Application of Adaptive Interim Analysis in Pharmacology

Abstract

A Drug Information Association Workshop on "Statistical Methodology on Non-Clinical and Toxicological Studies" was held March 25-27, 1996. The purpose of this meeting was to discuss the appropriateness of current and new biostatistical methods in this field of drug development. This paper describes the application of adaptive interim analysis in pharmacological studies. Bauer and Kohne ( 1 ) published a two-step approach in the case of unknown a priori information. This approach is now widely used for clinical trails. Here, the advantages of use in some pharmacological studies will be discussed.

On the Efficiency of Interim Analyses Applied to Nonclinical Studies

“…These optimal values are ob-served whatever the N, δ, and percentage of active compounds. These results concerning α 0 merit underlining as the commonly used value is .5 (1,19).…”