Name: Wassmer

Firstname: Gernot

Title: Dr.

Institution: IMSIE University Cologne

Street: Joseph-Stelzmann-Str 9.

City: Koeln

Zip-Code: 50931

Country: Germany

Phone: +492214786512

Fax: +492214786520

Email: gernot.wassmer@medizin.uni-koeln.de

Authors: Wassmer, G. and Eisebitt, R.

Title: ADDPLAN 2002: A Software for Planning and Analysing an Adaptive Design (Software Demonstration)

Abstract: A flexible adaptive design is based on combining the p-values obtained from the separate stages by use of the inverse normal method. This strategy keeps the Type I error rate. It was proposed for two-stage designs by Bauer and Koehne (1994) and more generally for multistage designs by Lehmacher and Wassmer (1999). The resulting design is a powerful extension to the classical group sequential test designs. ADDPLAN 2002 is designed for the purpose of planning and conducting a clinical trial based on an adaptive group sequential test design using the combination test principle. In order to evaluate the performance of an adaptive design one can also simulate a specific adaptation rule. ADDPLAN 2002 incorporates the key features of planning and conducting a sequentially planned clinical trial within a user-friendly interface.

References: Bauer, P., K{\"o}hne, K. (1994). Evaluation of experiments with adaptive interim analyses. {\em Biometrics\/} {\bf 50}: 1029--1041.

Lehmacher, W., Wassmer, G. (1999). Adaptive sample size calculations in group sequential trials. {\em Biometrics\/} {\bf 55}: 1286--1290.

Wassmer, G., Eisebitt, R., Coburger, S. (2001). Flexible interim analyses in clinical trials using multistage adaptive test designs. {\em Drug Inf. J.\/} {\bf 35}: 1131--1146.