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Application: To test whether there is a difference between the mean response rates of the test drug and the reference drug; the following hypotheses are usually used:
Procedure:
a) value of α, the probability of type I error
b) value of β, the probability of type II error
c)
value of θ1, a true
mean response rate of a test drug
d) value of θ2, the true mean response rates of a control drug
e) value of r, allocation ratio,.
Formula:
(*)
Notations:
α: The
probability of type I error (significance level) is the probability of rejecting the true null
hypothesis.
β: The
probability of type II error (1 – power of the test) is the probability of
failing to reject the false null hypothesis.
θ1-θ2: The difference between the true mean response rates of a group1 (i.e., a test drug (θ1) and group2 (i.e., a control (θ2))).
r: The allocation ratio,. i.e., r=1 for equal allocation.
Examples Top
Example 1:
Suppose that a difference of θ1–θ2=20% in clinical response of cure is
considered of clinically meaningful difference between the two anti-microbial
agents. By (*), assuming that the true rate for the active control agent is 65%
(θ1=0.65 and θ2=0.85), then the required
sample size with equal allocation (r=1)
to achieve an 80% power (β=0.2) at α=0.05 can be determined by.
Reference: