I learned up close and personal about the necessity of improving diversity in clinical trials

As the biopharmaceutical industry places increased emphasis on improving the diversity of participants in clinical trials to create more equitable drugs, some are questioning this effort. As a biotech executive and a trial participant, I’ve seen firsthand why it’s needed.

A year ago, the industry trade association PhRMA convened more than 150 biopharma organizations for a workshop on clinical trial diversity. Since then, companies have listened to thousands of patients, health care providers, and health equity experts to understand the problem and identify solutions.

In mid-July, PhRMA launched a first-of-its-kind initiative to promote more equitable drug development. The industry is establishing a network of community-based sites for clinical trials to address key barriers to participation, and many companies, including Genentech, which I work for, are voluntarily developing and committing to industry-wide principles on trial diversity.

There’s a scientific imperative at play here. Clinical trials that include participants from underrepresented racial and ethnic groups provide researchers with more information about the experiences of all patients with a potential new medicine. That information can help highlight variable responses to the medicine between groups and further inform its safety and efficacy. Without participant diversity, scientists and researchers are trying to solve a puzzle without a complete picture of what the end product should look like.

A stark example is the study of Alzheimer’s disease. Black Americans are roughly twice as likely to develop this fatal dementia as white Americans. Yet a recent pooled analysis of two decades of clinical trials for Alzheimer’s showed that 94.7% of participants were white, while just 1.2% were Black. According to the authors of the report, modifying or changing the eligibility criteria for Alzheimer’s disease clinical trials could play an important role in enrolling more diverse participants, demonstrating that biopharmaceutical companies, clinical research organizations, physicians, and regulators must carefully consider study design and appropriate inclusion of diverse participants.

I could offer countless other examples that demonstrate why it is essential to take meaningful and thoughtful action to help ensure that underserved communities are included every step of the way in the development of new medicines. But let me give you a personal story instead.

At the end of 2020, I got a call asking me to participate in a clinical study for a potential Covid-19 vaccine. I’ve worked in the biopharma industry for years, and currently serve as Genentech’s chief diversity officer. I was curious to see what the real patient experience was like for those enrolled in clinical trials, so I agreed to participate.

Red flags popped up immediately. On the initial informational video call for potential participants — a call specific to people of color — the investigator was condescending and inconsiderate. When one participant asked if it was OK to ask a question, the investigator snapped and said we could not speak, only put questions in the chat. There were only 15 people in total on the call.

I would not have continued after that call, but because I am in the industry and truly want to understand the process so we can find solutions, I continued.

The day finally arrived when I was supposed to go to the trial site to get the first injection. But before leaving my house, the coordinator I’d been working with called me and told me that “‘the sponsor has deprioritized Blacks and you are no longer needed.”

Based on my experience and my current role, I know the gaps that exist in enrollment in clinical trials. I also know that Black Americans are more than twice as likely to be hospitalized due to Covid-19 than non-Hispanic white people. So I knew what the coordinator was saying simply wasn’t true. They needed more people that look like me in this study, not fewer, because Black people need to gain better access to potential vaccines for a disease that continues to kill them at higher rates.

As an executive in the industry, I have access to many company’s leaders. So I called the CEO of the company sponsoring the study. He was shocked and appalled with the information I’d been given by the coordinator. He told me they absolutely needed more participation by people from communities of color.

The next day, the primary investigator called me and personally apologized for the actions of the trial site coordinator. She shared that this person had not understood the broader implications of the study and the need for enrollment of Black Americans. Sure, that’s probably true. But it means that around the country, people like this coordinator are likely turning away Black people from other clinical studies even as trial sites struggle to recruit diverse participants.

It also means that this particular site lost my trust.

This story plays into the medical mistrust that abounds in communities of color. In fact, Genentech conducted a second health equity study last year that revealed that more than half of medically disenfranchised patients continue to feel the system is rigged against them, and they overwhelmingly agree that health care inequities have worsened over the course of the pandemic. Information like this, along with records of past wrongs, oral histories shared by families and communities, and everyday experiences like mine demonstrate that mistrust and health inequity continue to be a crisis.

The biopharma industry’s efforts to improve the diversity of clinical trials are grounded in working toward building trust with people of color and other underrepresented communities around the country. We are acknowledging and lifting up how experiences with medical bias, mistrust of the health care industry, and historical mistreatment of people — most famously the U.S. Public Health Service Syphilis Study at Tuskegee — are leading to major changes in how clinical trials are conducted to protect the rights, safety, and welfare of participants. Now we need to address systemic barriers like the one I experienced that keep underserved communities from participating in clinical trials.

In addition to enrollment issues, the industry is focusing on improving the public’s understanding of clinical studies and making sure community-based sites have sustainable support. Other barriers that need to be addressed include the limited number of investigators from diverse backgrounds, and the financial and time burdens that participating in trials can place on participants.

Diversity in clinical trials is also an issue of fairness. Right now, people from communities of color and rural communities may not have easy access to clinical trial sites, effectively depriving them of the choice to participate. That’s not right.

Equally important is that clinical and genetic data enriched by more representative clinical trial participants will help evolve the promise of personalized health care to achieve more accurate diagnoses and optimize treatment outcomes for all.

Improving the diversity of clinical trial participants is about more than acknowledging historical mistreatments. It’s about fixing in real time the systemic barriers that people of color often deal with today when attempting to participate in this type of research.

Quita Highsmith is the chief diversity officer at Genentech.