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COTA Extends Research Collaboration Agreement With the U.S. FDA

Renewed Collaboration Aims to Study the Effects of COVID-19 on Cancer Patients Using Real-World Data

COTA, Inc., a healthcare technology company that uses real-world data to bring clarity to cancer care, announced it has extended its Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA) for an additional three years. This renewed RCA will expand on the objective to explore the applications of real-world data in oncology, including the impact of COVID-19 and the pandemic on cancer treatment. As the project advances, the research will broaden to study other oncology care delivery questions.

With over 8 million cases of COVID-19 in the United States, there is a significant need to understand the pandemic’s impact on oncology care. Additionally, an increasing body of research has shown that oncology patients may be particularly susceptible to harm during this pandemic – both in contracting the condition itself or experiencing care delays.

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Real-world data can provide critical insights into the delivery of cancer treatment in the routine practice setting, as well as potential long-term effects post-COVID-19 recovery. The expanded focus of this RCA will enable the exploration of important research questions to help support FDA’s understanding of how the COVID-19 pandemic continues to impact patients with cancer.

“The pandemic has caused significant disruptions in cancer care and real-world data will be a critical tool in measuring its short- and long-term impact on patient outcomes,” said COTA’s Chief Medical Officer, CK Wang, M.D. “We are pleased to be working with the FDA on this important research that will inform the response to this and future public health crises.”

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“It is critical that we continue to learn more about the patient journey post-recovery and better understand if COVID-19 should be considered as a comorbidity, particularly within the context of clinical trial eligibility criteria,” said Michael Doyle, President and CEO of COTA. “Extending this partnership ensures the FDA has reliable, real-time information about how the pandemic has affected cancer patients by applying real-world data to unlock valuable insights.”

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