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
- Pharmacovigilance scientists
- Clinical research associates
- Clinical trial operations staff