New Findings Released – RWE Pilot 2.0 Project

Andrew Belli
October 23, 2020
Andrew Belli, MPH

friends of cancer research logoIn 2018, COTA joined nine other healthcare research organizations and stakeholders in a collaborative effort to advance the collective understanding in the applications of real-world data Pilot 1.0)  – led by Friends of Cancer Research (Friends). In the past, we have playfully dubbed this collaboration as one of “frenemies,” highlighting how companies that are often considered competitors can work together and share expertise for the common good of advancing the understanding and applications of RWE in oncology care. In 2019, the group embarked upon the second iteration of our collaborative research project (RWE Pilot 2.0), in an effort to generate further insights in non-small cell lung cancer (NSCLC) with a particular focus on novel treatment strategies. The findings of Pilot 2.0 were recently presented at a two-day event – An International Framework for Real-world Evidence.

Updated Results Support Validity of RWE

The Cancer Letter covered the most recent phase of RWE Pilot 2.0 – which focused on outcomes for real-world patients with NSCLC who received immune checkpoint inhibitors. The real-world data partners assessed the utility and validity of real-world endpoints across three NSCLC cohorts based on first-line therapy. The results of RWE Pilot 2.0 showed generally that the benefit obtained from immuno-oncology treatment in the real-world is directly similar to outcomes in a clinical trial. 

In addition to sharing these results, the event also included panels that discussed topics such as optimization of real-world data, the benefit of using RWE to supplement clinical trials, and next steps for RWE. Similarly, presenters also shared how they had applied the RWE Pilot 1.0 framework in an international setting and within different cancer types. Including how the RWE framework applied to a cohort of melanoma patients in France demonstrated applicability in expanded oncology settings, which was presented by Brigitte Dréno of CHU Nantes and Maxime He of Owkin. To close out the panel, Friends and IQVIA discussed future applications of RWD and how it can inform on cost-effective assessments. 

During the second day, participants focused on how findings from projects such as these and others in the industry can inform future drug development and regulatory decision making. Most notably, Dr. Amy Abernethy from the FDA spoke on the COVID-19 Evidence Accelerator that COTA is a partner in – led by the Reagan-Udall Foundation for the FDA and Friends. The project highlights the critical role of RWE during the ongoing pandemic. Visit Friends’ website to learn more about Day 1 and Day 2 of the event.

Understanding Industry Applications for Real-World Data Sources

Friends has published a white paper that provides an overview of the RWE collaboration, important findings from our data, and considerations for the development of a RWE framework. The findings and lessons learned from Pilot 2.0 highlight the importance of transparency and standardized methodology when working with RWD. Given the amount of potential variability among data sources in the real-world setting, particularly when working with multiple data partners (i.e. EHR-based vs. claims-based), it is important to follow a framework such as the one developed in Pilot 2.0 to ensure the RWD are fit-for-purpose. The lessons learned and output from these industry-wide (and now international) collaborations are extremely important to help move the RWE industry forward. 

COTA is incredibly proud to be a partner in this work, helping to drive improvements in cancer care through the understanding of RWD and RWE. Collaborations such as the Friends Pilot Project continue to uncover findings that might otherwise go unknown. We look forward to continuing to work with our “frenemies,” and drive innovation for the greater good. Stay tuned for future findings from this collaboration and more on our blog.