Name: Shen

Firstname: Liji

Title: Statistical Leader

Institution: Sanofi-synthelabo Research

Street: 9 Great Valley Parkway

City: Malvern

Zip-Code: 19355

Country: USA

Phone: 610 889-8439

Fax: 610 889-6932


Authors: Liji Shen

Title: A new method to evaluate drug effect in a multiple dose clinical trial

Abstract: Stepwise Over-Correction (SOC) is a new method to evaluate drug effect in a multiple dose clinical trial. The author found that the difficulties of statistical inference in multiple-dose trials was caused by improper statistical estimates for the parameter in the tests. For example, the maximum observed response rate will overestimate the response rate of the selected dose. The new method (SOC) was proposed to correct the bias due to the overestimation. Simulations show that SOC is better than methods such as Bonferroni's procedure. This new method is particularly useful in a two-stage phase II/III design which contains a dose finding stage and a confirmatory stage.

References: 1. Thall PF, Simon R, Ellenberg S. A two-stage design for choosing among several experimental treatments and a control in clinical trials. Biometrics 1989; 45:537-547. 2. Sankoh AJ, Huque MF, Dubey SD. Some comments on frequently used multiple endpoint adjustment methods in clinical trials. Statistics in Medicine 1997;16:2529-2542. 3. Shen L. An improved method of evaluating drug effect in a multiple dose clinical trial. Statistics in Medicine 2001;20:1913-1929