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The agreement will bring real-world data to cancer treatment development.
COTA Inc, a precision medicine technology company that uses real-world evidence (RWE) to bring clarity to cancer care, has signed an agreement with FDA’s science and technology incubator, Information Exchange and Data Transformation Program (INFORMED). The agreement will bring real-world evidence to the development of breast cancer treatments.
Under the two-year research collaboration agreement, COTA will establish a study protocol with an initial focus on breast cancer, but will have a potential extension to other cancer types’ disease characteristics, treatment plans, and patient outcomes. Throughout the studies, COTA will provide the FDA with information on the evolving treatment landscape, including insight on treat variation within defined subpopulations of patients with breast cancer and other diseases. The aim of the eventual studies is to expand knowledge for the application of precision medicine.
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Breast cancer is the first disease specified to be studied under the agreement, according to a statement, because there were 332,630 new cases of breast cancer that occurred in 2018, but only 3% to 5% of those patients were enrolled in traditional clinical studies. RWE provided by COTA is expected to allow for deeper insights and greater understanding of the variance of patient treatment outcomes, which will influence treatment plan developments and the development of pharmaceutical products in the future.