COTA, Inc., a leading precision medicine technology company that uses real-world evidence to bring clarity to cancer care, today announced it has signed a two-year Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA) Information Exchange and Data Transformation (INFORMED) Program, the Agency’s data science and technology incubator supporting regulatory science research. This RCA 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 explore disease characteristics, treatment patterns, and patient outcomes for the broader application of precision medicine.
As only three to five percent of all adult cancer patients are enrolled in traditional clinical trials, the RCA announced today will support the FDA’s goal to better understand the broader treatment of cancer through the application of real-world evidence (RWE) under the INFORMED Program. The RWE generated through this collaboration will be enriched using the COTA Nodal Address® (CNA) patient classification system, allowing for deeper insights and greater understanding of the variance of patient treatment and outcomes.
“Traditional clinical trials typically have very strict eligibility criteria and don’t always reflect the range of characteristics of patients in the real world,” said Sean Khozin, MD, MPH, Director of the INFORMED Program. “Real-world data provides an opportunity to improve our understanding of the experience of a broader patient population in support of developing tailored treatment decisions at the point of routine care.”
“With breathtaking speed, medicine has become a digital science with both clinical and regulatory decisions dependent on data acquisition, aggregation and analysis. This FDA/COTA collaboration is a transformational public private partnership that will apply the unique new digital tools developed by COTA to a rich depository of real world data on breast cancer. This pilot project has the potential to contribute to the foundation for the FDA’s response to the 21st Century Cures legislation’s mandate to incorporate Real World Evidence (RWE) into a modern regulatory decision processes that accelerate the benefits of precision medicine.” Said Andrew C. von Eschenbach, MD at Samaritan Health Initiatives, former commissioner of the FDA and former director of the National Cancer Institute.
With over 332,630 new cases of breast cancer in 2018, and the approval of new therapies to treat advanced disease, further data is necessary to understand how such drugs impact patients outside of clinical trials. This RCA provides a growing real-world observational database for the FDA, allowing for an improved understanding of treatment and outcome differences among the general population of patients with breast cancer.
“As the oncology and precision medicine landscape continues to rapidly evolve, we are excited to be on the front lines, aiding in developing a strong understanding of the functions of RWE and improving the lives of cancer patients everywhere,” said Mike Doyle, CEO of COTA. “We’re honored to be partnering with the FDA to do our part in improving care for patients and helping to shape regulatory decision making.”