JSM 2005 Online Program

Abstract #303362

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	218
Type:	Topic Contributed
Date/Time:	Tuesday, August 9, 2005 : 8:30 AM to 10:20 AM
Sponsor:	Biometrics Section
Abstract - #303362
Title:	When Is Statistics Not the Answer: Allowing for Flexibility in Phase II Clinical Trial Design
Author(s):	Daniel Sargent*+ and Susan Geyer
Companies:	Mayo Clinic and Mayo Clinic
Address:	200 First Street SW, Rochester, MN, 55905, United States
Keywords:	Screening Design ; Randomized Phase II ; Clinical Trials ; Interim Analyses
Abstract:	The application of appropriate statistical methodology in the clinical trial setting has arguably led to a substantial increase in the quality of these studies. However, in some settings there remains difficulty in the application of standard statistical methods such as hypothesis testing. One such setting is the area of Phase II clinical trials. In this talk, I will review two recent designs for different types of Phase II trials that extend standard methods to allow for flexibility in the decisionmaking process. The first design focuses on the standard single-arm Phase II and the second on the randomized Phase II. The flexibility arises from the explicit consideration of a prespecified "uncertainty region," whereby when results fall into this region, factors in addition to the primary endpoint are allowed to enter into the decisionmaking process. Each of these designs will be described and the advantages and disadvantages of the flexible approach to study design will be discussed. I will then introduce two extensions to the flexible randomized phase II screening design, which allows for an interim analysis and a comparison to historical controls.

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