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
|
Abstract:
|
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.
|
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 jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.