Bioequivalence and Bioavailability Forum • Full adaptive with futility rule

Full adaptive with futility rule [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2012-12-05 20:56 (4581 d 21:57 ago) – Posting: # 9678
Views: 9,414

Dear Detlew!

❝ Dropping all the Spanish bells and whistles no one is aware of its foundations,

I’m afraid that’s a prerequisite.

❝ but retaining the sample size adaption based on PE and CV and the PE futility rule leads to a modification of Potvin B (with implicit power)…

Interesting scheme!

❝ Other settings of alpha₁, alpha₂ are imaginable.

❝ For instance alpha₁=0 (resulting in CIs at stage 1 -Inf ... +Inf, i.e. BE test always "BE not proven")

Ha-ha! Bioinequivalence not rejected. ;-)

❝ Here some preliminary results of simulations (10E5 sims only)

Looks promising indeed. Too nasty that these types of simulations converge rather slow. 10⁵ give just a hint. See the plot in this post.

❝ BTW: The futility rule "PE outside 0.85...1/0.85~1.18" was used by Charles Bon, 2007 AAPS Annual Meeting. Unfortunately his presentation "Interim and Sequential Analyses" is no longer found…

Time to write an e-mail.

❝ …on the Indernett.

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

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Complete thread:

Another Two-Stage ‘idea’ (lengthy) Helmut 2012-12-01 01:50
- Not a PSRtPH that can be defended ElMaestro 2012-12-01 22:20
  - Full adaptive without α-spending? Helmut 2012-12-02 11:43
    - Full adaptive with futility rule d_labes 2012-12-05 08:38
      - Full adaptive with futility ruleHelmut 2012-12-05 19:56
  - Piece of paper… Helmut 2012-12-03 02:07
    - Piece of paper… ElMaestro 2012-12-03 07:19
      - Piece of paper… Helmut 2012-12-03 13:02