Leading Real-World Data and Analytics Organizations Form Industry Coalition to Advance Policies to Support Regulatory Use of Real-World Evidence

McKesson Ventures portfolio company Aetion is one of the five real-world data (RWD) and analytics organizations that have banded together to form the RWE Alliance, an industry coalition dedicated to advancing the use of real-world evidence (RWE) to support regulatory decisions. The other members of the Alliance are Flatiron Health, IQVIA, Syapse, and Tempus.

The RWE Alliance intends to engage with the FDA and Congress to advocate for policies that advance the use or RWE in regulatory decision-making and benefit patients. The RWE Alliance will collaborate with patient groups, biopharmaceutical and medical device companies and their trade associations, as well as other key stakeholders, to support broader efforts around the use of RWE.

Both the FDA and Congress have recognized that RWE has the potential to increase knowledge about new treatments and vaccines to benefit public health. Congress included policies to advance the use of RWE in the 21st Century Cures Act, and the FDA has taken steps to explore the use of RWE for regulatory decision making, including by issuing a framework for the agency’s RWE Program and by engaging in multiple RWE-focused research collaborations, including a partnership with Aetion to use real-world data to advance the understanding of and response to COVID-19. The RWE Alliance intends to contribute to these and similar efforts, and to engage with the FDA on its 2021 Guidance Agenda and 2022 user fee authorization.

“Events of the past year have made clear that evidence derived from RWD is critical to assessing the safety, effectiveness, and value of drugs, vaccines, devices, and diagnostics,” said Aetion CEO Carolyn Magill. “The Alliance will help advance global RWE standards that reflect the utmost commitment to scientific credibility.”

Read the original press release here.