publication date: Nov. 22, 2019

Real-World Evidence

Real-world evidence at a glance:

How a collaboration of “frenemies” produced common definitions for real-world endpoints

By Matthew Bin Han Ong

Ten health care research organizations, with help from FDA and NCI, have developed a set of common definitions for real-world endpoints, including overall survival, progression-free survival, and other non-traditional endpoints.

The new common definitions are published as part of a pilot study led by Friends of Cancer Research, which announced the conclusions of this phase of the project at a recent gathering in Washington, D.C.

At the Sept. 18 event, the 8th Annual Blueprint for Breakthrough Forum, a speaker nicknamed the collaboration “Frenemies of Cancer Research.” The suggestion set off a wave of loud, albeit nervous laughter, because the joke was on the nose—to collaborate, many of these companies had to set aside their competitive agendas, which made for an uneasy peace.

The companies that participated in the Friends Pilot Project 2.0 are: Aetion, CancerLinQ, Concerto HealthAI, COTA, Flatiron Health, IQVIA, Kaiser Permanente, OptumLabs, McKesson Life Sciences, Syapse, and Tempus.

The Friends effort is central to realizing one of the primary mandates within the 21st Century Cures Act of 2016, which requires FDA to consider using real-world evidence to complement and supplement data generated through traditional clinical trials in drug regulation.

The project has one especially important patron. “FDA was instrumental in providing expertise throughout the entirety of the project, including its development,” Jeff Allen, president and CEO of Friends, said to The Cancer Letter.

Most of the companies involved in the Friends effort regularly compete against each other for grants, access to health systems, and funding from … Continue reading Real-world evidence at a glance: How a collaboration of “frenemies” produced common definitions for real-world endpoints

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