Medical technology company COTA has signed a two-year research collaboration agreement (RCA ) with the US food and drug administration (FDA) Information Exchange and Data Transformation (INFORMED) programme.
INFORMED programme is the US FDA’s data science and technology incubator that supports regulatory science research.
The research collaboration agreement will establish a study protocol, with its initial research on patients with breast cancer.
It will provide the agency with information on the treatment landscape, including insight on the variation of treatment, within limited subpopulations of patients suffering with breast cancer.
Due to the least enrollment of adult cancer patients in traditional clinical trials, the RCA announced to support the FDA’s goal to understand the broader treatment of cancer through real-world evidence (RWE ) application, under the INFORMED programme.
The collaboration aims to study variation in the cancer treatment patterns by extracting and analysing real-world data.
INFORMED programme managing director Sean Khozin said: “Traditional clinical trials typically have very strict eligibility criteria and don’t always reflect the range of characteristics of patients in the real world.”
FDA former commissioner and National cancer Institute former director Andrew C. von Eschenbach said: “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.”
COTA CEO Mike Doyle said: “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.”