During the American Society of Clinical Oncology (ASCO) Annual Meeting in June, Friends of Cancer Research (Friends) convened rw-Response Pilot participants to discuss initial findings. This pilot expands on Friends’ previous real-world evidence (RWE) work focused on answering the question: “What real-world endpoints can be evaluated and compared across multiple data sources using a common framework”? Real-world data (RWD) are data related to a patient’s health that are routinely collected from electronic health records, claims, and billing. These data can potentially fill evidence gaps about the performance of therapies used in the real-world setting, including populations that may not have been represented in clinical trials.
In clinical trials, response endpoints, such as overall response rate, provide valuable details about therapeutic efficacy. However, multiple standardized measures are needed to evaluate response, such as the mode and frequency of evaluation, which are not consistently available in RWD. The goal of the rw-Response pilot is to establish and evaluate a uniform framework for measuring clinical response to treatment in RWD across multiple data sources to inform ongoing regulatory discussions on the use of RWD.
The rw-Response pilot includes seven companies who will provide RWD for a total of 1,400 patients with metastatic non-small cell lung cancer treated with first-line platinum doublet chemotherapy regimens. This pilot will assess the availability and frequency of core data components for measuring rw-response (e.g., images, image reports, clinician notes) and evaluate the consistency of measuring rw-response across data sources.
During the June meeting, pilot participants shared initial data on the demographic and clinical characteristics of the pilot cohorts to compare across datasets. The group discussed opportunities for further analyses and planned next steps of the pilot, which include completing the assessment of the availability and frequency of the core data components for measuring rw-response by the fall.
Thank you to our Pilot Participants for joining us:
ASCO, ConcertAI, COTA, FDA, Flatiron Health, Guardian Research Network, IQVIA, Ontada, Syapse, Tempus
To learn more about our Real-World Evidence work, please visit our project page.