Using Real World Evidence to Drive Outcomes in Diabetes Care
A pioneer in using real world evidence and large-scale data, Rachele Berria, MD, PhD, Head of US Diabetes Medical Affairs, is determined to help improve health outcomes for people living with diabetes.
Ever since leaving my homeland of Italy and arriving in the U.S. as a medical resident at the University of Texas Health Science Center, I have considered myself an evidence-based, data-driven physician and researcher. As a young clinician performing my rounds, I found myself constantly questioning proposed care decisions because I never believed in the logic “if this worked for me once then it must be the best approach for everyone.” Even then, I viewed data as the key to transcending our naturally biased lenses – to expand our vision past our own limited horizons – and uncover the true needs of patients. In retrospect, I was practicing what is now called a real world evidence based approach – a method that has become a key part of medical research over the last decade.
Real world evidence, or RWE for short, is described as the use of real world data and analytics to discover, develop, and deliver new insights about healthcare interventions. It can be derived from a variety of sources, such as electronic health records or hospital databases, and provides a better understanding of the value medical treatments offer to the patients who need them.
I’ve focused most of my career utilizing RWE to connect the dots that are not always obvious to individual healthcare professionals, or that sometimes are not apparent to all stakeholders across the healthcare value chain. RWE enables us to answer the same fundamental questions I had as a resident by providing proof that a treatment or care decision is likely to be effective and impactful at the population level.
At Sanofi, we are harnessing the power of RWE to complement randomized clinical trials through novel ways that study the effectiveness, safety and value of our products in a manner that can be more efficient than traditional research methods. One example is our LIGHTNING study which analyzed electronic medical records for over 5 million people with diabetes in the Optum-Humedica database. The study applied statistical techniques, such as propensity score matching and machine learning, which provided us with data on our insulins to better understand not only their efficacy, but also important safety information when compared to other treatment options.
Data from this study, and many other ongoing and completed studies, are then used to inform other stakeholders, like payers and regulators, in their decision-making processes to ensure people living with diabetes have access to the right treatments. It fills me with pride to work at a company that recognizes the potential of RWE and is dedicated to ensuring it becomes the disruptive force we know it can be.
As our team prepares to attend the American Diabetes Association 78th Scientific Sessions, I am thrilled to see this year’s congress will open with a symposium exploring how RWE is being used by forward-thinking organizations to transform diabetes care. This spotlight by the American Diabetes Association shows just how relevant this emerging research approach has become over the last few years.
As we look to the future, our ambition, fully shared by our Chief Medical Officer and his team, is to use RWE to drive transformation across the entire healthcare ecosystem. However, this cannot happen until specific guidance on the usage of RWE is put in place by regulatory authorities. The next step is for all stakeholders – patient advocates, healthcare providers, researchers, medical organizations, drug manufacturers and payers – to come together and work closely with regulatory authorities on clear, consistent guidelines on using RWE that complement classic clinical trials and lead to more informed treatment decisions for patients.