Potvin C not acceptable! [Two-Stage / GS Designs]

posted by d_labes  – Berlin, Germany, 2011-10-27 15:16 (5354 d 11:47 ago) – Posting: # 7553
Views: 18,250

Dear Outlaw!

❝ We provided our protocol to a central European country and this is what they responded about Potvin method C:


“Method C” as proposed in this publication is not acceptable, as type I error is not controlled on the 5% level and alternative methods securing type I error control are available.


Regulators are a strange bunch :-D.
Seems they (whoever that is) have taken the 5% literally and do not accept the empirical overall alpha values in method C which are slightly above 5% around CV = 10 to 20%.
Potvin et al. have pointed out clearly that the excess is not at least due to the simulation methodology and may vanish if the number of simulated studies will be raised. Therefore the authors have decided to take only alpha inflation greater then 5.2% as serious (real).
Seems they have not read this or are "päpstlicher als der Pabst" (They are more Catholic than the pope).

Seems this compared to Helmut's experience is a case of ElMaestros "variable constants" :cool:.

Regards,

Detlew

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
128 visitors (0 registered, 128 guests [including 29 identified bots]).
Forum time: 03:03 CEST (Europe/Vienna)

The great tragedy of Science – the slaying
of a beautiful hypothesis by an ugly fact.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5