15 October 2019 - The US FDA has been working with several different data and research companies to further its understanding of how real-world data (RWD) and real-world evidence (RWE) can help to inform its regulatory decision making.

One such company that has signed an RWE research collaboration with FDA is COTA, Inc., which is working on a project related to replicating a breast cancer study.

Andrew Norden, chief medical officer of COTA, told Focus in a phone interview that breast cancer is an area where RWE can prove valuable, as breast cancer clinical trials can take a long time to complete and as endpoints like survival or even progression can also take a significant amount of time to read out.

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