Fact vs. Fiction: The Reality of Real-World Evidence/Data

Clinical trials typically recruit specific patients who fit certain criteria, inherently making them selective. These data from a limited population may not reflect how everyone will respond. Once therapeutic treatments are given regulatory approval, the true story begins to emerge about how the broader population responds, and this gets recorded in a variety of ways. From patient visits with providers to wearable monitoring devices, data points (taken together, real-world evidence/data or RWE/D) such as vital statistics and entries on electronic medical records (EMRs) are collected daily and can enlighten those who know how to access and analyze them.

Technology for analysis is constantly improving and will facilitate clinical trials when done optimally. Fitting historically limited patient populations into restrictive trial enrollment criteria can become easier. Trial design can use a feedback loop to ultimately enable faster accrual and facilitate the regulatory process. The data exist, both sponsors and CROs are opening their eyes to new possibilities, and it’s prime time to get ahead of this paradigm shift and learn how to make the most of RWE/D.