Dear Allstaters
I've to decide for the sample size of a multiarm phase II clinical trial.
The problem is to evaluate 2 new chemoterapy treatments and to choice the best
one for a possible phase III design. The outcome is response.
We know that standard therapy response is p0; response at treatment-1 will be
p1 and p2 for treatment-2.
We'll continue the study on treatment-1 if p1>p2 and p1>p0 (from a statistical
point of view). We'll continue with treatment-2 if p2>p1 and p2>p0. No further
analysis will be performed if p1<=p0 and p2<=p0.
Questions:
- Which is the best criterion to establish the sample size?
- Does anyone knows other works about multiarm phase II design based on
response, apart Simon et al (1985) Randomized Phase II Clinical Trials, Cancer
Treatment Reports, 69, n. 12?
- Which problems arise using standard optimization criterion for 2 stage phase
II clinical trial (Simon, Optimal two-stage design for phase II clinical
trials, Controlled Clinical Trials 10:1-10, 1989), considering the two arms as
two separated studies?
- If you've to choice one, which combination do you prefer between {alpha=0.05
& beta=0.20} and {alpha=0.10 & beta=0.10} in a phase II?
many thanks
Cristian
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Cristian Pattaro
Sezione di Epidemiologia & Statistica Medica
Dipartimento di Medicina e Sanità Pubblica
Università degli Studi di Verona
Istituti Biologici II - Blocco B
Strada Le Grazie, 8
I-37134 Verona - Italy
Tel +39 045 8027668
fax +39 045 505357
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