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Wednesday 14 November 2018, 1:30pm to 5:00pm
Data and Safety Monitoring Boards (DSMBs) are a common feature of long-term clinical studies in serious and life-threatening conditions...
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.
Important please note:
We will make every attempt to accommodate Lancaster University staff and postgraduate research students on our courses. However, if a course becomes fully booked we reserve the right to give priority to students on the MSc in Statistics, MSc in Data Science, and external participants.
Details of course fees.
Payment: Once you have registered, please pay at the online shop
Accommodation Details: Can be found here.
Registrations are transferable to another course or individual at any time. Full refunds will be given for cancellation 10 or more working days before the course start date. Otherwise the full course fee will be charged.
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