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Are there situations where you see single arm studies (rather than RCT) can be useful, e.g. ethical consideration in diseases where there is no treatment option?
Thank you for an amazing talk. I would like to hear your thoughts on how to determine an adequate number of patients in subgroups, for example demographics like race, age and sex, to ensure generalizability. Q2- What are your thoughts on global trials conducted exclusively outside of the US but submitted to the FDA.
Thank you for the talk! Some disease areas are difficult to recruit into trials. What are your thoughts on using EHR data to flag / screen for potential trial eligible patients even if they are not diagnosed with the specific disease of interest due to misdiagnosis or under diagnosis?
Thanks for having us