Driving better health outcomes: Joining hands to improve Diversity & Inclusion efforts in clinical trials

Diversity and Inclusion (D&I) are top of mind for everyone these days. As a professional in the healthcare ecosystem, it’s been promising to see this surfacing as a high priority within the clinical research community in the past two years. The global COVID-19 pandemic and the continued response to social injustice have activated people from all parts of the world to respond with heart and humanity and seek steps to drive change.

When I think of diversity, I consider three different aspects: geographical regions, socioeconomic groups, and ethnic and racial backgrounds. The lack of diversity in clinical trials remains a key barrier in achieving equitable health outcomes for all. To drive purposeful change in biopharmaceutical R&D, it’s not enough to create solutions aimed at streamlining operations and adopting new technologies—solutions must be acceptable to, and supported by, the intended users.

In clinical research I often see brilliant, innovative technologies proposed to modernize the way we conduct research and development. However, when you consider the socioeconomic diversity of the patient population, and how the digital divide may come into play, it’s crucial for the technology innovators to be thoughtful in how to enable and provide their solutions to diverse groups of patients. If we don’t consider health equity, we will continue to create gaps and challenges in D&I.

Barriers related to diversity and inclusion in clinical research are multifaceted: language barriers, socioeconomic gaps impacting recruitment and enrollment, and a fundamental lack of trust towards medical research rooted in historical events. As a child of non-English speaking parents, I observed close family members navigate the hurdles of not fully understanding medical treatment options offered due to language barriers. The lack of trust from diverse patient groups towards medical research cannot be overlooked and should be addressed thoughtfully and thoroughly.

All stakeholders must work together and collaborate. We are all on the same team, and we all have an obligation and a role to play, individually and collectively, to move in the right direction.

TransCelerate recently launched its Diversity of Participants in Clinical Trials Initiative, which seeks to move beyond prior awareness-building activities and equip sponsors and ecosystem stakeholders with actionable tools and resources to improve outcomes through diversification of participants in clinical trials.

I recently spoke with TransCelerate Board of Directors Member Dietmar Berger, who is the Global Head of Clinical Development and Chief Medical Officer at Sanofi. Sanofi has been actively implementing policies and protocols of its own to accelerate diversity in its clinical trials.

Below is an excerpt from our conversation.

Janice: Clinical research is foundational in developing and advancing innovative medicines, yet certain minority groups continue to be under-represented in clinical research. How is Sanofi working to increase diversity in its clinical trials?

Dietmar: As an industry, we have a lot of work to do. According to a 2020 U.S. Food and Drug Administration (FDA) report, globally, 75% of all clinical trial participants are white. Without diverse participation in clinical trials, it is difficult to understand the impacts of race, ethnicity, and gender in how the human body responds to medicines – and those insights are very important.

Our objective is to increase, year over year, the percentage of Sanofi clinical studies meeting diversity targets. We are setting enrollment goals based on disease population demographics. To achieve our targets, we are looking at the entire ecosystem – from protocol development and eligibility criteria to site selection, recruitment materials, and engagement with local communities and patient advocacy groups. We are focusing on the United States first, working with several study teams to pilot our efforts.

Janice: This is such an important issue. What are some examples of how you’re putting this into action?

Dietmar: Absolutely. For example, we created the Sanofi Clinical Trials Inclusion & Diversity Project. The project’s overarching goal is to help teams ensure trial populations reflect the demographics of the disease for which treatments are being developed. We are exploring ways to identify and start up new trial sites – as well as working with our existing sites – to help them develop the ability to recruit and retain diverse participants.

I know this will take time and hard work, but we must be ambitious in setting our objectives. We must stretch and challenge our current approach and way of thinking.

Janice: What are the biggest challenges to increasing diversity in clinical trials?

Dietmar: There are many reasons why an individual may not participate in a clinical trial, including mistrust, stigma, lack of access to information, financial constraints, fear, geography, and narrow eligibility criteria. In addition, other important factors can play a role in excluding people from participating in clinical trials, e.g., disparities based on ethnicity, gender or other factors, socioeconomic status, as well as forms of unconscious bias.

These are certainly all complex and serious challenges. But I believe that building trust with diverse patient communities is our biggest challenge to achieving our goals. To that end, we are working with patient advocacy groups and other external partners to build awareness, understanding, and collaboration.

Janice: How can anyone interested contribute to this mission?

Dietmar: TransCelerate has previously released tools and information that advise on diversity awareness for sites and sponsors. Most recently, fellow TransCelerate Board of Director member, Kate Owen, published a blog post on “Seven Ways to Diversify Patient Populations in Clinical Trials.” It is full of actionable items that sponsors, sites, Health Authorities, and other stakeholders can use and work together to improve the clinical trial experience for patients.

By sharing best practices and developing multi-year programs committed to improving diversity in clinical trials, TransCelerate’s 20 Member Companies are working diligently with investigators, Regulatory Authorities, R&D consortia, and other stakeholders to improve patient outcomes for all and deliver new medicines to patients faster. Keep an eye on this space for our future series on how TransCelerate is hoping to make its impact on the diversity of participants in clinical trials.

Janice Chang is the Chief Operating Officer at TransCelerate BioPharma Inc.  Janice has been involved with the organization since its inception.  In her current position, Janice works closely with the CEO and the Board of Directors to shape the long-term strategic vision and priorities for the organization and its 30+ initiatives. Janice defines and guides TransCelerate’s overall external engagement strategy with global health authorities, governmental agencies, industry groups, and TransCelerate’s country network spanning across 30 countries.  She has accountability overseeing TransCelerate’s corporate operations and works closely with her team to drive strategic delivery of TransCelerate’s portfolio.