Increasing Diversity in Clinical Trials: A Collaboration with Tufts Center for the Study of Drug Development

To effectively support the goal of access for all citizens, we must consider all citizens. But delivering on that goal takes a commitment to understanding deeply who patients are, their needs, and how we can best support positive health outcomes. We need to start at the beginning and build into every decision we make and step we take the diverse socio economic and individual health considerations of each person we encounter.

While medical advancements continue to be seen across most disease states, health outcomes are often dependent on factors beyond the control of patients and their doctors, such as disparities across age, gender, race, ethnicity, and socio-economic level. These disparities stem in part from inadequate representation in clinical trials to barriers to accessing care, among other factors. While the healthcare industry is working to close the disparity gap, as COVID-19 has clearly illustrated, we are not doing enough.

Four years ago we launched MS PATHS (Multiple Sclerosis Partners Advancing Technology and Health Solutions), a network of healthcare practitioners and neurologists to gather data from 17,000 patients from more than 50,000 patient visits to allow for a 360-degree disease assessment. While we are proud of the work we have done to support data driven evidence with that program, we know we need to do more. That’s why we recently collaborated and conducted a study with the Tufts Center for the Study of Drug Development (Tufts CSDD); the study investigated ways to potentially help improve a fundamental step in future healthcare outcomes - clinical trials. Working closely with Tufts CSDD and The Center for Information and Study on Clinical Research Participation (CISCRP), the team listened to, and learned from, patients, physicians, experts, and local community members about what it takes to remove the barriers patients face in joining clinical trials.

Biogen’s Global Clinical Operations Underserved Populations Champions Team (GCO UP Champions) is turning the study outcomes into action by implementing a series of practices with the goal of ensuring that our study participants represent the diversity of the communities where we engage in clinical trials in disease areas like lupus, multiple sclerosis, ALS, and Alzheimer’s. For example, building race and ethnicity recruitment target goals into the recruitment plans for U.S. clinical trials to better reflect the patient population and epidemiology of the disease is one such step. We are also forming a Community Advisory Board consisting of African Americans and Latinx members to co-develop meaningful and valuable clinical trial educational materials and tactics for underserved communities. Taking this one step further, we are building diversity and cultural sensitivity training for clinical trial sites we work with and focusing our efforts on clinical trial sites who are inclusive of diverse patient populations and underserved communities.

Working to overcome barriers to diversify clinical trials in the U.S. is only one of many steps to understand and address health disparities. Achieving health equity does not start and stop with clinical trials; it requires ongoing research at a global scale collaborating with leading institutions, like CISCRP and the National Minority Quality Forum (NMQF) to share key learnings and maintain an open dialogue. It requires focus and attention to the sustained relationships being built with the African American and Latinx communities.

Both inside and outside the U.S., there are many health disparities that go beyond race and ethnicity, such as economic, cultural, and geographic factors. We plan to leverage the learnings from diversifying our clinical trials in the U.S. to help us better understand the issues in other countries across the globe, followed by a targeted action plan.

At Biogen, we are committed to putting the weight of our business, our employees, and our collaboration partners to help close the disparity gap in clinical trials and access to healthcare.