Inclusion and diversity in clinical trials is critical to Sanofi’s success.
Our company-wide Policy Position on Diversity in Clinical Trials lays out our belief that all individuals should have the opportunity to be included in our clinical studies, particularly people from diverse populations who are often under-represented in clinical research.
Our Policy Position also affirms our responsibility to recognize and seek to understand any differential in efficacy or safety within diverse populations.
According to a 2020 U.S. Food and Drug Administration (FDA) report, 76% of all clinical trial participants globally are white.
There are many reasons why an individual may not participate in a clinical trial, including mistrust, stigma, lack of access to information, financial constraints, and fear. Diverse populations also report that we simply do not ask them to participate. Structural barriers such as socioeconomic status, geography, and narrow eligibility criteria, as well as forms of unconscious bias, may also exclude people from participating in clinical trials.
Our objective is to increase, year on year, the percentage of Sanofi clinical studies meeting their diversity targets. We are setting enrollment targets based on disease population demographics. To achieve these targets, we are looking at the entire ecosystem – from protocol development and eligibility criteria to site selection, recruitment and retention materials, and engagement with local communities and patients of color. We are focusing on the United States first, working with several study teams to pilot our efforts.
The overarching goal of the Sanofi Clinical Trials Inclusion & Diversity Project is to help teams ensure trial populations reflect the demographics of the disease for which treatments are being developed. To that end, we are developing tools, leveraging digital technologies, seeking to learn from the external environment, and exploring ways to identify and stand up new trial sites – as well as working with our existing sites – to help them develop the ability to recruit and retain diverse participants.