The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Abstract Details
Activity Number:
|
580
|
Type:
|
Contributed
|
Date/Time:
|
Wednesday, August 3, 2011 : 2:00 PM to 3:50 PM
|
Sponsor:
|
Biopharmaceutical Section
|
Abstract - #301207 |
Title:
|
Optimal Sample Size and Go/No-Go Decision Based on Probability of Success
|
Author(s):
|
Kaihong Jiang*+
|
Companies:
|
sanofi-aventis
|
Address:
|
BX2-400B, Bridgewater, , NJ, 08807,
|
Keywords:
|
Go/No-go decision ;
Probability of success ;
Program-wise planning ;
Optimal sample size ;
Bayesian ;
Phase II-III
|
Abstract:
|
In the course of a phase II/III clinical program, one faces a series of sample size determination (SSD) and decision problems: the simultaneous SSD for both phase II and III trials at the program planning stage, the go/no-go decisions after phase II data is observed, and the SSD of phase III trials incorporating phase II data. Conventionally, SSD are on trial-by-trial basis and independent of one another, and go/no-go decisions are made based on statistics, eg., p-values, that are ambiguous at times for decision making. In a combined Bayesian and frequentist framework, a probability of success (POS) function is proposed to allow an integrated approach to the SSD and go/no-go decision problems for a phase II/III program with a normal variable. For the first time, optimal sample sizes can be determined simultaneously for a phase II/III program based on the proposed POS function. As the POS function includes the conventional power function as a special case, it enjoys broader applications in trial planning than the power-based procedures, including SSD of phase II trials and that of phase III trials incorporating phase II data - neither can be handled readily by conventional methods.
|
The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
Back to the full JSM 2011 program
|
2011 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.