Flatiron Health today announced its renewed collaboration with the Oncology Center of Excellence (OCE) of the United States Food and Drug Administration (FDA) to jointly 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) for regulatory purposes. The partnership will specifically evaluate RWD study designs and analytic methods through the collaborative development of priority, clinically meaningful research questions regarding care, treatment, and outcomes of patients 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.”
Further, projects under this collaboration 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. As part of the research process, Flatiron’s datasets will be analyzed to explore fit for purpose RWD, create real-world study protocols using best pharmacoepidemiology practices, and conduct observational studies. Additionally, the collaboration will enable Flatiron to provide FDA access to their datasets/platform, and highlight their suite of services, including cutting-edge analytics, scientific expertise, and strategic consulting.
About Flatiron Health
Flatiron Health is a healthtech company expanding the possibilities for point of care solutions in oncology and using data for good to power smarter care for every person with cancer. Through machine learning and AI, real-world evidence, and breakthroughs in clinical trials, we continue to transform patients’ real-life experiences into knowledge and create a more modern, connected oncology ecosystem. Flatiron Health is an independent affiliate of the Roche Group.
