Facilitating review of real world data studies: the oncology QCARD initiative

FDA

27 June 2023 - Expanding ways to generate evidence can lead to an array of benefits for medical product development, including more diverse patient representation and the potential to expedite the availability of safe and effective therapies. 

As data sources outside of traditional clinical trials become more accessible and methods for analysing such sources become more robust, there are further opportunities to use real world data to evaluate safety and support evidence of effectiveness.

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Michael Wonder

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Michael Wonder