Flatiron Health and FDA renew research collaboration to advance the use of real-world evidence in oncology

Flatiron Health and FDA renew research collaboration over five years to explore real-world data study design and analytic methods in oncology.

Flatiron Health has announced it is entering a five-year extension to its real-world data/evidence (RWD/RWE) research collaboration with the US FDA Oncology Center of Excellence (OCE). The focus of the collaboration will be to develop and implement specific research projects to advance the use of RWD and explore the potential strengths and limitations of using RWE for regulatory purposes in priority, clinically meaningful research questions regarding care, treatment, and outcomes of people with cancer.

“Flatiron is honored to continue our collaboration with FDA,” said Javier Jimenez, Chief Medical Officer, Flatiron Health. “Together we will explore the potential strengths and limitations of using real-world evidence through investigations of a broad set of research questions regarding the care and clinical outcomes of patients diagnosed with solid tumors and hematological malignancies.”

Healthtech company Flatiron began its RWD/E collaboration with the FDA in 2016 and their partnership has produced numerous peer-reviewed publications. Their joint work has been integral to the FDA’s development of its recently published final guidance on use of RWD and RWE to support regulatory decision-making.

Under the renewed collaboration, Flatiron will provide FDA access to their datasets, platform and cutting-edge analytics. Flatiron’s real-world datasets will be analyzed to: explore fit for purpose RWD; create real-world study protocols using best pharmacoepidemiology practices; and conduct observational studies. Joint projects will 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.

This latest announcement from Flatiron follows the May 2023 launch of their Integrated RWE Solutions platform that added RWE generation to their in-house repertoire, and their June declaration of a new phase in their global expansion with a step into the UK through an alliance with a major UK hospital.

Flatiron’s goal is to expand the possibilities for point of care solutions in oncology, transforming patients’ real-life experiences into knowledge and creating a more modern, connected oncology ecosystem that enables smarter care for every person with cancer.

---

You may also be interested in:

• Infographic: Milestones in the FDA’s Real-World Evidence activities
• Case studies of FDA recently approved product applications using real-world evidence: an interview with Jie Li, Gerald Dal Pan and John Concato, FDA
• 1st GetReal Institute Annual Conference: Deep dive into Session 4 – Collaborative use of real-world evidence for a better understanding of value in the US