NEW YORK – Syapse said today that it has signed a research collaboration agreement with the US Food and Drug Administration's Oncology Center of Excellence to incorporate real-world evidence into regulatory decision-making.
Under the multiyear agreement, Syapse will lend its technology to the OCE to help various FDA stakeholders find answers to regulatory questions about oncology testing and treatment patterns, drug dosing and safety, and patient outcomes.
The San Francisco-based technology vendor and the FDA will study methods of collecting real-world evidence from electronic health records, molecular testing laboratories, patient registries, and other sources. They will attempt to characterize the "regulatory suitability" of this evidence, according to Syapse, as part of the FDA's current push to have real-world evidence guide more of its decisions.
The partners also will look to characterize the usage and clinical impact of molecular testing with regard to solid tumors and hematological malignancies as they seek to understand outcomes and adverse events related to precision cancer treatments. Syapse will engage oncologists from its own Learning Health Network — a data-sharing network for precision oncology — in joint outcomes research.
"Advances in real-world evidence present an opportunity to learn from patients and potentially translate those insights into safer and more effective therapies," Sean Khozin, associate director for oncology regulatory science and informatics in the FDA’s Oncology Center of Excellence, said in a statement.
"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. 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," Khozin continued.
"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 [real-world evidence] in regulatory decision-making. 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," added Syapse Founder and President Jonathan Hirsch