RWE strengths and limitations for decision making: Aetion announces CARE Initiative cross-industry coalition

Aetion announces it will lead a cross-industry coalition, the CARE Initiative, to drive global best practices in leveraging RWE for regulatory decision making through test emulation of randomized controlled trials.

In a November 2022 press release, RWE technology and analytics company Aetion announced the launch of the CARE Initiative: the Coalition for the Advancement of RWE through Randomized Controlled Trial Emulation. The aim of this cross-industry coalition is to help identify when and how RWE can support the goals of advancing efficient access to medication and improving patient care.

“If we learned anything from the COVID-19 global pandemic, it’s that no one organization or industry should go it alone when it comes to expediting care and treatment options for people in need and to improve public health at a global level,” said Lauren Becnel, VP of Real-World Evidence at Pfizer. “Thanks to Aetion’s leadership, participants in the CARE Initiative will work together to drive real, tangible change in how RWE can be leveraged in the oncology space and beyond.”

Using the Aetion Evidence Platform®, the CARE Initiative will focus on better understanding the types of regulatory questions that can be answered using RWE and randomized controlled trials (RCTs), as well as when and why RWE and RCTs might yield the same or different results. This initiative will further the insights developed in the prior RCT-DUPLICATE project, which indicated that RWE studies can meaningfully supplement RCT evidence or even replace some large-scale randomized safety trials — the RWE studies were particularly successful in emulating trials that themselves examined the real-life scenario of comparing a treatment to an alternative therapy.

The coalition team will conduct multiple trial emulations in various data sources, beginning with a one-year focus on oncology. To ensure objectivity in study design, a multi-stakeholder steering committee composed of academic thought leaders, large biopharma manufacturers, and data providers will govern the project. The first phase of the initiative involves a group of diverse partners including AbbVie, Amgen, AstraZeneca, Bayer, Baylor College of Medicine, Brigham and Women’s Hospital, Harvard Medical School, ConcertAI, Duke-Margolis Centre for Health Policy, Friends of Cancer Research, Gilead, Loopback Analytics, Pfizer, Reagan-Udall Foundation, Tempus, TriNetX and xCures.

“Data quality, accessibility, and analytical tools are progressing at a rapid pace,” said Carolyn Magill, CEO at Aetion. “We and our partners launched the Aetion CARE Initiative to advance global alignment on scientific methodologies to create real-world evidence and aid in its interpretation.” Trial emulation results for the Aetion CARE Initiative will be delivered through 2023, with a process paper targeted to publish at the end of 2022.