COTA, Inc, a precision medicine technology company, announced that it has signed a 2-year Research Collaboration Agreement with the U.S. Food and Drug Administration (FDA) Information Exchange and Data Transformation (INFORMED) Program, the Agency’s data science and technology incubator that supports regulatory science research. This collaboration will establish a study protocol with an initial focus on breast cancer and will provide the FDA with information on the evolving treatment landscape, including insight on treatment variation within defined subpopulations of patients with the disease. As the project advances, the research may expand to other cancer types and may explore disease characteristics, treatment patterns, and patient outcomes for the broader application of precision medicine.
As just between 3% and 5% of all adult patients with cancer are enrolled in traditional clinical trials, the collaboration announced that it will support the FDA’s goal to better understand the broader treatment of cancer through the application of -real-world evidence under the INFORMED Program. The real-world data generated through this collaboration will be enriched using the COTA Nodal Address® patient classification system, allowing for deeper insights and greater understanding of the variance of patient treatment and outcomes. ■