Statistical principles - Data and Safety Monitoring Boards Webinar Series

Convenor: Professor Ian Marschner

Professor Ian Marschner, Professor and Co-Director of Biostatistics in the NHMRC Clinical Trials Centre, will present a discussion of the statistical principles that underlie the activities of data and safety monitoring boards for clinical trials. He will discuss: the potential problems that can arise when treatment comparisons are made repeatedly over the course of an ongoing trial; the potential for multiple analyses to inflate the chance of a false positive conclusion; the concept of group sequential statistical methods that allow valid statistical analysis of accumulating data while controlling the chance of false-positive conclusions; commonly used early stopping rules within the group sequential framework and the general concept of alpha-spending; other approaches to statistical monitoring including conditional power and Bayesian approaches.

Ian Marschner has over 30 years of experience as a biostatistician working on clinical trials and epidemiological research in cardiovascular disease, oncology and HIV/AIDS. His research also focuses on the development of new statistical methodology, particularly for designing and analysing clinical trials. He has over 100 peer-reviewed research publications and has been a Chief Investigator on research grants totalling over $20 million, including the Australian Trials Methodology Research Network (AusTriM), an NHMRC Centre of Research Excellence.

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