Clinical Trials Working Group Meeting and AGM

Thursday 10th August, 1115-1530hrs

1115-1230 Session Title:  Multi-Centre Trial Design and Management
Chair:  Chris Reid
 Meeting Room 6
1115-1120 Introduction  Chris Reid, WA
1120-1150 Adaptive Clinical Trials for Cardiovascular Disease

An adaptive clinical trial allows certain trial design features to change during the course of the trial based on observed data within the trial.  These adaptations are planned prospectively and are used to increase trial efficiency and to increase the probability of achieving the scientific goals of the study.  Such trial designs may include frequent interim analyses, adaptive sample sizes, longitudinal modelling of time-delayed outcomes, borrowing of historical data, study population enrichment, or response adaptive randomization.  We discuss common adaptations in trials for cardiovascular disease, illustrating the benefits compared to traditional designs, and provide examples of real trial designs. 

Ben Saville, USA
1150-1230 Multi-Centre Trial Management – the Hamilton Experience  Jackie Bosch, Canada
1330-1500 Session Title:  Establishing the Australia New Zealand Alliance for Cardiovascular Trials (ANZACT)
Chairs:  Derek Chew and Anushka Patel
1330-1350 Progress since February Meeting  
1350-1420 Trial 1  
1420-1450 Trial 2  
1450-1500 Network Endorsement  
1500-1530 Clinical Trials Council AGM  

Speaker Biographies

Ben Saville, Ph.D.
Ben Saville is a Statistical Scientist for Berry Consultants, where he specializes in the design of innovative Bayesian adaptive clinical trials. He works primarily with medical device companies, pharmaceutical companies, and academic investigators to solve challenging problems via Bayesian designs, many of which are reviewed by the U.S. Food and Drug Administration (FDA). He is a frequent invited speaker at various statistical conferences, academic seminars, and lecture series, including short courses on adaptive clinical trial design. Dr. Saville earned his Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill in 2008. Prior to joining Berry Consultants in 2014, he was an Assistant Professor of Biostatistics at Vanderbilt University School of Medicine where his methodological research focused on Bayesian hierarchical models, Bayesian adaptive clinical trials, and nonparametric methods for randomized clinical trials.

Jackie Bosch
Dr. Jackie Bosch has been coordinating some of the most significant cardiovascular randomised trials over the past decade and will provide insights into the challenges on making these trials work.
Dr. Bosch has focussed her efforts on the conduct of large, multinational clinical trials in the areas of primary and secondary cardiovascular disease and diabetes prevention Dr. Bosch is interested in the design of clinical research and in improving the efficiency of conducting clinical trials, and has been involved in the Sensible Guidelines working group to improve key aspects or research implementation. She has also been part of the faculty who provide the international Clinical Trials courses offered by PHRI and has co-chaired the Canadian Initiative to Streamline Clinical Trials. She currently oversees the conduct of three large trials and numerous smaller projects.
Dr. Bosch’s clinical interest is in the area of functional outcomes, and she has worked with colleagues to develop functional outcome measures that can be used in large, international trials. She leads the functional outcome data collection, along with cognitive and physical measures, in two large studies. She is also Co-investigator on two post-stroke intervention trials, one to improve mobility in those with impairments and the other to implement stroke units in low and middle income countries. She is a full time faculty member in the School of Rehabilitation Science as well as an Investigator at the Population Health Research Institute, both at McMaster University.

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