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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.

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?