Syapse and FDA renew collaboration to advance use of real-world data and evidence in oncology

Syapse announces 4-year extension of collaboration with FDA to explore fit-for-purpose real-world data and real-world evidence study design in oncology regulatory science.

Syapse^®, a real-world evidence (RWE) company dedicated to reducing disease burden by advancing real-world care, has issued a press release announcing a renewed 4-year agreement with the US FDA Oncology Center of Excellence (OCE). The partnership will focus on developing and implementing specific research projects to advance the use of real-world data (RWD) and explore the potential strengths and limitations of using RWE to inform regulatory objectives.

The renewed collaboration specifically aims to explore fit-for-purpose RWD, to evaluate RWD study designs and analytic methods, and to create real-world study protocols, whilst developing clinically meaningful research questions regarding care, treatment, and outcomes of patients with cancer.

Components of the collaboration over the next 4 years include:

• Exploring approaches to define and assess fit-for-purpose relevant data on treatment exposure, patient outcomes, and covariates required to answer specific questions of interest
• Analyzing Syapse’s Learning Health Network (LHN) data to explore fit-for-purpose RWD, create real-world study protocols according to the most appropriate pharmacoepidemiology practices, and undertake observational studies
• Facilitating the use of novel oncology data sources to support the mission of the OCE Scientific Collaborative through evaluation of RWD sources for evidence generation.

“Our early work with FDA OCE evaluated safety and health disparities through the lens of RWD,” said Thomas Brown, MD, Chief Medical Officer at Syapse. “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.”

Through its collaboration with the FDA OCE, Syapse has recently run several RWD studies. This has included exploring RWD to complement clinical trial data in understanding the incidence of treatment-associated pneumonitis in patients with advanced non-small cell lung cancer receiving immune checkpoint inhibitors or chemotherapies¹, and analyzing real-world immune-checkpoint inhibitor-related pneumonitis in lung cancer. Sypase was also amongst the first to study the impact of COVID-19 infection on cancer patients during the pandemic, using RWD from a retrospective observational cohort study to compare the clinical and demographic characteristics of patients with COVID-19 and cancer².