Abstract
Achieving personalized healthcare for all people, including the most vulnerable Hispanic communities, may appear to be an insurmountable task or an impossible reality. Biotech pioneer and thought leader Genentech, a member of the Roche Group, has taken deliberate and strategic steps toward reaching this goal. Strategic priorities for this effort include developing policies focused on inclusive practices, increasing the amount of genomic data and scientific insights from underrepresented populations, and leveraging partner relationships to develop actionable strategies to increase clinical research participation. Through collaboration with the broader healthcare ecosystem, progress can be made to help remove systemic barriers for communities of color and build a future of precision medicine.
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Keywords
Better Science and Better Medicine
To deliver the personalized medicine of tomorrow and advance better health outcomes for all, today’s clinical research must reflect current demographic trends and include more underrepresented populations, including members of the Hispanic community. Currently, Hispanics are the youngest and largest minority group in the United States [1], yet they represent only 1–8% of patients enrolled in US clinical trials [2]. The lack of participation in clinical trial research, coupled with systemic factors such as higher unemployment rates [3] and higher likelihood to be uninsured [4], means that many Hispanic communities are being left behind and do not have equal opportunities to access investigational medicines and contribute to medical-scientific progress.
Throughout the COVID-19 pandemic, communities of color have experienced disproportionately negative outcomes compared to Whites. Data from the Centers for Disease Control and Prevention show that Hispanic and Black people are nearly three times as likely to become hospitalized by COVID-19 and are nearly twice as likely to die from the virus as non-Hispanic Whites [5]. Without significant participation in clinical research from underrepresented groups, it will be much more difficult to develop novel treatments and therapies that will be effective for all racial and ethnic backgrounds.
Improving health outcomes for our most vulnerable communities must be a coordinated effort among the healthcare industry, clinical researchers, academia, advocacy organizations, and policymakers. To make meaningful progress, the entire healthcare ecosystem needs to work together to reduce disparities in clinical research participation for underrepresented groups, improve patient access to clinical research, elevate patient-centric development, and enrich the quality of clinical information available in the development of personalized healthcare.
Advancing Inclusive Research
Genentech is deeply committed to addressing health disparities and believes all patients should have access to the best care and treatment available. As a founder of the biotech industry, Genentech envisions a world where all individuals can experience the full potential for their health and well-being while enabling a future of science that is more diverse, inclusive, and equitable.
To deliver on this vision, Genentech developed Advancing Inclusive Research, a US-focused and cross-organizational initiative to ensure clinical trial participants are representative of broader patient populations so that everyone with serious and life-threatening diseases has the opportunity to benefit from investigational medicines and enrich understanding of clinical and genomic data to inform science and personalized healthcare. As a Latina who is passionate about addressing cancer disparities impacting my community, my family, and future generations of Latinos, Advancing Inclusive Research is more to me than just an initiative. It is a moral obligation and a scientific imperative.
Insights into Action
Advancing Inclusive Research is grounded by three strategic pillars. First and foremost, Genentech’s clinical development strategy is to expand inclusion of diverse patient populations. Second, we aim to generate insights from meaningful data. Third, we are committed to working with others and positioning Genentech and Roche as a trusted external partner.
Clinical Trial Strategy and Operations
Over the last 2Â years, Genentech has reevaluated its clinical development strategy to determine how we could enable more clinical research participation. We began by selecting specific disease areas to pilot research based on needs in the respective therapeutic areas, the presence of known disparities, and where we believed we could have the greatest impact. While still in the early phases of these learnings, best practices will be applied to additional therapeutic areas.
Our clinical development strategy has also led to internal structural changes across the company, including a Chief Diversity Office and a health equity population and science team to elevate awareness across all internal clinical study teams in early- and late-stage development. We are educating clinical study teams on inclusive research principles, with the goal of reflecting real-world populations in Genentech’s clinical trial enrollment.
Additionally, we are expanding our site networks to include some smaller, newer sites with more diverse catchment areas. As part of this process, we are asking clinical trial site investigators and research staff to be deliberate about recruiting diverse patients and to help us identify barriers to participation so that we can support needed services such as transportation and child care during clinical trial appointments. We are currently working to implement a technology in all possible trials that would enable real-time and automated payments to patients in order to cover their out-of-pocket expenses.
