rw-Response Pilot Project

Real-world data (RWD)—data relating to a patient’s health status and the delivery of care routinely collected from electronic health records (EHR), claims and billing—can fill evidence gaps about the performance of therapies, including in populations that may be underrepresented or not included in clinical trials. However, the standardization necessary for reliable assessments of response, such as mode of evaluation (scan, blood test, other) and frequency of evaluation, are not consistently available in RWD. 

Friends worked with seven EHR-data vendors to answer the question: What endpoints can be evaluated and compared across multiple data sources using a common framework? The group established a framework for measuring overall response to treatment outside of a clinical trial and applied the framework across RWD sources to assess the availability and frequency of key data components necessary for measuring rw-response. By applying the aligned framework, the group found relative consistency of the measure across RWD sources in first-line chemotherapy regimens for patients with aNSCLC. 

Traditional clinical trials enroll only a narrow group of patients and take a long time, limiting their relevance to real-world populations. RWD-based endpoints, including rw-response, capture evidence from a broader, more diverse group and answer urgent questions about treatment effectiveness and safety in everyday practice.