PSI Training Course: Data Monitoring Committees (DMCs)
Date: Tuesday 8th - Thursday 10th June 2021
Time: 8th 09:00-13:00 || 9th 14:30-16:30 || 10th 09:00-13:00 BST
Presenters: Andy Grieve, James Matcham, Julia Saperia, Thomas Jaki & David Kerr
Who is this event intended for? This training course is suitable for statisticians working on clinical trials which require a DMC.
What is the benefit of attending? Understand the different roles and responsibilities within a DMC, and have the chance to participate in a DMC within an interactive workshop.
NB: This course has Earlybird rates available. These are valid for bookings on or before 14th May only.
Earlybird Members = £250+VAT
Earlybird Non-Members = £345+VAT*
Regular Members = £290+VAT
Regular Non-Members = £385+VAT*
*Please note: Non-Member rates include membership for the rest of the 2021 calendar year.
This course is now available to book. To register your place, please click here.
Please note: Places for this course are limited and in high-demand, so please ensure you are able to attend all sessions before booking.
Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards, DSMBs) are responsible for the review of accumulating data from ongoing clinical trials. The DMC will advise the trial sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial (FDA Guidance for Clinical Trial Sponsor - Establishment and Operation of Clinical Trial Data Monitoring Committees). DMCs can also be used to analyse unblinded data for studies with group sequential design and other adaptive design elements to reduce potential operational bias.
Topics covered include:
• Introduction to DMCs
- Responsibilities within a DMC
- DMC charter
- Practical considerations
- Statistical monitoring methods
• DMC case studies
• Interactive DMC workshop
• Perspectives from the Independent Statistician
• Importance and expectations of a DMC from a regulatory perspective
• The new role of DMCs in adaptive designs and platform studies
• Experiences of DMCs during the pandemic
Please click here to view the flyer for this event.
Cancellation and Moderation Terms
For cancellations received up to two weeks prior to a PSI event start-date, the event registration fee will be refunded less 25% administrative charge. After this date, no refunds will be possible. A handling fee of 20 GBP per registration will be charged for every registration modification received two weeks prior or less, including a delegate name change.