Still SF [Two-Stage / GS Designs]
Hello VStus,
Yes
Nitpicking: you perform a 2-stage trial or a pilot trial because you do not know the variability, right? Which means the "let's say 50% power" in actuality means guessworking. Optimizing the formulation on basis of a pilot trial with inherently low power (=high uncertainty on the PE) is in scientific terms as solid as tarot cards or crystal healing.
I read on LinkedIn the other day: "The flat earth society has members all over the globe"


OK, surely I will get in trouble for this post.

❝ But back to reality: isn't it more practical in case of HVD to perform pilot on development with let's say 50% power (wondering: replicated pilot to keep reasonable small population?), better understand in-vitro in-vivo relationship, optimize formulation and than run replicate scaled trial? In 2-stage we also need to wait for results from the 1st stage...
Yes
Nitpicking: you perform a 2-stage trial or a pilot trial because you do not know the variability, right? Which means the "let's say 50% power" in actuality means guessworking. Optimizing the formulation on basis of a pilot trial with inherently low power (=high uncertainty on the PE) is in scientific terms as solid as tarot cards or crystal healing.
I read on LinkedIn the other day: "The flat earth society has members all over the globe"



OK, surely I will get in trouble for this post.

—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Replicated 4×2 and two-stage-design, in the same protocol Mauricio Sampaio 2015-04-06 08:37 [Two-Stage / GS Designs]
- Replicated 4×2 and two-stage-design, in the same protocol ElMaestro 2015-04-06 08:53
- Science fiction Helmut 2015-04-06 14:20
- Science fiction Dr_Dan 2016-03-04 10:33
- mindblowing ElMaestro 2016-10-11 07:44
- Natural constant as usual; not for reference-scaling Helmut 2016-10-11 09:50
- Consistency DavidManteigas 2016-10-11 11:25
- Natural constant as usual; not for reference-scaling Helmut 2016-10-11 09:50