twostage.inference {clinfun}

Inference following a two-stage design for binary response

Description

Calculates the p-value, UMVUE and CI for the data from a study using a two stage design for response.

Usage

twostage.inference(x, r1, n1, n, pu, alpha=0.05)

Arguments

x

number of responses observed at the end of the study

r1

first stage threshold to declare treatment undesirable

n1

first stage sample size

n

total sample size

pu

unacceptable response rate (null hypothesis)

alpha

the confidence level. For consistency with the design use the same value from the design. (default is 0.05)

Value

twostage.inference returns the UMVUE (Jung & Kim, 2004), p-value and CI (Koyama & Chen, 2008). The CI has confidence level 1-2*alpha and the one-sided (1-alpha) interval consistent with the design is obtained by changing the upper confidence limit (UCL) to 1.

References

Jung SH and Kim KM. (2004). On the estimation of the binomial probability in multistage clinical trials. Statistics in Medicine 23, 881-896.

Koyama T and Chen H. (2008). Proper inference from Simon's two-stage designs. Statistics in Medicine 27, 3145-3154.