Aetion Announces Partnership with the U.S. Food & Drug Administration and Brigham and Women's Hospital/Harvard Medical School to Integrate Real-World Evidence into Regulatory Decision-Making
Published: May 08, 2018
NEW YORK, May 8, 2018 /PRNewswire/ -- Aetion®, the software platform company delivering the real-world analytics and evidence needed for biopharma and payers to engage in value-based care, today announced its partnership with the U.S. Food & Drug Administration (FDA) and Brigham and Women's Hospital/Harvard Medical School to use its software platform to re-create randomized clinical trials (RCTs) through real-world evidence (RWE). This landmark study aims to demonstrate the value of RWE as an accelerant to drug approval, particularly for supplemental indications, and could revolutionize how drugs are developed, approved, and commercialized.
The 21st Century Cures Act and Prescription Drug User Fee Act VI require the FDA to develop guidance on how to integrate RWE into its regulatory decision-making. In this large-scale study, this FDA-sponsored research employs the Aetion Evidence Platform™ and is aimed at replicating the results of 30 published RCTs, to see whether the use of RWE would have led to the same regulatory decisions. The results will demonstrate whether RWE could be used to supplement or, in certain circumstances, even replace clinical trials for drug development and regulatory approval.
"We are honored to support this seminal work by the FDA and Brigham and Women's Hospital/Harvard Medical School, and to apply the Aetion Evidence Platform in exploring the potential of real-world analyses in advancing regulatory process for critical treatments," said Carolyn Magill, chief executive officer of Aetion. "Our software solution is widely used by biopharma companies and payers to evaluate the effectiveness, safety, and value of medications, and we are excited to demonstrate the benefit our platform can bring to drug development and regulatory decision-making on an even broader scale."
The Aetion Evidence Platform uses the everyday clinical and financial interactions of the health care system to unlock essential evidence about the effectiveness and value of treatments. Its validated, rapid-cycle analytics™ allows users to significantly reduce "time to evidence" and improve patient outcomes. Regulators appreciate the high transparency and audit trails provided by the platform.
"This project is a great step towards implementing real-world evidence for regulatory decision-making," said Jessica Franklin, Ph.D., assistant professor of medicine at Harvard Medical School. "We look forward to sharing the outcomes of our effort to replicate published RCTs to provide an empirical basis for regulatory rule making, and to further exploring how we can replicate clinical trials in which results are not yet known."
The three-year study began in fall 2017 and is funded by the FDA's Center for Drug Evaluation and Research and is led by the Office of Medical Policy. Now in its implementation phase, the group has identified 30 published trials that were used for FDA approval decisions and will now begin to analyze relevant real-world data assets. Of the 30 trials to be replicated (from four disease areas: cardiovascular, endocrinology, musculoskeletal, and pulmonary), 23 involved positive decisions, i.e., approvals, and 7 involved rejections.
Based in New York City, Aetion is a leading health care technology company that delivers the real-world analytics and evidence needed for pharmaceutical developers and purchasers to thrive in value-based care. With its patented rapid-cycle analytics technology, the Aetion Evidence Platform uses the everyday clinical and financial interactions of the health care system to unlock essential evidence about the effectiveness and value of medical treatments. Founded by Harvard Medical School faculty members and a big data pioneer, Aetion enables biopharma companies and payers to collaborate in real-time to develop therapeutic insights so patients get the most clinically effective -- and cost-effective -- care. Learn more at www.aetion.com.
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