In December 2024, we had the honour of speaking with Esther Marfo of Roche Canada about the Advancing Inclusive Research® Site Alliance initiative, which will receive PSG’s prestigious Leadership and Innovation Award in 2024. Since 2022, it has been presented to individuals making significant contributions to the Canadian pharmaceutical industry.
The Advancing Inclusive Research® Site Alliance is an innovative collaboration of clinical research sites working with Roche Canada to improve the representation of diverse patient populations in clinical trials. This initiative tests new recruitment and retention strategies for minority populations while developing best practices to promote health equity across the industry.
To celebrate their achievements, we spoke with Esther and Roche Canada about the Advancing Inclusive Research® Site Alliance’s work towards providing equitable data to underserved populations, fighting stigma and educating these populations on the benefits of health literacy. Here’s what they had to share:
What inspired Roche Canada, to prioritize diversity and inclusion in clinical research through the advancing inclusive Research Site Alliance? And was there a specific event or realization that sparked this initiative?
Esther Marfo: I’d like to begin with a quote we often reference in the Site Alliance team. Margaret Mead once said, “Never doubt that a small group of thoughtful, committed citizens can change the world.” This resonates deeply because this effort started with just such a group.
Data-driven insights revealed a significant and well-documented disparity in clinical research. While clinical trials offer additional treatment options for patients, underserved and understudied populations are often left behind.
The data shows that 91% of genomic information comes from individuals of European ancestry, leaving a substantial portion of the population without equitable access to the benefits of cutting-edge medical advancements.
At Roche Canada, we approach this issue with a multi-faceted strategy, but we know it’s not something we can solve alone. That’s why we’ve partnered with health professionals and patient groups—those closest to the communities impacted.
The Site Alliance was born from a shared vision: to collaborate with institutions committed to addressing this disparity. Our goal is to co-create solutions that foster diversity in clinical trials and ensure that all populations can benefit from advancements in science and medicine.
With only one to 3% of eligible Canadians participating in clinical trials, what strategies is Roche Canada employing to increase awareness accessibility, especially in comparison to countries like the UK, with higher participation rates?
E.M: Our approach is multi-faceted, rooted in a deep dive into research to identify barriers to trial participation. Two key challenges emerged: health literacy and privacy concerns. For many minority groups, stigma surrounding clinical research persists, often tied to historical injustices that have eroded trust.
Through our partnership, we’re focused on education—laying a foundation to help healthcare professionals and patients understand the benefits of clinical trials. Accessibility is also a priority as we work to ensure trials are approachable and inclusive for all patients.
We’ve created educational videos to address these needs to inform patients and healthcare professionals about clinical trials. Additionally, we’ve collaborated with healthcare professionals in Alberta to develop supplemental training materials for current and future physicians. These resources are designed to build knowledge, foster trust, and ultimately support greater diversity in clinical research participation.
The University of Alberta became the first Canadian member of the Site Alliance. Are there any additional sites in Canada, and how does Roche Canada envision expanding this network?
E.M: Currently, the University of Alberta is our sole partner site for this initiative, but we’re open to expanding the alliance to include additional sites. That said, we recognize this is just one step toward driving meaningful change in Canada.
We’re committed to building a broader strategy that identifies opportunities to collaborate with more institutions nationwide, fostering a network where we can learn from one another. By working together to break down barriers, we aim to support all clinical trials and ultimately transform the clinical research landscape across Canada.
What role does the University of Alberta’s geographic and ethnic diversity play in advancing the initiative goals?
E.M: Alberta, Canada’s fourth most populous province, is known for its diversity—27.8% of its population identifies as visible minorities, and 6.8% identify as Indigenous. Additionally, Alberta has seen an influx of new immigrants, enriching its cultural fabric. The University of Alberta stands as a hub for innovation and cutting-edge treatments, making it a pivotal partner in our efforts.
