COTA, Inc., a leading precision medicine technology company, has signed a 2-year Research Collaboration Agreement (RCA) with the FDA’s Information Exchange and Data Transformation (INFORMED) program. The agreement establishes a study protocol for research into disparities in treatment and outcomes for patients with breast cancer.
Only 3% to 5% of adults with cancer are enrolled in traditional clinical trials, COTA said in a news release. The FDA hopes this agreement will improve the agency’s understanding of the larger breast cancer landscape through the analysis of real-world evidence (RWE) collected under the INFORMED program. INFORMED is the agency’s data science and technology incubator and supports regulatory science research.
“Traditional clinical trials typically have very strict eligibility criteria and don't always reflect the range of characteristics of patients in the real world," Sean Khozin, MD, MPH, director of the INFORMED program, said in a statement. “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.”
COTA prides itself on using “real-world evidence to bring clarity to cancer care.” The company will employ its Nodal Address patient classification system to “enrich” RWE collected in the study to better understand disparities in treatment and outcomes.
“As the oncology and precision medicine landscape continues to 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,” COTA CEO Mike Doyle, said in a news release. “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.”
Physicians diagnosed more than 332,630 new cases of breast cancer in 2018, creating an urgent need for new therapeutic agents. Furthermore, data exploring how such agents affect patients outside of clinical trials is crucial. This agreement helps the FDA build a growing real-world observational database, which will lead to an improved understanding of treatment and outcome disparities among all patients with breast cancer.
While the current protocol focuses on patients with breast cancer, research could expand to include other cancer types in the future. Such studies would explore patient outcomes, treatment patterns, and disease characteristics, with the ultimate goal of informing the application of precision medicine.
In December 2018, the FDA introduced a new strategic framework detailing its plans to apply RWE to improve regulatory decisions. RWE includes information collected in electronic healthcare records, medical claims, product and disease registries, lab tests, and mobile apps. The agency has made it a strategic priority to expand its use of such data.
“Medicine has become a digital science with both clinical and regulatory decisions dependent on data acquisition, aggregation, and analysis,” Andrew C. von Eschenbach, MD, president of Samaritan Health Initiatives, former commissioner of the FDA, and former director of the National Cancer Institute, said in a statement.
“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 RWE into a modern regulatory decision processes that accelerate the benefits of precision medicine,” he added.
The 21st Century Cures Act aims to expedite medical product development and to introduce new medical innovations and advances faster and more efficiently. The law strengthens the FDA’s ability to modify clinical trial designs and clinical outcome assessments.