GM ★ India, 2018-07-25 15:52 (2073 d 06:30 ago) Posting: # 19099 Views: 1,900 |
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Hello All, 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, Regards, GM. — Best Regards, GM |