rw-Response Pilot Project
What endpoints can be evaluated and compared across multiple data sources using a common framework?
What is the unmet need and why does it matter?
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 data, 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 (i.e., scan, blood test, other) and frequency of evaluation, are not consistently available in RWD.
How are we helping to find solutions?
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.
How does this impact patients?
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.
Project Outcomes
Friends prioritizes sharing findings from our projects with the public to inform policy:
Friends Led Peer Reviewed Literature
McKelvey BA, Garrett-Mayer E, Rivera, DR et al. Evaluation of Real-World Tumor Response Derived From Electronic Health Record Data Sources: A Feasibility Analysis in Patients With Metastatic Non–Small Cell Lung Cancer Treated With Chemotherapy. JCO Clinical Cancer Informatics 2024. https://ascopubs.org/doi/10.1200/CCI.24.00091.
Friends Public Meetings
In September 2023, Friends hosted a meeting to share the results from the Friends real-world Response (rw-Response) Pilot.
Presentations
In June 2023, Friends presented a poster about the rw-Response findings at the ASCO Annual Meeting.
Project Partners
Ambra Health, American Society of Clinical Oncology (ASCO), Columbia University, ConcertAI, COTA Healthcare, U.S. Food and Drug Administration (FDA), Flatiron Health, Guardian Research Network, IQVIA, Ontada, Syapse, Tempus AI.