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.
Latest Resources
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STInG Chat – How to build a career as a clinical trials biostatistician
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Webinar recording: Historical and non-concurrent controls in clinical trials
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STInG Chat – ‘Securing Funding: Tips and Tricks for Investigator Grants’
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Webinar recording: Introduction to Git for Clinical Statisticians
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The processes involved in a Data and Safety Monitoring Board/Committee with special reference to the role of the various statisticians
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ACTA STInG grant advice for trial statisticians
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ACTA STInGChat – ‘Climbing the Career Cascade’
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Seamless Phase 2_3 Trials in Oncology
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Career paths for academic biostatisticians
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ACTA STInG: N-of-1 Trials Webinar Series – Webinar 2
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ACTA STInG: N-of-1 Trials Webinar Series – Webinar 1
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Effective strategies to manage data integrity risks webinar
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The Data Lifecycle: Ethical use of data webinar
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Transparency in data analyses webinar
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Webinar PIONEERing estimands in Clinical Research
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Estimands: Not just a statistical issue
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Resource for trial statisticians planning to apply for an academic promotion
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Guidance on Peer Reviewing the Statistical Aspects of a Medical Paper
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Protocols and Statistical Analysis Plans (SAPs) for Adaptive and Platform Trials
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Webinar: Estimands in Oncology – How and Why
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Seven steps for statistical success in clinical trials [Good clinical practice guidelines] Part 2
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Seven steps for statistical success in clinical trials [Good clinical practice guidelines] Part 1
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Data and Safety Monitoring Boards Webinar Series: Statistical Principles
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Data and Safety Monitoring Boards Webinar Series: How to plan well and be prepared for the unexpected
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Joint webinar on estimands in clinical trials
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Statistical Analysis Plan (SAP)
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Data Safety and Monitoring Boards (DSMB) for Adaptive Trials Webinar video
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Bayesian adaptive randomised clinical trials flyer
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ACTA STInG Notes from Members’ meeting, October 2019
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ACTA STInG 2017 Member Survey Results
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ACTA STInG Submission to the NHMRC Structural Review
Latest Events
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Webinar: Introduction to Git for Clinical Statisticians
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ACTA STInG Trials Webinar Series: Seamless Phase 2/3 Designs in Oncology
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ACTA STInG – Stata and R Markdown Demonstrations
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ACTA STInG 3 part webinar series on Data Transparency (DT)
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Clinical Trials 2021: National Tribute and Award Ceremony
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Clarifying clinical trial aims and analysis using the estimands framework
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Practical approaches to Adaptive Trial Simulation
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An Introduction to Adaptive Trial Designs
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Seven steps for statistical success in clinical trials [Good clinical practice guidelines] Part 2
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Seven steps for statistical success in clinical trials [Good clinical practice guidelines] Part 1
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Statistical principles – Data and Safety Monitoring Boards Webinar Series
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How to plan well and be prepared for the unexpected – Data and Safety Monitoring Boards Webinar Series
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Webinar: Data Safety and Monitoring Boards for Adaptive Trials
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Bayesian Adaptive Randomised Clinical Trials Workshop, Sydney
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Bayesian Adaptive Randomised Clinical Trials Workshop, Melbourne
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Bayesian Adaptive Trials Workshops: Perth