COTA’s medical and scientific teams recently participated in the 8th Annual Friends of Cancer Research Blueprint for Breakthrough Forum in Washington, DC with various stakeholders across the regulatory and real-world evidence (RWE) landscape. The event was an opportunity to discuss the RWE pilot study 2.0 - a collaborative effort between COTA, Friends of Cancer Research (Friends), and nine other industry organizations exploring the opportunities and limitations of real-world endpoints.
COTA’s vice president of HEOR, Daniel Lane and director of analytics, Eric Hansen share their conference highlights and takeaways.
The results of the pilot study showed alignment across different data sources and datasets even though companies were sourcing data differently - through EHRs, claims, tumor registries, and the like. This consistency helps prove the validity of real-world data (RWD) across applications, spurring a need to understand the broad range of ways it can be used to support clinical research.
Panelists and audience members agreed that RWD is critical and will play an increasingly important role in drug development, patient care, and reimbursements. While progress is being made, there is still a considerable amount of work to be done and questions to be answered. Stakeholders must collaborate to establish data quality standards and consistent definitions of real-world outcomes as well as identify areas of bias in RWD.
The companies included in the pilot study and those that participated in the analysis portion of the event are often considered to be competitors. However, through this collaboration, it became clear that we share similar challenges and there is a willingness to share expertise to expand the understanding and acceptance of RWD. There was consensus that we have a collective responsibility to advance the use of RWE to improve patient outcomes. The panelists used the phrase “frenemies” to describe the companies involved in this research, as did the audience on social media, noting the importance of putting “normal” business practices aside to advance cancer care for the benefit of patients.
Keynote speakers, including Associate Director at the FDA’s Oncology Center of Excellence, Sean Khozin, MD, MPH, continued to push attendees even further in their company missions, asking: “what is data quality,” and “what threshold is good enough,” in regards to RWD for regulatory use. Other thought-provoking questions included: “how do we find patient populations that are similar?” or “where can I find data about patients that are just like me?”
But it was Dr. Amy Abernathy, Principal Deputy Commissioner, FDA who ended her session on the most promising note, publicly announcing the Technology Modernization Action Plan to modernize the FDA’s technology infrastructure. This plan will essentially boost cloud capabilities and data analytics to support RWE in regulatory decision making. The announcement demonstrated that the agency is proactively preparing to understand and critically review the influx of new RWD and RWE, expected as a result of recent and upcoming guidance on RWD use.
RWD has the potential to dramatically impact the pace of drug development. While there is still progress that needs to be made and questions to be answered across the industry, the forum affirmed COTA’s important role in helping to establish regulatory-grade data standards to drive innovation and allow for future collaboration with frenemies and partners alike.
In case you missed COTA’s previous announcement on the Friends collaboration, you can view it here.