Aetion and McKesson have announced a strategic collaboration focused on advancing the use of real-world evidence (RWE) in cancer research. The goal of the collaboration is to benefit patients, regulators, the biopharma industry, and payers; it will provide best-in-class solutions in multiple tumor types, including breast, lung, and melanoma cancers.
The solution combines the Aetion Evidence Platform™ with data from McKesson’s IKnowMedSM oncology electronic health records (EHR) system to power regulatory-grade outcome research. The first organization to whom the solution will be made available is the team of researchers at Brigham and Women’s Hospital who are leading the FDA demonstration project, RCT DUPLICATE, in order to replicate oncology randomized controlled trials (RCTs) with real-world data.
Aetion and McKesson are both part of the Friends of Cancer Research Real-World Evidence pilot project, which will assess several treatment regimens in real-world patients with advanced non-small cell lung cancer, which will inform the FDA’s acceptance of real-world evidence for drug approvals.
“Combining our real-world evidence platform with McKesson’s cancer data accelerates time to insight when conducting oncology analyses,” said Aetion CEO Carolyn Magill. “This collaboration enables us to provide researchers with the tools to advance cancer research with greater efficiency and precision.”
The solutions allow users to conduct regulatory-grade studies in major cancers and speed the production of results from the data. They also enable researchers to develop evidence for synthetic control arm and label expansion studies, fulfill post-marketing safety requirements, and assess the economic impact of treatments.
“Based on the ability of observational studies to gain insight into treatment outcomes in clinical practice, the FDA is supportive of the expanded use of RWE to inform a variety of regulatory decisions,” said Derek Rago, vice president and general manager of oncology data, evidence, and insights at McKesson Life Sciences. “This collaboration is an important step in informing rigorous standards for regulatory-grade data and analysis.”
Read the full press release here.
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