What You Should Know:
– COTA, a leader in real-world data and analytics solutions, today announced a five-year extension of its research collaboration with the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE).
– The five-year extension builds upon a successful partnership established in 2018 and signifies a continued commitment to utilizing real-world data (RWD) to enhance cancer treatment and regulatory decisions.
Building on a Successful Foundation
The initial collaboration, established in 2018, has yielded significant results. Joint research efforts have produced numerous oncology studies presented at prestigious conferences like the American Society of Hematology (ASH) and the American Association of Cancer Research (AACR).
Leveraging RWD for Stronger Regulatory Decisions
The extended collaboration focuses on harnessing the power of RWD to strengthen the FDA’s regulatory decision-making process. Key areas of focus include:
- RWD Study Design and Analysis: COTA and the FDA will collaborate on developing optimal RWD study designs and analytical methods for investigating clinically relevant questions.
- Priority Research Questions: Joint efforts will prioritize research questions that address critical aspects of cancer care, treatment, and patient outcomes.
- New Data Sources: The collaboration will explore the utilization of new oncology data sources to support the OCE Scientific Collaborative’s mission.
- Real-World Use of Therapies: The project will gain a deeper understanding of how therapies and associated diagnostics are used in real-world clinical settings.
- Factors Influencing Outcomes: Researchers will explore modifiable and non-modifiable factors that impact patient outcomes in real-world practice, informing future regulatory science efforts.
“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 C.K. 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.”