However, Alberta also presents unique geographical challenges. With 15% of its population living in rural areas, the typical placement of research sites can limit accessibility. Addressing these barriers is a priority, and Alberta’s size and diversity make it an ideal province to study and develop solutions that can inform broader strategies across Canada.
How is Roche Canada using the data collected through the alliance to create actionable benchmarks for diversity and inclusion in clinical trials? Could you elaborate on how this data informs future strategies?
E.M: We’ve made significant progress by developing tools like dashboards to benchmark and monitor our advancements. The insights gained from the Site Alliance and these tools enable us to identify underserved patient groups more effectively.
Understanding where our patients are located helps us incorporate decentralized elements into protocol design early in the trial process. This data-driven approach allows us to refine our strategies—identifying what works best and pivoting where needed. For instance, data sources can pinpoint patient locations, enabling us to reach these groups more directly and ensure they can access clinical trials.
Reaching Indigenous and rural populations is a significant challenge in diversifying clinical trials. How does Roche Canada plan to overcome these barriers to ensure inclusivity? Can you share specific examples of its impact so far?
E.M: We prioritize implementing decentralized clinical trial (DCT) elements to enhance accessibility and patient convenience. For example, the e-consent process allows patients to agree to participate in trials using telehealth technology from the comfort of their homes.
Mobile nursing is another key focus, enabling home visits as part of the protocol design. Where feasible, mobile nurses are integrated into the trial process to meet patients where they are.
For those who prefer not to have home visits, whether by a mobile nurse or study coordinator, we ensure provisions are in place to reimburse transportation costs and, in some cases, provide accommodations. These arrangements are handled on a case-by-case basis to support patient participation.
What additional challenges does Roche Canada foresee in building a robust system that ensures greater inclusivity and representation of diverse populations in clinical trials? Can you share specific recruitment, infrastructure, or policy hurdles with us?
E.M: Accurate data collection is a critical focus area for us. Robust data sources are essential to ensure the information’s reliability. For instance, capturing race and ethnicity is a self-reported process guided by health authority regulations. However, the categorization of race and ethnicity is limited, primarily reflecting the FDA’s definitions, which are used globally.
This limited framework can make it challenging to capture the diverse identities of our patients accurately. Additionally, self-reported data can sometimes lead to inaccuracies, as patients may unintentionally misidentify themselves. While we do not influence these responses, this data is vital for tracking the progress of our enrollment goals.
These limitations highlight the challenges of ensuring our strategies are effective and meeting our diversity goals in clinical trials. Addressing these issues remains a priority as we strive to refine our processes and improve the inclusivity of our research efforts.
There’s very much nuance in capturing those populations.
E.M: Absolutely. We are actively working to expand the categorization process, offering patients more inclusive options to identify themselves accurately. This effort goes hand-in-hand with addressing the stigma often associated with clinical trials. We aim to build trust with underserved patient groups through ongoing education initiatives, though we recognize this can be a significant challenge.
We’re also focused on enhancing the adoption of decentralized clinical trial (DCT) elements, ensuring they are tailored to meet site personnel’s and patients’ needs. Making these processes more fit for purpose is a priority and an area we continue exploring and refining.
Looking ahead, what are Roche’s key objectives for the Advancing Inclusive Research Site Alliance? Are there specific milestones or expansions planned to further its mission?
E.M: We understand that site partnerships are just one component of our strategy for success. While continually exploring opportunities to partner with more sites, we focus on expanding the alliance into Ontario as part of our Canadian efforts.
However, it’s essential that we identify the right partners who align with our criteria and vision. To support this growth, we’ve developed educational videos to shift mindsets, build trust, and drive progress.
Looking ahead, a key milestone is creating more patient stories. These narratives are critical for fostering trust and confidence in clinical trials, further strengthening our commitment to inclusive and impactful research.
Mark your calendars for February 25, 2025, and join us at the PSG Gala & Awards Ceremony as we celebrate Roche Canada and our other exceptional award recipients!
