Bioequivalence and Bioavailability Forum

Bad weather? [Two-Stage / GS Designs]

posted by Helmut  – Vienna, Austria, 2018-06-13 21:23 (2510 d 14:33 ago) – Posting: # 18901
Views: 17,253

Dear Detlew,

❝ If I see it correctly…

You do.

❝ … that's called in Maurer et al. "futility rule can be applied in a nonbinding manner, ie, it can be used as guidance but must not necessarily be followed." (page 19, bottom)

Sounds to me like the statement of the FDA’s guidances “Contains Nonbinding Recommendations” or a similar one in the protocols of European Scientific Advices. 

❝ How to obtain a sample size number for the second stage if we want to do so?

Introducing fuzzy logic to the AlGore Rhythm? Stop if it looks really terrible or continue if the weather is not that bad.*

---

• Questions to the brave Irishman:
  “How are you doing?” – “Not that bad…”
  “How is the weather in Ireland?” – “It doesn’t rain all the time.”

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


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

• Finally: Exact TSD methods for 2×2 crossover designs Helmut 2018-04-21 17:17 [Two-Stage / GS Designs] 
  • Exact TSD methods: Example Helmut 2018-04-21 20:33
  • Finally: Exact TSD methods for 2×2 crossover designs ElMaestro 2018-04-21 20:49
    • Flow chart (without details) Helmut 2018-04-21 21:41
      • naive questions regarding new functions in Power2Stage mittyri 2018-04-28 15:54
        • Some answers Helmut 2018-04-28 17:29
        • Some more "answers" d_labes 2018-04-29 21:11
          • clarification regarding user Power2Stage guides mittyri 2018-04-30 13:41
  • Technicality: Weigths for the inverse normal approach d_labes 2018-04-25 14:19
    • Selection of w and w* Helmut 2018-04-26 09:51
      • Selection of w and w* d_labes 2018-04-26 20:02
      • Now what? w & w* examples d_labes 2018-05-09 13:53
        • Now what? w & w* examples Ben 2018-06-10 20:12
          • Now what? w & w* examples Helmut 2018-06-11 13:57
            • Now what? w & w* examples Ben 2018-06-12 19:14
          • a bug in interim.tsd.in()? mittyri 2018-06-11 23:27
            • a bug in interim.tsd.in()? Ben 2018-06-12 19:32
              • Nonbinding futility rule d_labes 2018-06-13 16:59
                • Bad weather?Helmut 2018-06-13 19:23
                  • NLYW? d_labes 2018-06-14 10:18
                • Nonbinding futility rule Ben 2018-06-13 20:26
                  • Nonbinding futility rule d_labes 2018-06-14 10:47
                    • Nonbinding futility rule Ben 2018-06-15 17:58
                      • Binding / Nonbinding futility rule - alpha control d_labes 2018-06-16 19:42
                        • Binding / Nonbinding futility rule - alpha control Ben 2019-03-30 09:52