Posting: # 19099
I have very limited knowledge on Sample size calculation for Clinical Endpoint study.
I was serched for the same in this forum. Bt I didn't get clear idea on calculation of sample size.
I have the blow information to calculate Sample size.
Study Title: "RANDOMIZED, PLACEBO CONTROLLED, PARALLEL-GROUP STUDY, COMPARING TEST Vs. RLD"
RLD appears to produce a percent reduction for IL that could be as low as 55.8% and vehicle %reduction can be as high as 41.5% after 12 weeks of treatment.
For NIL, the %reduction for RLD appears to be approximately 43.5% with vehicle producing as high as 27.9% reduction.
The anticipated standard deviation for IL and NIL is 36% for active treatment and 45% for vehicle treatment.
The sample size should sufficient to show superiority b/w Test, RLD Vs. Vehicle and equivalence b/w Test Vs. RLD.
My doubt is, whether we need to calculate seperate sample size for superiority and equivalence or at the same time.
Any SAS code or R code availabe for the same. Kindly suggest something on this.
Thanks in advance,