Appropriate wording for a protocol [Two-Stage / GS Designs]

posted by Elena777 – Belarus, 2019-09-09 19:34  – Posting: # 20564
Views: 4,455

Dear all, I would be pleased to get your opinion on the following. We are planning to conduct several BE studies with adaptive design using the drugs with uncertain intraCV. We have decided to use method C described by Potvin and included the description of the model C in the protocols (the same as in the corresponding scheme presented in Potvin's article). But it seems it's not enough.
  1. Should we include the information that evaluation after stage 1 completion should be performed assuming GMR=0.95?
  2. Should we describe the maximum number of subjects who can be included in whole or in stage 2?
  3. Any other information that should be clearly stated in order to be accurate and to satisfy regulatory authorities?
  4. What if BE criteria are met after stage 1, but estimated power is too low (e.g. 30%)?


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