placeboNonResponder: Example of helper function for determining placebo...

In SPCDAnalyze: Design and Analyze Studies using the Sequential Parallel Comparison Design

Description

The input to SPCDcontinuous requires a logical field which says that the patient was not a placebo responder in the the first phase of the study. Usually this is determined by whether their outcome was greater than a specified value but could have other criteria. This an example program which specifies non-responders as patients whose first phase results were greater than a constant.

Usage

placeboNonResponder(data, ID = "ID", k = 0)

Arguments

data	The data file to use to determine non-response.
ID	Text field indicating the name of the Patient ID variable.
k	A numeric constant. A patient is a non-responder if their change from baseline was greater than k.

Value

A new data frame with a variable named nonResponder.

Note

The choice of criteria should be specified in the protocol. One suggesting is to consider a non responder to be a patient who would still be eligible for the study.

Author(s)

David A. Schoenfeld, [e-mail]

References

Chen, Y. F., Yang, Y., Hung, H. J., & Wang, S. J. (2011). Evaluation of performance of some enrichment designs dealing with high placebo response in psychiatric clinical trials. Contemporary clinical trials, 32,4, 592-604.

Examples

data1=createTestData(times=0:11,n=c(50,50,50),transition=5,rx1=0,rx2=0)
data1=placeboNonResponder(data1,k=0)

SPCDAnalyze documentation built on May 2, 2019, 4 p.m.