This course will focus on practical issues around the workings of data monitoring committees (DMCs) including a review of group sequential methods and FDA and CMHP guidance on DMCs. Throughout the course, mock DMC sessions will be convened where various scenarios will be considered and discussed, and decisions have to be made.
Advantages and disadvantages of early stopping of trial
Stopping ‘rules’, including Haybittle and Peto, Pocock, O’Brien and Fleming, alpha-spending approaches, Bayesian methods
CHMP, FDA (and other) guidance documents
How do DMC meetings run? – Frequency, location, structure, attendance
Practical problems (dissemination of information (including minutes), independence, communications)
Who should attend?
Drug Product Development scientists
Regulatory Managers and specialists
Clinical Development staff
Clinical research associates
Clinical trial operations staff
Dr. Simon DayDirector at Clinical Trials Consulting & Training