AnIItoIIIRe: Use of Phase II estimates to plan Phase III sample size.

In arsenionhacolo/InferenceBEAGSD: Inference for Binary Endpoint Adaptive Group-Sequential Designs

Description

AnIItoIIIRe calculates the power in a Phase III equal-size group two-arm randomized clinical trial with a binary response planned using estimates from Phase II adaptive two-stage trial.

Usage

AnIItoIIIRe(rslt, f = c(0.95, 0.96, 0.97, 0.98, 0.99))

Arguments

rslt	Dataframe containing the output from the function AnalyzeEKOAD, but with only successful trials (rslt$suco==1), i.e., trials in which H_0 was rejected.
f	Vector of length 5 containing multiplicative ajustment factors to be applied to Phase II estimates. The default is f = c(.95,.96,.97,.98,.99).

Details

The sample size (N) of the Phase III trial is based on the estimates naive MLE and estimators proposed by Nhacolo and Brannath (2018). Different values of retention factor f proposed by Kirby et al. (2012) are applied.The control group response rate is considered to be equal to that under the null hypothesis of the Phase II design, and the hypothesized treatment group response rate considered to be equal to that estimated from the Phase II trial. The target type I error and power are the same as of the Phase II design.Two-sided hypothesis test is assumed.N is a sample size per group, and equal size groups are assume. Hence, N total is 2*N. When calculating the power, the true response rate (in treatment group) is considered to be the one under which the Phase II trial was simulated (spi1).

Value

The input dataframe with corresponding Phase III sample size and power.

Author(s)

Arsenio Nhacolo

References

Nhacolo, A. and Brannath, W. Using Estimates from Adaptive Phase II Oncology Trials to Plan Phase III Trials. In press.

Nhacolo, A. and Brannath, W. Interval and point estimation in adaptive Phase II trials with binary endpoint. Stat Methods Med Res, 2018.

Ahn, C., Heo, M. and Zhang, S. Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research. CRC Press, 2014.

See Also

AnalyzeEKOAD, SimulateEKOAD, PerforIItoIIIRe.

arsenionhacolo/InferenceBEAGSD documentation built on May 9, 2019, 4:10 a.m.