RWE Pilot Projects
Real-World Evidence (RWE) Pilots 1.0 and 2.0, rw-Care Pilot
What is the best approach for evaluating real-world data (RWD) to generate real-world evidence (RWE) to identify drugs that benefit patients?
What is the unmet need and why does it matter?
Real-world data (RWD) captured in electronic health records (EHR) and claims data includes a wealth of data that can provide insights on patient outcomes in real-world populations and care settings; however, these data vary significantly in how they are defined and captured making it challenging to collect the consistent, quality data needed for reliable assessments.
How are we helping to find solutions?
Our RWE Pilot Projects developed frameworks and methodologies for capturing RWD across sources and explored the feasibility of implementing these frameworks to obtain insights from RWD:
- RWE Pilot 1.0 created a framework for aligning data sources and showed that implementing a harmonized protocol and standardized definitions for necessary data elements supports the identification of comparable 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-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.
How does this impact patients?
Aligning on frameworks for RWD assessment is a critical step toward reliable use of these data in clinical practice and regulatory decision–making. These frameworks can enable use of RWD for rapid insights on patient safety and treatment efficacy, providing timely information that supports better care for patients.
Project Outcomes
Friends prioritizes sharing findings from our projects with the public to inform policy:
Friends Led Peer Reviewed Literature
McKelvey BA, Berk A, Chin L et al. A Study Design to Harmonize Patient-Reported Outcomes Across Data Sets. JCO Clinical Cancer Informatics 2023; Volume 7. https://ascopubs.org/doi/10.1200/CCI.22.00161.
Rivera DR, Henk HJ, Garrett-Mayer E et al. The Friends of Cancer Research Real-World Data Collaboration Pilot 2.0: Methodological Recommendations from Oncology Case Studies. Clinical Pharmacology & Therapeutics 2021. https://doi.org/10.1002/cpt.2453.
Lasiter L, Tymejczyk O, Garrett-Mayer E et al. Real-world Overall Survival Using Oncology Electronic Health Record Data: Friends of Cancer Research Pilot. Clinical Pharmacology & Therapeutics 2021. https://doi.org/10.1002/cpt.2443.
Friends Public Meetings
Project Partners
RWE Pilot 1.0: COTA Healthcare, U.S. Food and Drug Administration (FDA), Flatiron Health, IQVIA, Kaiser Permanente/Cancer Research Network (CRN), Mayo Clinic & OptumLabs, and National Patient Centered Cancer Research Network (PCORnet)/University of Iowa.
RWE Pilot 2.0: Aetion, American Society of Clinical Oncology (ASCO) CancerLinQ & ConcertAI, COTA Healthcare, FDA, Flatiron Health, IQVIA, Kaiser Permanente, Mayo Clinic & OptumLabs, McKesson, National Cancer Institute (NCI) SEER-Medicare Linked Database, Syapse, Tempus AI.
rw-Care: Apricity Health, Carevive Systems Inc., Clinical Outcomes Solutions, Invitae, Navigating Cancer, Varian a Siemens Healthineers Company.