What You Should Know:
The FDA and Syapse announce research collaboration expansion to address urgent public health challenges including supporting FDA’s goal of rapid understanding of COVID-19.
As part of the research, Syapse is partnering with FDA’s Oncology Center of Excellence to investigate methods to derive RWD from multiple sources including electronic health records, registries and molecular data
Syapse, a real-world evidence company accelerating the delivery of precision medicine through the Syapse Learning Health NetworkTM, and the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) have expanded an existing multi-year Research Collaboration Agreement (RCA) focused on the use of real-world data (RWD) to support clinical and regulatory decision-making.
Research Collaboration Details
Through a multi-year collaboration, Syapse is partnering with FDA’s Oncology Center of Excellence to:
– Investigate methods to derive RWD from multiple sources including electronic health records, registries and molecular data;
– Enhance understanding of how patients respond to therapies outside of clinical trials to improve care and outcomes; and
– Understand the impact of COVID-19 on cancer care.
Based on their collaboration efforts, Syapse and the FDA have highlighted results from rapid analyses of real-world data involving cancer patients with COVID-19. Recently, the FDA’s OCE and Syapse presented data at a virtual medical meeting of an analysis of more than 200,000 health records of people living with cancer across two major health systems. Data suggest that patients with cancer who also had COVID-19, compared to those who did not have COVID-19, are more likely to have other health conditions such as kidney failure, obesity and heart disease, in addition to increased rates of hospitalization and invasive mechanical ventilation, along with 16 times greater risk of death. Syapse and its Learning Health Network collaborators presented these findings at the AACR Virtual Meeting on COVID-19 and Cancer on July 22, 2020. The full presentation can be found on the Syapse website.
Thomas Brown, MD, Syapse’s chief medical officer, stated, “Understanding how a patient’s medical history influences their treatment outcomes in a real-world setting is critical for clinicians, researchers and regulatory agencies to appropriately weigh the risk-benefit profile of a drug for a given patient.”
Syapse’s global network of healthcare providers shares real-world data to support clinical decisions and foster collaborations among participants. Healthcare providers, including doctors and nurses, share and learn which cancer treatments produced better real-world outcomes in clinically and molecularly similar patients.