Pivotal study to inform framework for how to use RWE to support regulatory and reimbursement decisions
IRVING, Texas–(BUSINESS WIRE)–McKesson is pleased to announce that it is participating in Phase II of the Friends of Cancer Research (Friends) Real-World Evidence (RWE) pilot project to advance the understanding and inform future uses of RWE.
The initial Friends’ RWE pilot project demonstrated that different datasets could be used to extract several real-world endpoints in a relatively consistent manner. In order to further characterize the role real-world endpoints may play in measuring treatment effect size, pilot project 2.0 will examine the ability of different real-world endpoints to detect treatment effectiveness in real-world patient populations. Additionally, data from this pilot project will help inform a framework containing key data elements, endpoint definitions, and algorithms that could be applied to other datasets representing different therapeutic areas and disease types.
“We believe real-world data and real-world evidence play and will continue to play an important role in regulatory decision making,” said Sarah Alwardt, PhD, vice president of Operations for McKesson Data, Evidence & Insights. “This project with Friends investigates a key concern: understanding clinical endpoints in real-world data. We know that clinical trials alone will not be sufficient to accelerate desperately needed advances in cancer care, and that by establishing common definitions with cross-industry partnerships, we can further take ground. We are so excited to collaborate with Friends and our other healthcare colleagues participating in this important project.”
“RWE is an important tool for continued learning about treatment outcomes over time,” said Dr. Jeff Allen, president & CEO of Friends. “This partnership explores the potential use of different endpoints derived from electronic health data and demonstrates how different data sources can reproducibly provide important information on patient populations often excluded from clinical trials.”
McKesson Data, Evidence & Insights uses robust regulatory-grade data to deliver meaningful, timely insights so informed clinical, regulatory, commercial and payer strategy decisions can be made. McKesson leverages iKnowMedSM, its oncology practice electronic health record (EHR) system, as well as reimbursement data from integrated structured retrospective and prospective databases. Using this innovative model, biopharma and life sciences companies are able to bring life-saving drugs to market faster and support rapid label expansion, as well as create commercialization plans and outreach strategies to support appropriate utilization of commercial products.
About Friends of Cancer Research
Friends of Cancer Research (Friends) drives collaboration among partners from every healthcare sector to power advances in science, policy and regulation that speed lifesaving treatments to patients. For more information, please visit www.focr.org.
About McKesson Corporation
McKesson Corporation, currently ranked 7th on the FORTUNE 500, is a global leader in healthcare supply chain management solutions, retail pharmacy, community oncology and specialty care, and healthcare information technology. McKesson partners with pharmaceutical manufacturers, providers, pharmacies, governments and other organizations in healthcare to help provide the right medicines, medical products and healthcare services to the right patients at the right time, safely and cost-effectively. United by our ICARE shared principles, our employees work every day to innovate and deliver opportunities that make our customers and partners more successful — all for the better health of patients. McKesson has been named the “Most Admired Company” in the healthcare wholesaler category by FORTUNE, a “Best Place to Work” by the Human Rights Campaign Foundation, and a top military-friendly company by Military Friendly. For more information, visit www.mckesson.com.
Claire Crye, Public Relations