This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 90
Type: Roundtables
Date/Time: Monday, August 2, 2010 : 7:00 AM to 8:15 AM
Sponsor: Section for Statistical Programmers and Analysts
Abstract - #308875
Title: Interim Analysis: Does It Really Save Time?
Author(s): Jin-Yi Chen*+
Companies: Merck Research Laboratories
Address: 556 Morris Avenue , Summit, NJ, 07901,
Keywords: Interim Analysis ; DSMB ; Efficacy Analysis ; Sample Size Re-calculation

Interim Analysis (IA) is widely used in the clinical trials for the pharmaceutical industry. It tends to shorten the subject recruitment when the efficacy has been proved or terminate the study when it encounters major concerns of safety. An external Data Safety Monitoring Board (DSMB) needs to be formed and works closely with the Clinical Trial Team (CTT) to monitor the data, to evaluate the analysis results, and to provide the recommendation for the direction of the trial. Most of time, a CRO is also needed to participate for performing the IA. This talk is based on the experiences of running an IA for a Phrase 3A pivotal study. We will evaluate and summarize the experiences learned and provide the limitation of IA, and suggest how to improve the IA processing for the future projects.

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 2010 program

2010 JSM Online Program Home

For information, contact or phone (888) 231-3473.

If you have questions about the Continuing Education program, please contact the Education Department.