Patients want to know trial results.

The big picture

The BIO Clinical Trial Diversity Summit is part of BIO’s BIOEquality Agenda, a national effort in collaboration with BIO partners and member organizations to counteract systemic inequality, injustice, and unfair treatment of underserved communities.

At the heart of this effort are three pillars of change:

• Promote Health Equity, including enhancing clinical trial diversity through partnerships with Contract Research Organizations and Minority-Serving Institutions.
• Invest in the Current and Next Generation of Scientists, by establishing STEM training best practices for underrepresented populations and facilitating a partnering network, including the hiring of industry-trained minority scientists and engineers.
• Expand Opportunity for Women and Other Underrepresented Populations,  including enhancing use of minority- and women-owned small businesses in biotech supply chains, to promote economic development of marginalized communities.