Data and Safety Monitoring Boards course
Date:
24/10/2017
Organised by:
Lancaster University
Presenter:
Dr Thomas Jaki
Level:
Intermediate (some prior knowledge)
Contact:
Angela Mercer, Tel: 01525 593064, psc@lancaster.ac.uk
Map:
View in Google Maps (LA1 4YF)
Venue:
Department of Mathematics and Statistics
C/o Postgraduate Statistics Centre
Lancaster University
Lancaster
Description:
Data and Safety Monitoring Boards (DSMBs) are a common feature of long-term clinical studies in serious and 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.
Cost:
External from industry/commerce £125; External from academic institution/public sector/charity staff £110 and External postgraduate £75
Website and registration:
www.lancaster.ac.uk/maths/postgraduate/short-courses/
Region:
North West
Keywords:
Data Management , Data security
Related publications and presentations: