TSD statistical model - with multiple sites [Two-Stage / GS Designs]

posted by d_stat – Slovenia, 2021-10-11 19:48 (952 d 17:31 ago) – Posting: # 22624
Views: 1,830

Hi Helmut

Thank you for sharing this additional information and insight into Maurer's method.

❝ Perhaps I’m guilty that the FDA asked you for simulations. Backstory: Originally we wanted to go with a variant of ‘Method C’ cause it’s slightly more powerful (esp. when you expect to stop in the IA with BE) and it is preferred by the FDA.

Thus, we are sticking to Potvin. In order to do the validations for multiple-site nature of the study we are thinking of amending the code in the Power2Stage, since it's not part of package yet. Am I wrong to assume the amendment will be connected to decreasing of df for the error term with the number planned sites, or is there any other part that I am missing?
Of course, the alternative is always to encourage (pray to) the holy trinity to update the package ;-)

❝ Our problem (loss of power, increased producer’s risk). Reply: ‘A washout of less then 5times t½ in any of the patients is not acceptable. Use a parallel design.’ Roughly 200 patients / arm. My client is still trying to recover from this shock.

I can image the pain, since I understand the effort to execute such study.

Best Regards, d_stat

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