|
Activity Number:
|
557
- Data Monitoring Committees – the Multi-Disciplinary Approach to Drug Safety Assessment
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Wednesday, July 31, 2019 : 2:00 PM to 3:50 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
|
Abstract #304222
|
Presentation
|
|
Title:
|
The Perfect DMC – a Multi-Disciplinary Approach to Monitor Patient Safety:
|
|
Author(s):
|
Jonathan Seltzer*
|
|
Companies:
|
ACI Clinical
|
|
Keywords:
|
DMC;
DSMC;
Patient Safety;
Data Monitoring ;
Clinical Trial Safety ;
Committee
|
|
Abstract:
|
Although “Data and Safety Monitoring” receives our focus, “Committee” is of equal importance to ensure peak performance of DMCs. Optimal data and safety monitoring requires correct committee composition as well as cooperation between committee members and the statistical and analytical support. This is easier said than done. This session will discuss key factors in selection of the proper committee members as well as principles to ensure optimal and dynamic communication between the statistical center and committee members throughout the trial.
|
Authors who are presenting talks have a * after their name.
