Interim Analysis: Does It Really Save Time?

• 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
• Author(s): Jin-Yi Chen*+
• Companies: Merck Research Laboratories
• Keywords: Interim Analysis ; DSMB ; Efficacy Analysis ; Sample Size Re-calculation

Abstract

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.