RESIST TB WEBINAR - Shared screen with speaker view
Carole Mitnick
Thanks for joining the RESIST-TB webinar. Please be sure to enter your questions into the chat and to make sure your microphone is muted. We'll have a discussion at the end. And, please note that the session is being recorded. Thanks.
Carole Mitnick
please feel free to put questions in the chat
David Holtzman
Thanks Suzanne for a great presentation on this important work. Have you looked at how safety endpoints could also be brought into this decision framework at the 2nd step to complement efficacy as measured by MGIT TTP? For example, using rates of Gd3+ AEs, % of pts with treatment interruptions, etc. When we are looking at novel regimens that have 2+ investigational agents (like UNITE4TB), the safety profile can be less predictable than Ph2b trials using new agents within established classes (eg, rifamycins, FQs). It would be great to bring safety into this framework, if possible.
Gheorghe Doros
Thank you for the presentation. There have been many prior proposals that rely on the existence of surrogate endpoints. They are not used because there are very few reliable surrogate endpoints. You mentioned that TTP might not be a reliable surrogate endpoint. There are some proposed criteria to judge whether an outcome is a surrogate endpoint. Have you studied whether your proposed interim endpoint is a surrogate endpoint?
Great presentation - thank you. Have you evaluated whether the frequentist concept of type 1 error be controlled with this framework?