Syapse and FDA Collaborate on Real-World Evidence for Oncology

Seth Augenstein
AUGUST 15, 2019


A new collaboration between a healthcare data firm and the U.S. Food and Drug Administration (FDA) aims at putting together real-world evidence in oncology — and bringing it to regulatory and clinical decision-making, according to a Wednesday announcement.

Syapse, the San Francisco-based firm, said the plan is to derive real-world evidence from electronic health records and other assorted sources — and make it into actionable insights.

The multiyear collaboration with the FDA Oncology Center of Excellence will find endpoints and impacts from new therapies for patients in the real world — “particularly those not represented in clinical trials,” said Sean Khozin, M.D., MPH, who is the associate director for oncology regulatory science and informatics in the FDA’s Oncology Center of Excellence.

“This is especially critical in precision medicine, where understanding all of the factors that may drive safety and response is both imperative and difficult to capture at scale using traditional clinical trials,” said Khozin, in a statement released by Syapse.

Their methodology for the program, based on the recent “Framework for FDA’s Real-World Evidence Program,” is to incorporate disparate sources of data together: clinical information from EHRs and registries, molecular data from testing labs, among other sources.

Endpoints for solid tumors and other malignancies will be characterized based on molecular testing, cross-referenced against the precision techniques used, they said.

Syapse will also directly engage oncologists through its Learning Health Network to understand outcomes, they added.

“The network of health systems that Syapse represents offers a unique opportunity to learn from oncology patient journeys and populations not well represented in traditional clinical trials,” said Jonathan Hirsch, founder and president of Syapse. (Hirsch was one of the speakers at last month’s FDA-AACR (American Association for Cancer Research) “Real-world Evidence Workshop.”)

Syapse, founded in 2008, has struck deals worldwide recently. Last week it announced a partnersghip extension with Seoul National University Hospital in South Korea. That deal also involves precision oncology, and involves more than 8,000 cancer patients in that country.

Just last month it also announced a strategic collaboration with Pfizer, also involving real-world evidence.

Other partners listed by Syapse include: Advocate Aurora Health Care, CommonSpirit Health, Henry Ford Health System, and Providence St. Joseph Health.

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