Data and Safety Monitoring Boards Webinar Series: How to plan well and be prepared for the unexpected

Webinar recording, presentation slides and handouts

Webinar by Dr Carmel Hawley

Dr Carmel Hawley presented an update on data and safety monitoring boards for clinical trials. Carmel discussed:

• documents providing guidance around these boards and how they are approaching new challenges; 
• recommendations for the organisational structure;
• membership of DSMB, role of the chair, and conduct of meetings;
• responsibilities of the DSMB; 
• conflicts of interest; 
• sponsor responsibilities; 
• finances for DSMB activities;
• handling liability; 
• logistics of preparing for and conducting the meeting;
• principles of open and closed sessions; 
• reaching a consensus and making recommendations;
• preparing the outline of a charter and dummy report;   
• timetable for data cut, snapshot and distribution of data to DSMB members;
• presenting the data – format; 
• role of unblinded statistician and interaction and responsiveness to DSMB members, particularly DSMB statistician; 
• data presentation unmasked by treatment group? ;
• approaches to stopping rules for safety, efficacy or futility or logistics;
• what happens at the end of the study; 
• dealing with tricky situations;
• modifying monitoring boards to make them fit for purpose.