Speeding Innovation with Real-World Evidence

Today's guest blog comes from Kimberly Blackwell, M.D., vice president, Early Phase Clinical Development and Immuno-Oncology at Lilly

When facing cancer, time is rarely on a patient’s side.

That’s why it’s critical to use every tool at our disposal to accelerate our research process. Increasingly, these tools are digital, relying on the growing reservoirs of data and computing power to analyze relationships between genetic markers and tumor behavior. I recently joined a panel of health care experts at an event hosted by Friends of Cancer Research (FOCR) to discuss real-world evidence and the powerful ways we’re leveraging data to drive advances for cancer patients.

Real-world evidence, or RWE, is data from sources such as electronic health records, insurance claims or patient registries, which can help us understand the impact treatments have on patients outside of clinical trials.

To be clear, RWE is not a substitute for clinical trials data; rather, it complements these data by providing additional context to help us better understand how well a treatment works for patients.

Historically, RWE has been used to evaluate medicines after they are approved by the U.S. Food and Drug Administration (FDA), a procedure known as “post-approval” evaluation. Today, however, RWE plays a central role throughout the drug development process, including shaping early drug discovery efforts.

As cancer treatments become more individualized, researchers have begun to rely on molecular testing to understand which patients will benefit from a treatment—rather than use a “one size fits all” approach.

When developing new targeted therapies, RWE helps us match the genetic markers we find in some in tumors with the potential treatments most likely to make an impact. Working backwards, RWE can also help identify the patients who don’t respond to standard treatment options, and more quickly focus our research on opportunities that may work better for them.

Additionally, RWE can be used to help identify patterns of response earlier, which helps differentiate whether a potential therapy is truly effective at treating disease, or if the changes we observe during the study are the result of other causes, such as genetics, environment, lifestyle factors, etc.

Moreover, RWE helps us understand how our medicines affect patients throughout their entire cancer journey, including the impact of treatments on patient sub-populations that may not be included in clinical trials.

Lilly Oncology has steadily expanded our use of RWE during the research process. We also anticipate this trend will continue as we find new uses for these data.

As with any evolving technology, RWE is not without challenges, such as the sporadic quality of data sources like electronic health records, or certain regulatory barriers. However, stakeholders throughout the industry, including the FDA, have made huge progress in addressing these gaps, and the future looks even more exciting.

As a cancer researcher, I approach every day understanding that time is of the essence when combatting this complex disease. Real-world evidence has countless impacts, and at Lilly Oncology, we are committed to growing our efforts and exploration of how it can help us deliver better outcomes for patients faster.