Group Sequential Monitoring of Clinical Trials in R

*Blog post
2005
Being updated
Early stopping
R software
Author

Steve Simon

Published

December 13, 2005

It is very expensive to purchase software that performs group sequential monitoring of clinical trials (sometimes called interim analysis). Group sequential monitoring is looking at a trial at selected time points during the study to see if you should stop the study early. There are a couple of functions in R that will do simple calculations, and the price, of course, is free.

The HMisc library created by Frank Harrell has a function ldBands that uses the Lan-DeMets method with flexible alpha spending functions.

The seqmon library created by David A. Schoenfeld has a seqmon function that uses the algorithm by Amitage, McPherson and Rowe. An example they cite shows boundaries using the O’Brien Fleming approach.

I will try to document some of the details of these algorithms and test them against some well known examples when I have time.

Further reading:

Earlier versions are here and here.