Abstract #300148

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JSM 2003 Abstract #300148
Activity Number: 31
Type: Contributed
Date/Time: Sunday, August 3, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300148
Title: Comparison of Two Sample Size Adjustment Procedures in Clinical Trials
Author(s): Chenxiong Le*+ and Hsien-Ming James Hung
Companies: Food and Drug Administration and Food and Drug Administration
Address: CDER, 5 Chagall Ct., Gaithersburg, MD, 20878-3472,
Keywords: conditional power ; interim analysis ; Type I error ; power ; sample size
Abstract:

Sample size calculation plays a crucial role in the design of clinical trials. Sometimes the sample size calculation at the planning stage of a clinical trial is questionable and needs to be adjusted during the mid-course of the trial. Cui, Hung, and Wang (1999) proposed a procedure for sample size re-estimation in group sequential trials. Li, Shih, Xie, and Lu (2002) proposed a procedure for sample size adjustment based on the conditional power in two-stage trials. Both procedures control the Type I error rate and can provide a substantial gain in power with an increase of sample size. We compare the two procedures with respect to Type I error and power through simulation. Based on the sample size adjustment from the conditional power, the unconditional powers and sample sizes of the two methods are compared and discussed.

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