COTA Announces Extended Collaboration with FDA to Advance the Use of Real-World-Data in Cancer Research

NEW YORK--(BUSINESS WIRE)--Today, COTA announced an extension of its research collaboration with ​​the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence. Under the collaboration, the two organizations will continue to jointly develop and implement research projects to advance the use of real-world data (RWD) and explore the potential strengths and limitations of using real-world evidence (RWE) for regulatory purposes.

This collaboration serves as an extension of the agreement between COTA and the FDA established in 2018. To date, the partnership has yielded numerous oncology research studies that have been presented at the annual meetings of the American Society of Hematology (ASH) and the American Association of Cancer Research (AACR).

The collaboration has been extended for an additional 5 years, focusing on leveraging real-world evidence to strengthen regulatory decision-making. COTA and the FDA will evaluate RWD study designs and analytic methods through the collaborative development of priority, clinically meaningful research questions regarding care, treatment, and outcomes of patients with cancer.

“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.”

This collaboration will facilitate the use of new oncology data sources to support the mission of the OCE Scientific Collaborative. Additionally, the collaboration will support a better understanding of the use of therapies and associated diagnostics in real-world settings, along with exploration of the modifiable and non-modifiable factors influencing outcomes in real-world practice to inform regulatory science objectives.

About COTA, Inc.

Founded by oncologists, COTA is committed to creating a precise, patient-first approach to cancer care through the use of real-world data. The company leverages technology-supported data abstraction methods to make sense of complex, fragmented patient data from the real world. Offering the highest quality oncology real-world data from leading academic and community-based cancer centers and an advanced analytics platform, COTA partners with leading life sciences companies, providers, and payers to ensure that everyone touched by cancer has a clear path to the right care. To learn more about COTA and how to fast-track improvements in cancer care and treatment with comprehensive and diverse real-world data and analytics, visit cotahealthcare.com.