On October 15, 2019 Aetion and McKesson reported a strategic collaboration focused on advancing the use of real-world evidence (RWE) in cancer research to benefit patients, regulators, the biopharma industry, and payers (Press release, McKesson, OCT 15, 2019, View Source [SID1234542278]). The partnership will provide best-in-class solutions in multiple tumor types, including breast, lung, and melanoma cancers.
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The joint solutions combine the Aetion Evidence Platform with data from McKesson’s iKnowMedSM oncology electronic health record (EHR) system to power regulatory-grade outcomes research. They will first be made available to the team of researchers at Brigham and Women’s Hospital who are leading the Food and Drug Administration (FDA) demonstration project, RCT DUPLICATE, in order to replicate oncology randomized controlled trials (RCTs) with real-world data. Aetion and McKesson are also both part of the Friends of Cancer Research Real-World Evidence pilot project to assess several frontline treatment regimens in real-world patients with advanced non-small cell lung cancer (aNSCLC), which will inform the FDA’s acceptance of real-world evidence for drug approvals.
"This collaboration is an important step in informing rigorous standards for regulatory-grade data and analysis. Our goal is to get therapies to market faster to help life sciences companies and drive better health for patients," said Derek Rago, vice president and general manager of Oncology Data, Evidence, and Insights at McKesson Life Sciences. "Based on the ability of observational studies to gain insight into treatment patterns and outcomes in clinical practice, the FDA is supportive of the expanded use of RWE to inform a variety of regulatory decisions."
The solutions allow users to conduct regulatory-grade studies in major cancers and accelerate time to insight on oncology data. It also enables researchers to develop evidence for synthetic control arm and label expansion studies, to fulfill post-marketing safety requirements, and to assess the economic impact of treatments.
"Combining our real-world evidence platform with McKesson’s cancer data accelerates time to insight when conducting oncology analyses," said Carolyn Magill, CEO of Aetion. "This collaboration enables us to provide researchers with the tools to advance cancer research with greater efficiency and precision."
McKesson’s iKnowMed was named the top-ranked EHR platform for oncologists and hematologists for the eighth year in a row by Black Book Research and is ONC Health IT certified. By joining Aetion’s scientifically-validated RWE platform with McKesson’s best-in-class data, the offering enables faster and more cost-effective regulatory-grade cancer research.
Expanding the possibilities for cost-effective cancer research through RWE meets a pressing need. In 2018, biopharma invested $50 billion to support oncology research and development, with an approximate three percent probability of success for any individual product. Real-world evidence can provide critical information about treatments while reducing the costs and time of developing a drug.