June 22, 2010
In Feb 2010 the FDA issued a draft guidance for industry on “Adaptive Design Clinical Trials for Drugs and Biologics” (pdf).
Join me in this on-demand webinar as I quiz adaptive trial gurus Prof Don Berry and Dr Scott Berry on the implications of the FDA Guidance. I will be getting answers to the key questions the guidance raises, namely:
- What are the major conclusions of the guidance?
- How does the guidance affect the future of clinical design?
- Is it positive or negative for adaptive designs?
- What role does Bayesian play in the guidance…if any?
- What role, if any, does simulation play in the guidance?
- Why has Phase III been so clearly differentiated from earlier phases in the guidance?
Play the webinar
Tom Parke
Tom Parke is head of clinical trial solutions at Tessella and has been working at Tessella for over ten years. For a large part of that time he has been working on Adaptive Clinical Trial projects particularly with Dr Mike Krams and Don and Scott Berry at Berry Consultants.
Tom has helped implement numerous adaptive phase 2 dose finding trials that are now complete, for a range of pharmaceutical companies across a range of indications. For these trials, he managed the development of simulation tools, systems to support the running of the trials and the integration of adaptive algorithms with existing IVRS and EDC systems.
He is currently working on his 12th adaptive dose finding trial, and consulting with a number of companies to help them define the software systems they require to move adaptive clinical trials into their mainstream activities. Before working at Tessella, Tom had worked at Praxis (part of Deloitte & Touche) most notably managing projects for part of the air traffic control system at Heathrow Airport, and control software for imaging systems for GE Medical Systems and Varian Oncology.
