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

Convenor: Professor Carmel Hawley

Carmel Hawley will present an update on data and safety monitoring boards for clinical trials. She will discuss: 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.  

Carmel Hawley MB BS (Hons) M.Med Sci (Medical Statistics) FRACP, is a physician researcher and Clinical Trialist. Her clinical expertise is in Nephrology and is currently Assistant Director for the Haemodialysis program at the Princess Alexandra Hospital, Brisbane, Queensland, Australia,  Professor of Medicine UQ and the Inaugural Chair of the Executive Operations Secretariat for the Australasian Kidney Trials Network (AKTN), a collaborative research network that has to date enabled over 18 multi-centre investigator-initiated clinical trials, many in collaboration with international research partners.  She has been involved in DSMB activities for 15 years for activities related to investigator-initiated trials.  Professor Hawley is a Fellow of the Academy of Health and Medical Sciences, and a key member of several national and international collaborations.  She has published over 400 peer-reviewed articles and has been the recipient of upwards of $47,800,000 in research grant funding, primarily from the National Health and Medical Research Council’s federal grant program. In recognition of her significant contribution to the field of nephrology research, in 2018 Professor Hawley was awarded Kidney Health Australia’s highest accolade, the Kincaid-Smith medal.