Hello everybody!
Could you please help me with calculations and script?
The main endpoint analysed using proportion difference.
I have the following information:
1. alpha = 0.05 one-sided;
2. power = 0.80;
3. a non-inferiority margin equal -0.20 (greater is better);
4. an actual difference between treatment groups (test drug - reference drug) planned as -0.05
5. groups weight is 1:1;
6. an overall response rate of reference drug is 38% from articles.
7. stopping rules O’Brien-Fleming ;
8. number of stages is 2:
1 interim at 75% of patients
1 final
I have a draft skript:
proc seqdesign altref=<...>
pss
stopprob
errspend
;
OneSidedOBrienFleming: design
nstages = 2
method = obf
alpha = <...>
beta = 0.20
info = cum(0.75 1);
samplesize model=twosamplefreq (TEST=PROP <...> );
run;
Could You please help to impliment the correct data instead of <...>
Thanks!
Andrey
Dear andrey,
i have the same problem with a margin equal to -0.04 and 0 for actual difference between treatement.
Did you find a solution to your problem ?
Thinks
Damir
As I know, SEQDESIGN does not currently have options to directly support group sequential non-inferiority, superiority, or equivalence trials.
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