Clinical Trials 2015 Practical Session 2

Exercise I Normally Distributed Response Data H 0 :  = 0 H a :  =  a > 0 n=? α=0.05 (two-sided) β=0.20  a /  = 0.25

Exercise II Binary (binomial) response data EAST works in a similar way for binary response data, except that you now enter the probability of an event for the control and then either the probability for the treatment group or the difference in probabilities.

Exercise III Survival Data H 0 : HR = 1 H a : HR <1 (new treatment decreases Hazard) n=? Assume median survival in the control arm= 6 months Assume HR=1/2 α=0.05 (two-sided) β=0.20 Accrual rate=30 patients / month

Exercise IV Noninferiority Trial– Binomial Response H 0 : p T – p S >  0 (the new treatment is considered inferior) H A : p T – p S <  0 (the new treatment is considered non-inferior) – α=0.025 (one-sided) – β=0.10 – p S =0.10 (Probability of event in the control group) –  0 =0.06