A version of this essay was first published in the book “Biotechnology in the Time of COVID-19: Commentaries from the Front Line” in June 2020.

For many of us, the coronavirus pandemic has provided more time for reflection on what is truly important. For me, as a Black woman and biotech industry leader, I’m particularly concerned about how the COVID-19 public health crisis is amplifying health disparities that have harmed communities of color for decades.

Due to a variety of wide-ranging inequities, people of color are less likely to have steady access to quality medical care. They are less likely to live in neighborhoods with healthy food options and more likely to face exposure to environmental factors that impact their health. People of color are also more likely to work in the service industry or the frontline health care field, or have lower-wage jobs that do not offer paid sick leave. During the COVID-19 pandemic, we are seeing a disproportionate number of people from historically underserved communities experience higher infection risks, with increased hospitalization and mortality rates. Preliminary data from New York City is showing that COVID-19 is killing Black and Hispanic people at twice the rate of white people, and similar trends are being reported for cities in Louisiana, Michigan, and Illinois.

A lack of access to and participation in clinical research is one systemic barrier hindering optimal health outcomes in historically underrepresented communities today. The imbalance of representation within clinical research was recognized by the federal government almost thirty years ago, with the passing of the NIH Revitalization Act of 1993. This legislation mandated that all federally funded clinical research include women and racial and ethnic minority groups. Since then, women have reached parity, with over 52 percent of participants in NIH-supported clinical research reported in 2018, but for members of racial minority groups, this number was only 29 percent, and for ethnic minorities, 9 percent.

We can no longer accept this status quo. To break this cycle of inequity and create a world where all patients can access investigational medicines, we must come together as industry leaders to take bold and decisive action.

Building The Foundation

In my previous role as head of Alliance and Advocacy Relations at Genentech, I saw firsthand how difficult it was to find diverse patients who had participated in clinical trials. I learned that this gap extends beyond diversity in patient selection into almost every aspect of clinical research—including the diseases we choose to study, where the sites are located, and the investigators themselves. This journey of questioning and exploration led me to cofound Advancing Inclusive Research™ with my colleague Nicole Richie, PhD, global head of Health Equity and Population Science at Genentech. This initiative is a priority for our company and a key strategic focus of the diversity and inclusion office.

Over the past several years, we have changed how we approach our clinical research programs in these ways:

• In our earliest communications with site investigators, we emphasize our commitment to addressing barriers to participating in clinical research.
• We modified our contract language to encourage inclusion of underrepresented patients.
• We changed our inclusion/exclusion protocols to be more inclusive of patients with diverse ethnicity (e.g. race- or sex-estimated glomerular filtration rate vs. absolute creatinine cutoff, benign neutropenia in certain ethnic groups or elevated serum creatinine in patients of African descent).

Additionally, to gain much-needed insight from experts, we formed an external council composed of physician thought leaders, academic research experts, and patient advocates. This collaboration has provided the opportunity to raise awareness with a broader audience and cocreate solutions to address inequity in clinical research.

Equally important is a continued partnership with government agencies, such as the Office of Minority Health and Health Equity at the Food and Drug Administration (FDA), with whom we share a similar vision and regularly dialog about relevant programs and initiatives.

As a result of these efforts, we are now positioned to deliver innovative new studies, such as a first-of-its-kind clinical trial to study our treatment for multiple sclerosis specifically within the Black and Latinx patient populations (CHIMES, Reference ID# ML42071).

Taking Action During A Pandemic

The emergence of COVID-19, and the disparities we see in incidence and mortality rates, has accentuated why it is so critically important to expand this work. Genentech is actively including historically underrepresented groups in its COVID-19 clinical research. In collaboration with the Biomedical Advanced Research and Development Authority (BARDA), Genentech moved quickly to set up a study to evaluate the safety and efficacy of one of our medicines in adult hospitalized patients with severe COVID-19 pneumonia (COVACTA, Reference ID# NCT04320615).

In this trial, we have intentionally included sites at the intersection of COVID-19 hot spots and underrepresented populations. For example, one of the first COVACTA patients in the United States came from Ochsner Medical Center in New Orleans, which has a large minority population with high medicaid enrollment. We had not partnered with Ochsner in infectious disease previously. Naive site selection can be incredibly challenging for companies to enroll patients under tight timelines. However, we knew we needed to prioritize locations with communities of color to take strides toward solving health inequities.

We didn’t stop there as early data suggested that the COVID-19 pandemic may be disproportionately affecting underserved and minority populations. We took this early data to hospital administrators and physicians at inner-city hospitals in New York City and our Medical Affairs organization cocreated another randomized, placebo-controlled study called EMPACTA to evaluate the efficacy and safety of one of our medicines. The study will enroll patients at hospitals across the United States that reach underserved communities, including several public hospitals in New York City. These examples show that bold investments are needed to improve the health disparities that exist. This is the deliberate type of scale that is required from the industry.

The Path Forward

Throughout my career, I’ve been inspired by the advancements we’ve achieved in science and medicine. It gives me great hope for the future. What I also know to be true is that clinical research is not benefiting all patients equally, and some communities are being left behind.

We face a great deal of uncertainty in the coming months about COVID-19 and its impact on our communities. In the interim, we cannot wait to start creating a more equitable future for all patients, which includes a steadfast commitment to increasing diversity in clinical research.

In order to create more inclusive clinical trials, we must start with the fundamentals:

• Ask clinical trial site investigators to be intentional about recruiting diverse patients.
• Expand site networks to include potentially smaller, newer sites with more diverse catchment areas.
• Prepare guidance documents with clear expectations for internal teams and external partners.

We can use this moment as a catalyst for action. Genentech’s commitment to being a change-maker has never been stronger. Each of us, whether a trial sponsor, a physician, a legislator, a caregiver, a regulator, or a patient, has a role to play.

What we have seen in response to COVID-19 is that, when the entire health care ecosystem comes together with a sense of urgency and purpose, we can overcome obstacles in ways we didn’t think possible. Not only are we seeing clinical trials designed and approved faster than ever before, but we’re seeing it can be done while including underrepresented populations. Imagine what we can achieve if we bring this same mindset and determination to solving the health disparities crisis for people of color.

Let’s be bold together.