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An International Framework for Real-World Evidence – Day 1: RWE Pilot Project Results

An International Framework for Real-World Evidence – Day 1: RWE Pilot Project Results

September 21st was the first day of the Friends of Cancer Research (Friends) virtual meeting on real-world evidence (RWE). Day 1 covered findings from the RWE Pilot 2.0 Project, exploring the outcomes of patients with advanced non-small cell lung cancer (aNSCLC) treated with immunotherapy versus chemotherapy, as well as related RWE projects from partner institutions across the country and abroad. The meeting opened with welcoming words from Friends’ founder, Ellen Sigal, and an introduction from Friends’ President and CEO Jeff Allen, who provided background of the Friends RWE pilots and results of the RWE Pilot Project 2.0. The findings of this project showed that patients generally performed better on immunotherapy as opposed to chemotherapy.

Following the initial data presentation was a panel discussion on the findings and the future of RWE. The panel was moderated by Joe Henk of OptumLabs, and consisted of Elizabeth Garret-Meyer, ASCO; Sean Khozin, Janssen; Donna Rivera, FDA; and Nick Robert, McKesson Life Sciences. Topics of discussion included the optimization of real-world data, how to operationalize RWE outcomes, and challenges associated with the statistical analyses of real-world data. A recurring theme was the benefit of using RWE to supplement clinical trials and add to the collective knowledge about a drug. Looking forward, the panel discussed important next steps for RWE, including developing standards for reporting real-world data and fit-for-purpose datasets to address specific project objectives.

The second session of the day began with two presentations from collaborations that applied the RWE Pilot 1.0 framework to expanded, international populations and different cancer types. First, was Adam Reich presenting IQVIA’s findings, which applied the Friends RWE framework to the United Kingdom. They looked at data from the Cancer Analysis System (CAS, a nationally sourced data set within the United Kingdom). Their findings, based upon a dataset with near complete mortality data, were similar to the findings from the US analysis and supported the correlations between real-world overall survival (rwOS) and real-world endpoints in the RWE Pilot 1.0 analysis.  The second presentation was by Brigitte Dréno of CHU Nantes and Maxime He of Owkin. This collaboration applied the RWE framework to a cohort of melanoma patients in France, demonstrating applicability of the RWE framework in expanded oncology settings.

The last panel of the day was moderated by Mark Stewart of Friends, featuring Jennifer Christian of IQVIA in addition to Adam Reich, Brigitte Dréno, and Maxime He. They discussed the results, obstacles, and learnings of each project. They further iterated that RWE can be used to supplement clinical trial information, focusing on information gleaned from RWE not obtainable in clinical trials as RWE includes patients that would generally be excluded from traditional clinical trials. They also discussed future applications of real-world data, particularly how it can inform on cost-effectiveness assessments.

The meeting concluded with a few closing words from Jeff Allen, as well as a look toward Day 2 of the meeting, which focused more on the policy implications of RWE. A recording of both sessions can be found on the Friends YouTube channel.


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