Bioequivalence and Bioavailability Forum • Sequential trial with B method of Potvin

Sequential trial with B method of Potvin [Two-Stage / GS Designs]

posted by ElMaestro – Denmark, 2015-10-01 19:58 (3453 d 12:12 ago) – Posting: # 15514
Views: 11,676

Hi JJ,

❝ In a sequential clinical trial conducted like a B method of Potvin, we have Cmax and AUC both not bioequivalent. Cmax has a power <80% (71.5%), and AUC>80% (84.6%).

❝ AUC 0-30min calculated by protocol is bioequivalent.

❝ In the protocol it was not specified how to proceed in this situation.

❝

❝ Can we calculate a new n and pass to the second phase? Or we must stop the trial?

I would go by the metric that displays the highest variance, which is usually Cmax. I suggest to proceed towards stage 2 on that basis.
However, since this was not pre-specified it is your protocol that document may be your biggest issue now; regulators may not like whatever decision you take.

—
Pass or fail!
ElMaestro

Complete thread:

Sequential trial with B method of Potvin john john 2015-10-01 17:44 [Two-Stage / GS Designs]
- Sequential trial with B method of PotvinElMaestro 2015-10-01 17:58
- Sequential trial with B method of Potvin Helmut 2015-10-01 18:13
  - Sequential trial with B method of Potvin john john 2015-10-07 11:26
    - Power to the people d_labes 2015-10-07 13:49
      - Power to the people john john 2015-10-07 14:54
        
        Software? Ethics beyond statistics… Helmut 2015-10-07 16:06
        
        Subtraction of a df ElMaestro 2015-10-07 21:22
        
        df = df-1 d_labes 2015-10-08 08:10
    - Potvin B: α 0.0294 in both stages Helmut 2015-10-08 15:27
      - Potvin B: α 0.0294 in both stages john john 2015-10-23 12:04