On Demand Webinar: FDA guidance on adaptive design – what does it means for you?
Tuesday, June 22nd, 2010
In Feb 2010 the FDA issued a draft guidance for industry on “Adaptive Design Clinical Trials for Drugs and Biologics” (pdf). Join Tom Parke in this on-demand webinar as he quizzes adaptive trial gurus Prof Don Berry and Dr Scott Berry on the implications of the FDA Guidance. Tom 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?
