Syapse and FDA Extend Collaboration to Advance the Use of Real-World Data (RWD) and Inform Regulatory Science in Oncology

Research collaboration extended to assess fit-for-purpose real-world data and explore the potential of real-world evidence.

2023/12

News Syapse Holder

SAN FRANCISCO, December 5, 2023 –  Syapse®, a leading real-world evidence company dedicated to extinguishing the fear and burden of serious diseases by advancing real-world care, and the FDA Oncology Center of Excellence (OCE) renewed a four-year agreement to collaboratively develop and implement specific research projects to advance the use of real-world data (RWD) and explore the potential strengths and limitations of using real-world evidence (RWE) to inform regulatory objectives. 

This collaboration specifically aims to evaluate RWD study designs and analytic methods, and to develop clinically meaningful research questions regarding care, treatment, and outcomes of patients with cancer. 

“Our early work with the FDA Oncology Center of Excellence evaluated safety and health disparities through the lens of RWD,” said Thomas Brown, MD, Chief Medical Officer at Syapse. “Specifically, we analyzed real-world immune-checkpoint inhibitor-related pneumonitis in lung cancer and were one of the first to respond to assess the impact of Covid-19 on cancer patients during the pandemic. We look forward to building on these early impactful insights and further collaboration to understand the use of therapies and associated diagnoses in real-world practice to generate evidence and inform regulatory science.”

Over the next four years, Syapse is partnering with the FDA Oncology Center of Excellence to:

  • Explore approaches to define and assess fit-for-purpose relevant data on treatment exposure, patient outcomes, and covariates required to answer specific questions of interest;
  • Analyze the Syapse Learning Health Network (LHN) data to explore fit for purpose RWD, create real-world study protocols using best pharmacoepidemiology practices, and conduct observational studies; and
  • Facilitate the use of novel oncology data sources to support the mission of the OCE Scientific Collaborative through evaluation of RWD sources for evidence generation. 

About Syapse
Syapse is a company dedicated to extinguishing the fear and burden of oncology and other serious diseases by advancing real-world care. By marrying clinical expertise with smart technologies, we transform data into evidence—and then into experience—in collaboration with our network of partners, who are committed to improving patients’ lives through community health systems. Together, we connect comprehensive patient insights to our network, to empower our partners in driving real impact and improving access to high-quality care.

Syapse Contact
Jennifer Jurivich
jennifer.jurivich@syapse.com