design.tournoux: Tournoux 2-stage Phase II design

In ph2hetero: Stratified Adaptive Designs for Two-Stage Phase II Studies

Description

Calculates Optimal 2-stage Phase II designs given by Caroline Tournoux-Facon (2011).

Usage

  design.tournoux(alpha=0.05,beta=0.2,p0n,p0p,p1n,p1p,w=1,gamma=0.6)

Arguments

alpha	Type I error.
beta	Type II error.
p0n	Max unacceptable response rate for "negative" subgroup.
p0p	Max unacceptable response rate for "positive" subgroup.
p1n	Min acceptable response rate for "negative" subgroup.
p1p	Min acceptable response rate for "positive" subgroup.
w	Ratio between the two subgroups \frac{N_{pos}}{N_{neg}}.
gamma	Level of the heterogeneity test.

Value

Returns a data.frame object which components are number of patients, error-rates and power-levels for each stage. The first line of the data.frame corresponds to the arguments for an One-stage Fleming design and the others are two-stages Fleming designs with :

- Non-stratified heterogeneous Fleming two-stage design when psi=0.

- Stratified adaptive Fleming two-stage with identification of heterogeneity of responses in favour of "negative" subgroup when psi=1.

- Stratified adaptive Fleming two-stage with identification of heterogeneity of responses in favour of "positive" subgroup when psi=2.

Author(s)

Patrick Sfumato and Bastien Cabarrou.

References

Tournoux-Facon C, De Rycke Y and Tubert-Bitter P (2011).Targeting population entering phase III trials: A new stratified adaptive phase II design. Statistics in Medecine 30(8) 801-11.

Tournoux-Facon C, De Rycke Y and Tubert-Bitter P (2011).How a new stratified adaptive phase II design could improve targeting population. Statistics in Medecine 30(13) 1555-62.

Examples

out.tournoux<-design.tournoux(p0n=0.15,
                              p0p=0.15,
                              p1n=0.30,
                              p1p=0.25,
                              w=2,
                              gamma=0.6,
                              alpha=0.05,
                              beta=0.1)

ph2hetero documentation built on May 2, 2019, 4:13 a.m.