September 30, 2024 – Cardinal Health’s Real-World Evidence and Insights team has completed research designed to advance the reliability of real-world evidence (RWE) for regulatory decision making. The research was funded by the U.S. Food and Drug Administration (FDA), which awarded the RWE team a $750,000 contract in 2021. With the funding, Cardinal Health evaluated real-world data (RWD) for lymphoma tumor response assessment compared to blinded independent central review, the gold standard in clinical trials. The novel method is called real-world Lugano (rwLugano) and corresponds to Lugano 2014, the criteria used in clinical trials to classify lymphoma treatment response.
The use of RWE may ultimately support patient access to safe and effective therapies, but only if the potential is fully realized by bridging the measures used in clinical trials to corresponding endpoints in real-world patients. The Real-World Evidence team completed their research this year, finding that their rwLugano method of measuring response to lymphoma therapy appeared more accurate than the standard approach used in most studies.
RWE is the clinical evidence about the use and potential benefits or risks of a medical product derived from analysis of RWD, which the FDA defines as data about patient health status and/or the delivery of healthcare that is routinely collected from a variety of resources, such as data from electronic health records or medical claims data. The RWD for this study was abstracted from patient medical records via a physician-led chart review.
RWE varies from clinical trials, which are the gold standard for determining medical product safety and efficacy and gaining FDA approval. Clinical trials are done in controlled environments to assess various therapeutic interventions. They’re built on rigorous protocols using carefully screened volunteers. The volunteers tend to be younger, less diverse, and healthier than the population as a whole – and therefore, their results may not reflect medical care for those patients outside the study. A patient’s age, race, gender, ethnicity and other personal, cultural and environmental factors can cause the patient to have a different experience to the same treatment from the clinical trial volunteers.