Real-World Evidence Portfolio

Real-World Data (RWD) is patient data routinely collected in electronic health records (EHRs), claims data, and registries that can provide valuable information about the real-world performance of cancer therapies and diagnostics. Unlike in traditional clinical trial settings where data are collected at pre-established timepoints and reported uniformly for trial participants, there is typically a lot of variation in the way RWD are reported within and across sources. Inconsistent definitions and data missingness in RWD present challenges to using these data sources to investigate treatment effectiveness, such as how a therapy impacts survival or can be used in certain patient populations. Strategies and methodologies for mitigating these factors and aligning RWD are needed to fully realize its potential.

Since 2017, Friends has facilitated collaboration among RWD vendors, pharmaceutical companies, government officials, and academics to advance the understanding and applications of RWD and real-world evidence (RWE) in oncology. These multistakeholder partnerships support alignment on best practices, provide a venue to develop and test methodologies for aligning and analyzing RWD, and help identify opportunities to proactively strategize on future use of RWD/E in oncology:

RWE Pilot 1.0 created a framework for aligning data sources and showed that implementing a harmonized protocol and set of definitions for necessary data elements supports identification of similar patient populations across data sources and extraction of several real-world endpoints.

RWE Pilot 2.0 applied the framework developed in Pilot 1.0 and showed that RWD can generate similar results to clinical trials when measuring the treatment effect of chemotherapy compared with immunotherapy in patients with advanced non-small cell lung cancer (aNSCLC). The group developed a list of considerations for the design, conduct, and interpretation of RWD studies from different data sources.

rw-Response established a framework for measuring rw-response to treatment and found relative consistency of the measure across RWD sources in first-line chemotherapy regimens for patients with aNSCLC.

rw-Care developed a framework for the use of RWD at point of care to improve patient outcomes from immunotherapy by mitigating treatment-related adverse events.

Traditional clinical trials, such as randomized controlled trials (RCTs), can take a long time and typically enroll a narrow patient population that represents a fraction of the patients who will likely receive the product in the real world. RWD can generate supplemental evidence that reflects a larger and more diverse patient population than is included in clinical trials and address timely clinical questions including use of different treatments in standard of care practice and long-term safety. Without Friends coordination and support from collaborative sponsors, groups may never agree on a solution for aligning best practices and frameworks for aggregating and analyzing RWD.