Data and Safety Monitoring Board Workshop
@ The University of Reading, UK
28 October 2005
Presenter:
Dr Sue Todd
Guest Presenter:
Dr Julian Bion
Reader in Intensive Care Medicine
Queen Elizabeth Hospital, Birmingham
Audience:
This Workshop is designed for people who serve on Data and Safety Monitoring Boards, people who organise them, and people involved in preparing adverse event and statistical reports for them.
Description:
Data and Safety Monitoring Boards (DSMBs) are a common feature of long-term clinical studies in life-threatening conditions. This Workshop describes the remit and composition of DSMBs, and how their work relates to other parties involved in the study, such as the sponsor, the study project team, the investigators, the Steering Committee and the data management centre. The importance of pre-trial preparation by the DSMB is stressed. Consideration is given to the nature and purpose of safety and efficacy data reports presented to the DSMB, and the balance between the timeliness and the accuracy of the data available is discussed. Statistical problems inherent in repeatedly making multiple treatment comparisons are highlighted, and formal stopping guidelines based on repeated safety analyses are presented. The role of the DSMB in trials with pre-specified interim efficacy analyses will be discussed.
The Workshop is structured around group discussions of realistic scenarios of the type faced by DSMBs.
Programme:
* Role and composition of a DSMB
* Confidentiality and blindness
* Presentation of safety reports
* Formal stopping rules for safety
* Interim efficacy analyses and sequential designs
Course fees:
For 6 or more weeks prior to commencement of the course:
Students £180
Sponsors/Public £225
sector/Academic
Other £255
Less than 6 weeks prior to course: £300
The course fee includes all supporting documentation, refreshments and lunches. For a course running more than one day, dinner is included on the first evening.
Cancellation:
Registrations are transferable to another course or individual at any time, otherwise cancelled course registration will incur the following charges:
11 - 20 days before the start of the course 50%
1 - 10 days before the start of the course 90%
course start date or later 100%.
We reserve the right to cancel any course without liability other than a refund of the course fee.
Booking form:
http://www.rdg.ac.uk/mps/mps_home/courses/scheduled_c.htm
For further information please contact:
Barbara Dodds
MPS Research Unit
The University of Reading
PO Box 240, Earley Gate
Reading, RG6 6FN
Tel: 0118 378 6662
e-mail: [log in to unmask]
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