ACTA Webinar - Interim Data Sharing by Data Safety Monitoring Board: What to share, with whom, and why - Part 1

Abstract: Principal investigators and steering committees of randomized clinical trials routinely request data safety monitoring boards (DSMB) to share interim combined event rates. However, this practice can be challenging given the potential misinterpretation of the information, which can lead to biases and other unintended consequences. The main objective of this talk is to review the merits and demerits of sharing interim combined event rate by DSMBs. I will also review the fundamentals of DSMB process including stopping rules for benefit.

Dr Lehana Thabane

Dr. Lehana Thabane is a Vice President of Research at St Joseph’s Healthcare—Hamilton and St Joseph’s Health System; Scientific Director of the Research Institute at St Joseph’s Healthcare; Professor of Biostatistics in the Department of Health Research Methods, Evidence, and Impact at McMaster University. He is a Fellow of theRoyal Society of Canada, Fellow of the American Statistical Association, Fellow of the Society for Clinical Trials, Fellow of the Canadian Academy of Health Sciences, and Honorary Foreign Associate Member of the Academy of Science of South Africa. He is the Past President of the Society for Clinical Trials. He is the recipient of the 2022 of the Statistical Society of Canada Award for Impact of Applied and Collaborative Work. He was a recipient of an honorary degree from Stellenbosch University in South Africa in December 2023 for his contribution to clinical trial methodology.

Dr Thabane is the Emeritus Founding Editor-in-Chief of the journal Pilot and Feasibility Studies; and he is a member of the editorial board for many journals including Trials, and BMJ Open. He has co-authored over 1200 peer-reviewed manuscripts leading to significant contributions and transformation of science, healthcare, and delivery of care in many clinical areas. Having mentored over 200 graduate students and junior faculty, Dr Thabane has won several teaching and mentorship awards for his commitment to building capacity in health research and nurturing the next generation of researchers. 

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