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Discovery Lecture - Dr. DeMets - Shared screen with speaker view
Alan
01:06:15
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?
Laura.Fernandes@fda.hhs.gov
01:09:33
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.
Victoria Gamerman
01:17:50
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?
Lei.Nie@fda.hhs.gov
01:24:41
Thanks for having us