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

Abstract Details

Activity Number: 61
Type: Topic Contributed
Date/Time: Sunday, August 1, 2010 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307151
Title: Follow-Up of Subjects in Event Rates for Periodic Safety Monitoring Reports in Open Enrollment Clinical Trials
Author(s): Maria Carola Alfaro*+
Companies: Boston Scientific Corporation
Address: 4100 Hamline Avenue North, St. Paul, MN, 55112-5798,
Keywords: Event Rate ; Safety Monitoring Reports ; Follow-up Time

Event rates are used to assess efficacy and safety in clinical trials. An event rate is defined as a ratio of the number of subjects who had at least one event during a specified period of time divided by the total number of subjects at risk of the event during a specified period of time. Identifying the number of subjects at risk can be complex in an ongoing open enrollment trial, especially when subjects have not been followed to the time-point of interest. We will explore different scenarios to attempt to determine the most appropriate length of follow-up subjects need to experience before they can be considered at risk for the event.

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