By Quita Highsmith, Chief Diversity Officer, Genentech Originally published on Gene.com, June 23, 2021 and revised for republishing September 1, 2022.
Clinical trials are essential to medical progress, investigating potential new treatments and offering people with serious and life-threatening diseases novel approaches that may improve their outcomes. Data from trials help scientists and clinicians understand how investigational medicines affect different groups of people with specific genetic markers for disease and support the development of more targeted, personalized treatments. The more the make-up of clinical trials represents real-world demographics, the more robust the data, and ultimately the more effective medicines might be for patients who need them.
Right now, however, we are missing key pieces of the puzzle. Across the healthcare industry, participants in trials often do not reflect the broader population, or in some cases even the demographics of the people living with the diseases. As the United States and the world become increasingly diverse, People of Color remain vastly underrepresented in clinical research.
Currently fewer than 10% of U.S. patients participate in clinical trials, and between 5% and 15% are non-Caucasian¹. That means that the results are not always generalizable to all patient populations – often the ones most in need – and we miss out on the enormous variety of human genetic variation in our studies. Consider, for instance, that Black women have an approximately 40% greater mortality rate for breast cancer compared to Caucasian women², but represent only 6% percent of women in trials studying the disease³.
When studies do include diverse participants, on the other hand, we can make important discoveries. For example, when we enroll patients who mirror the populations living with a condition, there is a greater possibility of finding new signals that help us understand the disease and the treatment more completely and which groups of people might benefit most – or least – from a particular approach. We have an opportunity and an obligation to bring more underrepresented people into clinical research.
There are numerous examples of past success in demonstrating how to make clinical trials more diverse. Results from a research collaboration between Genentech and Stanford known as Trial Pathfinder, published in the scientific journal Nature, highlight how real-world data and AI could be used to help address underrepresentation in clinical research for non-small cell lung cancer. While recent studies show a majority of non-small cell lung cancer patients do not meet the criteria to participate in clinical trials, and 86% of trials fail to complete recruitment within the targeted time, the project was able to show that expanding restrictive eligibility criteria could increase the total number of eligible patients by 107% to include more women, African-Americans and a broader range of ages. And last year, as we saw the pandemic disproportionately and devastatingly impact People of Color, we initiated a clinical trial of one of our investigational medicines for COVID-19 pneumonia focused specifically on the recruitment of these patient groups. Approximately 85% of participants represented communities of Color, including Hispanic/Latinx, Native American and Black populations.
But beyond these and other individual examples, the question remains: How do we build a sustainable ecosystem that facilitates the inclusion of historically underrepresented people in all clinical research? In 2021 we announced our Advancing Inclusive Research® Site Alliance – a coalition of clinical research centers that are partnering with us to explore this. Together we aim to advance the participation of diverse patient populations in our oncology trials, test recruitment and retention approaches, and establish best practices that can be leveraged across the industry and other disease areas to help achieve health equity for all people.
We believe the Alliance presents an opportunity to understand and build the infrastructure we need to support inclusive research and to develop an ecosystem based on trust with committed leaders at centers who understand the communities we need to serve. We started with four inaugural partners in places that have demonstrated success in including diverse populations: Mays Cancer Center, home to UT Health San Antonio; MD Anderson, San Antonio, Texas; O’Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, Alabama; and West Cancer Center, Memphis, Tennessee.
Healthcare providers at these centers understand that if we are to achieve greater representation and more robust clinical data, we have to meet patients where they are. That means recognizing that some people who have been historically marginalized do not have access to medical benefits, physicians, or pharmacies. They might not have jobs that give them paid time off to participate in clinical trials. They may need transportation to a clinical trial site, or live in rural areas where access to sites is difficult.
We also know from a landmark study we commissioned to survey medically disenfranchised patients that many of them believe the healthcare system is “rigged against them” and that it doesn’t have the empathy it needs to treat them. In fact, the results showed that around one-in-three medically disenfranchised patients don’t participate in clinical trials, don’t get vaccinated and don’t get tested for medical conditions due to lack of trust. All of that points to the importance of medical centers that are led and staffed by People of Color, so they can engage more effectively with the community and be credible advisors to patients.
For too long the evidence of these challenges has been clear in the disparities in access, care and outcomes. And while progress has been made and I know there are many who support change, we must now step up and take bold, concrete, practical action to make a meaningful, long-term difference. Not only is it the right thing to do to eradicate these deep, systemic inequities but the more we learn from inclusive research about how disease manifests in all populations, the greater the chance we have to solve some of the most serious and complicated diseases. The Advancing Inclusive Research Site Alliance is an opportunity for us to dig deep into the lessons of how to reach these communities, build a platform of best practices and spur change across the healthcare system.