PAR not yet [Two-Stage / GS Designs]
Hi tOT,
Difficult.
It's their call, really. To distinguish between the methods in practice I think one needs:
Sounds to me like you should use method B if you wish to avoid discussion and if in vivo T/R really is 0.95.
❝ “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.
❝
❝ They go on to suggest method B because "The authors demonstrate by simulations that the power of this method is only slightly lower than for “Method C”, resulting in comparable mean total number of subjects."
❝
❝ Any comments?
Difficult.
It's their call, really. To distinguish between the methods in practice I think one needs:
- To decide which T/R is realistic. 0.95 is a guess but do you have any idea really apart from dissolution?
- You proposed number of subjects in stage 1 (n1).
- Futility vs. power at the given T/R and n1 for the entire range of CVs.
Sounds to me like you should use method B if you wish to avoid discussion and if in vivo T/R really is 0.95.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
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 Designs Helmut 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 yetElMaestro 2011-10-27 13:25
- PAR not yet The Outlaw Torn 2011-10-31 07:45
- No (?) comment :-( Helmut 2011-10-31 15:04
- PAR not yet The Outlaw Torn 2011-10-31 07:45
- PAR not yet The Outlaw Torn 2011-10-27 11:07
- PAR not yet The Outlaw Torn 2011-10-25 08:57
- PAR not yet Helmut 2011-10-21 16:02
- PAR? ElMaestro 2011-10-21 15:23
- EMA: Two-Stage Sequential Designs Helmut 2011-10-21 15:01
- EMA: Two-Stage Sequential Designs The Outlaw Torn 2011-10-20 10:30
- EMA: Two-Stage Sequential Designs Helmut 2010-06-15 16:23
- EMA: Two-Stage Sequential Designs d_labes 2010-06-15 16:02
- Two-Stage Sequential Designs Helmut 2010-05-21 01:06
- Two-Stage Sequential Designs yjlee168 2010-05-20 21:28