FDA partners with Syapse to study regulatory use of real-world evidence
The U.S. Food and Drug Administration's Oncology Center of Excellence is embarking on a multi-year research partnership with Syapse, the developer of precision medicine technology. The collaboration centers around how to better use of real-world evidence to support regulatory decisions.
WHY IT MATTERS
Syapse will work with OCE – and other stakeholders across the agency – on regulatory issues around testing and treatment patterns, dosing and safety and oncology outcomes, the company says.
Together, Syapse and the FDA will explore new methods to gain RWE data from multiple sources, including electronic health records, molecular data from testing labs, claims and more. They'll focus on the regulatory suitability of RWE derived from such a multi-source approach.
In addition, they'll seek real-world endpoints for solid tumors and hematological malignancies, according to Syapse, exploring the clinical impact of molecular testing, seeking to better understand outcomes and adverse events for patients receiving precision medicines relative to clinical trial populations. They'll also look for new ways to incorporate patient-reported outcomes data into RWE sets.
THE LARGER TREND
Syapse says it will also engage oncologists in its Learning Health Network in joint outcomes research, enabling the use of real-world evidence by oncology care providers to inform care decisions and outcomes research; the company can then incorporate the outcomes derivation methodology into its Learning Health Network capabilities.
Other data-sharing networks have also been launched recently with a focus on RWE.
Just this week, Mercy Technology Services announced its new nationwide network, developed with SAP, to help healthcare stakeholders make better use of clinical data. The aim is to provide a network where providers can gain information to guide their own clinical and business strategies, and technology developers and regulatory agencies can also gain access to data that will fuel innovation.
And earlier this month, Cerner, in collaboration with Duke Clinical Research Institute, launched its new Cerner Learning Health Network, which aims to automate data collection from multiple sources, including electronic health records. The goal: Enable clinicians to more easily and efficiently gain health insights and guide care.
ON THE RECORD
"Advances in real-world evidence present an opportunity to learn from patients and potentially translate those insights into safer and more effective therapies," said Dr. Sean Khozin, associate director for oncology regulatory science and informatics in the FDA's Oncology Center of Excellence.
"Real-world evidence from well-designed studies meeting appropriate data quality standards can help to inform decision-making and provide information regarding the impact of new therapies in real-world patient populations, particularly those not represented in clinical trials," he added. "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."
"Advancing a deeper understanding of real-world endpoints and analytical methodologies is critical to assuring that all stakeholders can have confidence in the quality of evidence produced and accelerating the use of RWE in regulatory decision-making," said Jonathan Hirsch, founder and president of Syapse. "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."