Through these collective efforts, we are now poised to deliver clinical trials across our pipeline portfolio that imbed inclusive research principles, as well as innovative new studies that address health disparities specifically in communities of color.
Scientific Insights and Personalized Healthcare
The concept of personalized healthcare is evolving into more individualized care. Today’s model of care delivery is still grounded in the idea of evaluating one patient segment, identifying one biomarker, and developing one treatment or therapy. The paradigm of the future will be built around a single patient and creating a comprehensive profile of that person to deliver truly individualized care. Two key components that we plan to implement are leveraging key partnerships and identifying strategies to address the lack of diversity in genomic material available to scientific researchers.
To bring us closer to this reality, we aim to leverage Roche’s unique partnerships with Foundation Medicine (FMI) and Flatiron to provide data insights that can help us answer scientific questions, aid with trial recruitment, and engage diverse communities to improve access to diagnostics and treatment.
Through genomic research, we can begin to identify those molecular drivers that can predict disease susceptibility, efficacy, or safety differences in response to treatments in specific patient populations. For example, a 2014 genomic study of Latina women led to the discovery of a novel variant with protective effects that lowers the risk of breast cancer (for those with more Indigenous American ancestry) [6].
We realize that the benefits of genomic testing and genomic research will require education and building trust with communities of color. We aim to continue to identify trusted partners within the community to engage patients on these complex topics.
External Partnerships
To move the inclusive research discussion from theory to an actionable path forward, Genentech formed an interdisciplinary council focused solely on addressing disparities in clinical research. Founded in 2018, Genentech’s External Council on Advancing Inclusive Research has been instrumental in helping to develop strategies to address disparities in research. The group is composed of physician thought leaders, academic researchers, specialty CRO executives, and patient advocates with expertise in oncology, ophthalmology, and neuroscience clinical care, research, and genomics. As subject matter experts who are uniquely positioned to affect strategy, execution, and healthcare policies, they bring valuable insight from their collaborations with patient organizations, data-driven firms, research centers, regulators, and other stakeholders.
Key outcomes informed by Genentech’s External Council on Advancing Inclusive Research include the following:
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Development of an internal guidance document for study teams
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Revision of contract language to encourage inclusion of underrepresented patients
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Update of inclusion/exclusion criteria to be more inclusive of patients with diverse ethnicity
These efforts have been instrumental in implementing changes across our clinical development teams.
Patient and Advocacy Communities
Patient engagement has and continues to be a critical factor in the success of Advancing Inclusive Research. Genentech has a long history of partnering with patients and advocacy groups across oncology, ophthalmology, neurology, and PHC, in the United States and globally. Genentech’s work with patient advocacy groups helps to build trust in the healthcare ecosystem, and it deepens the company’s understanding of a patient’s journey.
Policymakers and Regulatory Agencies
Advancing Inclusive Research also relies on collaboration with policymakers and regulatory agencies. Genentech is an active participant in key discussions around policies that address obstacles that have previously prevented communities of color from participating in clinical research, such as out-of-pocket costs.
Conclusion
Our goal at Genentech is for all people to achieve a future of personalized healthcare. In order to deliver on the promise of precision medicine, we must provide the right treatment, to the right patient, at the right time.
Reflecting on the emergence of COVID-19, we see the entire industry working together to quickly innovate and develop the best possible treatments. We know that measurable progress is possible. Now imagine what is possible, if we, the trailblazers of biotech, patient advocacy, and medicine, bring that same mindset and urgency to addressing the systemic barriers that prevent Hispanic patients from clinical research participation. Imagine a world where the most vulnerable receive optimal care and enjoy better health outcomes. It is good for them. It is good for us. It is good for society at large.
Much has been accomplished over the years, and yet there is much more to do for our communities of color. To fully realize our vision—personalized healthcare for everyone—we must innovate frequently, collaborate often, and challenge outdated ideas until all people, including Latinos, help to make the promise of precision medicine a reality.
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Gonzales, M. (2023). Overcoming Clinical Research Disparities by Advancing Inclusive Research. In: Ramirez, A.G., Trapido, E.J. (eds) Advancing the Science of Cancer in Latinos. Springer, Cham. https://doi.org/10.1007/978-3-031-14436-3_16
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