The partnership will leverage real-world evidence to improve treatments and breast cancer outcomes.
Photo/Thumb have been modified. Courtesy of Caroline Davis2010 via flickr.
Precision medicine tech company Cota announced today it signed a two-year research collaboration agreement with the U.S. Food and Drug Administration (FDA) Information Exchange and Data Transformation Program — the agency’s data science and technology incubator that supports regulatory science research — to establish a study protocol with an initial focus on breast cancer.
“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,” said Andrew C. von Eschenbach, M.D., president of Samaritan Health Initiatives and former commissioner of the FDA.
The research collaboration agreement will provide the FDA with information on the evolving treatment landscape, including insight on treatment variation within the subpopulation of patients with the disease. The research could expand to other cancer types and explore disease characteristics, treatment patterns and patient outcomes for the broader application of precision medicine.
“This pilot project has the potential to contribute to the foundation for the FDA’s response to the 21st Century Cures (Act) legislation’s mandate to incorporate real-world evidence into a modern regulatory decision processes that accelerate the benefits of precision medicine,” von Eschenbach said.
The agreement could support the FDA’s goal to understand the broader treatment of cancer through the application of real-world evidence.
Mike Doyle, CEO of Cota, told Inside Digital Health™ that the clinical research is entering a new period of discovery combining real-world data and evidence. Doyle said that researchers are committed to putting the patient first and enhancing protocols.
“I think this is the beginning of a whole new era in drug discovery and research using data,” he said. “I can imagine 10 years from now that we look back at a period in which the FDA is embracing new approaches to aid in the discovery of drugs that are going to help patients.”
He said that access to data is incredibly important, along with scrubbing and categorizing them to make sure they are research-grade.
The real-world evidence generated will be enriched using the Cota Nodal Address patient classification system, which could allow for a better understanding of the variance of treatment and outcomes.
Doyle said that the system allows researchers to create cohorts of patients that have similar genotypical and phenotypical characteristics, which is important for clinical trials.
“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 (real-world evidence) and improving the lives of cancer patients everywhere,” Doyle said in today’s announcement.
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