Adaptive trials and writing clinical trial simulators workshops

Two workshops on “Adaptive Trials” and “Writing Clinical Trial Simulators” were held in Melbourne on March 22nd and 23rd. Organised and hosted by the Australian Clinical Trials Alliance (ACTA) Statisticians in Trials Interest Group (STInG) and the ACTA Innovative Trials Design and Conduct Reference Group with sponsorship from the Statistical Society of Australia and the Melbourne Academic Centre for Health, the workshops aimed to bring together statisticians and clinicians working in the area of clinical trials to share knowledge and information on setting up and conducting adaptive trials.

Adaptive clinical trials allow for un-blinded looks at the accumulated data with the potential to adjust the course of the study while it is still ongoing. The Adaptive Trials Workshop attracted 88 attendees from across Australia. During this full-day workshop, eight statisticians and clinicians (A/Prof Stephane Heritier, Dr Julie Marsh, Dr Tom Snelling, Prof Steve Webb, A/Prof Mustafa Khasraw, Prof Leonid Churilov), including 2 international visitors (James Matcham [UK] and Dr Todd Graves [US]), with expertise in designing, running, and reporting of adaptive clinical trials presented the underlying theory illustrated with case-studies. The day ended with a discussion around where to next with adaptive trials. The half-day Writing Clinical Trial Simulators Workshop was attended by 35 statisticians and clinicians and was presented by Dr Todd Graves, a statistician from Berry Consulting based in the US. Dr Graves has extensive experience with simulating complex trial designs and in particular platform trials, an innovative trial design based on Bayesian methodology. The workshop introduced the concepts, software, and engineering skills required to write simulation programs to estimate the operating characteristics (e.g., type-1 error, power) of a trial whose design is too complex to plan using available standard software.

Both workshops were received with great enthusiasm by the Australian clinical trials community and plans of hosting an adaptive trials workshop in other states in the near future are already underway.

Sabine Braat and Katherine Lee

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