COTA, FDA Partner to Better Understand How to Tailor Cancer Treatments in the Real World

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The FDA is partnering with COTA, a precision medicine technology company, to gain better insight into treatment variation within subpopulations of patients using real-world data. The program will start with breast cancer and may expand to other cancer types.

With only 3% to 5% of patients with cancer enrolled in clinical trials, the FDA is trying to increase patient accrual so trial results better represent treatment effects in the real world. In March, the FDA published 4 draft guidances and 1 final guidance to assist in these efforts. Now, it is partnering with a precision medicine technology company.

FDA Information Exchange and Data Transformation (INFORMED) Program has signed a 2-year Research Collaboration Agreement (RCA) with COTA, Inc. The program will start with breast cancer and aim to establish a study protocol using information on the evolving treatment landscape, such as insight into treatment variation within subpopulations of patients.

"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."


In January, research in JAMA Oncology highlighted the challenge with exclusion criteria and found that patients with comorbidities are less likely to have clinical trial discussions with physicians, have trials offered to them, and participate in them. However, data from the National Cancer Institute, the CDC, and the North American Association of Central Cancer Registries has shown that 30.5% of patients with prostate cancer, 32.2% with breast cancer, 40.7% with colorectal cancer, and 52.9% with lung cancer have comorbidities.1

The partnership between FDA and COTA will provide a real-world observational database for an improved understanding of treatment and outcome differences among the general population of patients with breast cancer.

As the project advances, it may expand to other cancer types. The evidence generated with be enriched with COTA’s patient classification system to better understand variance of patient treatment and outcomes.

"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, chief executive officer 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."


Edwards BK, Noone AM, Mariotto AB, et al. Annual report to the nation on the status of cancer, 1975-2010, featuring prevalence of comorbidity and impact on survival among persons with lung, colorectal, breast, or prostate cancer. Cancer. 2014;120(9):1290-314. doi: 10.1002/cncr.28509.