What You Should Know:
– The FDA just extended its research collaboration
agreement (RCA) with COTA, specifically looking at how COVID-19 is affecting
– With this expanded agreement, COTA and the FDA will use real-world data to explore the impact of COVID-19 and the pandemic on cancer treatment, with the opportunity to expand into other oncology questions in the future.
COTA, Inc., a healthcare technology
company that uses real-world data to bring clarity to cancer care, today
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.
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
Why It Matters
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.
Cancer patients are particularly at risk of severe complications with COVID-19, and there is currently no understanding of how this can affect their oncology care or progression. Through real-world data, we can begin to understand if COVID-19 should be considered as comorbidity – particularly around clinical trial criteria.