RELEASE: Aetion Leads the Initiative to Understand the Limits of Regulatory Use of Real-World Evidence

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RELEASE: Aetion Leads the Initiative to Understand the Limits of Regulatory Use of Real-World Evidence

(Information sent by the signatory company)

- Aetion leads cross-sector initiative to understand the strengths and limitations of regulatory use of real-world evidence

The Aetion CARE initiative aims to become the standard bearer for best practice and efficiencies in RWE development and decision making

NEW YORK, Nov. 29, 2022 /PRNewswire/ -- Aetion, the global leader in Real World Testing (RWE) technology and analysis, today announced the launch of the Coalition to Advance RWE through Emulation Initiative of Randomized Controlled Trials (CARE). The first phase of the Initiative will focus on oncology and involves a diverse group of partners, including AbbVie, Amgen, AstraZeneca, Bayer, Baylor College of Medicine, Brigham and Women's Hospital and Harvard Medical School, ConcertAI, Duke -Margolis Center for Health Policy, Friends of Cancer Research, Gilead, Loopback Analytics, Pfizer, Reagan-Udall Foundation, Tempus, TriNetX, and xCures.

The Aetion CARE initiative will focus on better understanding the types of regulatory questions that can be answered by RWEs and Randomized Controlled Trials (RCTs), as well as when and why RWEs and RCTs may yield the same or different results. The team will run multiple test emulations on various data sources, beginning with a one-year focus on oncology. Using the Aetion Evidence Platform®, the initiative will help identify when and how RWE can support the goals of promoting efficient access to medicines and improving patient care.

"If we've learned anything from the global COVID-19 pandemic, it's that no organization or industry should act alone when it comes to accelerating care and treatment options for people in need and improving public health globally," Lauren said. Becnel, Pfizer's vice president of real-world testing. "Thanks to Aetion's leadership, CARE Initiative participants will work together to drive real, tangible change in the way RWE can be leveraged in the oncology space and beyond."

"Data quality, accessibility and analytical tools are progressing at a rapid pace," said Carolyn Magill, CEO of Aetion. "We and our partners launched the Aetion CARE Initiative to promote global alignment on scientific methodologies to create real-world evidence and assist in its interpretation."

This initiative can further the knowledge developed in the RCT-DUPLICATE demonstration project. RCT-DUPLICATE suggested that, under certain circumstances, RWE studies can significantly complement RCT evidence or even replace some large-scale randomized safety trials. The RWE studies were particularly successful at emulating trials that examined the real-world setting by comparing one treatment with an alternative therapy. To ensure objectivity in the study design, a multi-stakeholder steering committee comprised of academic thought leaders, large biopharmaceutical manufacturers, and data providers will govern the project. Test emulation results for the Aetion CARE initiative will be delivered through 2023, with a process document to be released in Q4 2022. For additional information, visit https://aetion.com/resources/ care-initiative/.

About AetionAetion is a healthcare analytics company that provides real-world evidence for manufacturers, buyers and regulators of medical technologies and treatments. The Aetion Evidence Platform® analyzes real-world data to produce scientifically validated, rapid, and transparent answers about safety, efficacy, and value. Founded by Harvard Medical School faculty members with decades of experience in epidemiology and health outcomes research, Aetion informs healthcare's most critical decisions—what works best, for whom, and when—to guide development. product, marketing and payments innovation. Learn more at aetion.com and follow us @aetioninc.

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