COTA extends FDA collaboration to enhance cancer research using real-world data

COTA and the FDA will advance cancer research using real-world data (RWD), focusing on regulatory decision-making and improving treatment evaluation and availability.

COTA, Inc., a company founded by oncologists to leverage RWD and technology for cancer care, has announced an extension of its research collaboration with the US FDA’s Oncology Center of Excellence (OCE). This partnership, originally established in 2018, aims to advance the use of RWD in cancer research by exploring the potential strengths and limitations of using real-world evidence (RWE) for regulatory purposes.

The extended five-year collaboration will focus on leveraging RWE to enhance regulatory decision-making. It will support the use of new oncology data sources to further the mission of the OCE Scientific Collaborative, including a comprehensive analysis of therapies and associated diagnostics in real-world settings. Additionally, the partnership will explore modifiable and non-modifiable factors influencing outcomes in real-world practice, providing valuable insights to inform regulatory science objectives.

COTA and the FDA will jointly evaluate RWD study designs and analytical methods to address clinically meaningful research questions related to the care, treatment, and outcomes of cancer patients. This collaborative effort aims to refine the understanding of how RWD can inform regulatory decisions, improving the assessment and accessibility of novel cancer therapies.

Over the years, this collaboration has yielded numerous oncology research studies presented at significant industry events, such as the American Society of Hematology (ASH) and the American Association of Cancer Research (AACR) annual meetings.

“We are excited to continue our work with the FDA to explore the use of real-world data in oncology research and drug development,” said CK Wang, COTA’s Chief Medical Officer. “Collaboration with institutions like the FDA are critical to advancing the speed and accuracy in which new drugs are evaluated and made available to patients.”

COTA provides high-quality oncology data from leading cancer centers and collaborates with life sciences companies, healthcare providers, and payers to ensure appropriate patient care. It has established partnerships with other leading oncology RWD providers, including Aetion and xCures. Learn more about the role of oncology RWD in driving decision-making and improving patient outcomes in our upcoming webinar:

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