RWE Pilot Projects
Real-World Evidence (RWE) Pilots 1.0 and 2.0, rw-Care Pilot
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.
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.
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
2023
- A manuscript developed by the rw-Care working group described the challenges and opportunities for aligning electronic patient reported outcomes data to generate RWE was published in JCO CCI.
2021
- Results of the RWE Pilot 2.0 were published in Clinical Pharmacology and Therapeutics:
2020
- The 2020 white paper, Considerations for Use of Real-World Evidence in Oncology: Lessons Learned from Friends of Cancer Research Collaborations, identified the implications of dataset variability on measuring real-world endpoints and provided recommendations for developing a framework to guide future RWE studies through a harmonized protocol.
- In September, Friends hosted a virtual event titled, “An International Framework for Real-World Evidence,” where the results of the RWE Pilot 2.0 were shared and potential policy and regulatory needs were discussed.
2018
- Friends hosted a public meeting titled The Future Use of Real-World Evidence on July 10. The meeting white paper, Establishing a Framework to Evaluate Real-World Endpoints, detailed Pilot 1.0 and a framework for operationalizing and validating real-world evidence in advanced NSCLC.
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.