Bioequivalence and Bioavailability Forum • EMA: Two-Stage Sequential Designs

EMA: Two-Stage Sequential Designs [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2010-06-15 18:23 (5062 d 09:54 ago) – Posting: # 5522
Views: 14,335

Dear D. Labes!

❝ I have heard some rumor that the Potvin design C may not accepted by the EMA.

❝ Especially the unpenalized stop (without alpha spending) in the first stage if power was demonstrated >80%.

❝ Any comments from the participants of the EGA meeting (aka Klagemauer)?

Hhm, my ears were full of the screams of the desperate there and then.

Only my personal experience with two studies so far. Both protocols were approved by IECs in Berlin and without any questions concerning the method by the BfArM. I specified the method in great detail (including a graphical presentation of the decision tree) and made clear that the patient’s risk is preserved.
My interpretation of the GL calls for an α-correction only if two stages are performed and data pooled.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:

Two-Stage Sequential Designs Helmut 2010-05-20 16:53 [Two-Stage / GS Designs]
- Two-Stage Sequential Designs yjlee168 2010-05-20 21:28
  - Two-Stage Sequential Designs Helmut 2010-05-21 01:06
    - EMA: Two-Stage Sequential Designs d_labes 2010-06-15 16:02
      - EMA: Two-Stage Sequential DesignsHelmut 2010-06-15 16:23
        
        EMA: Two-Stage Sequential Designs The Outlaw Torn 2011-10-20 10:30
        
        EMA: Two-Stage Sequential Designs Helmut 2011-10-21 15:01
        
        PAR? ElMaestro 2011-10-21 15:23
        
        PAR not yet Helmut 2011-10-21 16:02
        
        PAR not yet The Outlaw Torn 2011-10-25 08:57
        
        PAR not yet The Outlaw Torn 2011-10-27 11:07
        
        Potvin C not acceptable! d_labes 2011-10-27 13:16
        PAR not yet ElMaestro 2011-10-27 13:25
        
        PAR not yet The Outlaw Torn 2011-10-31 07:45
        
        No (?) comment :-( Helmut 2011-10-31 15:04