Adaptive Designs in Clinical Trials

Key Topics

• Simulations: barriers for routine use and how to overcome them
• Designing a trial to find the minimum inhibitory concentration of an anti-infective drug
• Advances in methodology for phase ii/iii clinical trials
• The collaborative adaptive clinical trial design process: teamwork informed by simulation
• Case study: re-engineering phase 2
• Using simulation and biomarkers to speed phase i - ii development: a case study
• Revisiting the biomarker adaptive threshold design (batd) - is there a need for a study extension?
• Barriers and the future
• Predictive analytical techniques for modelling operational characteristics in clinical trials
• Designing an adaptive trial using a combination test for a survival endpoint
• Cost-effectiveness of alternative designs in cv outcome studies
• Designing multi-arm multi-stage trials with a safety and an efficacy endpoint
• Flexible designs in phase i pharmacokinetic trials
• Optimum adaptive design for dose finding in early clinical trials incorporating pk information
• Adaptive elements in clinical pharmacology trials

Who should Attend

Chief Executives, Directors, Vice Presidents, Chief Scientific Officers, Principal Scientists, Head of Departments and Statisticians within the Pharmaceutical or Healthcare industry with responsibilities in areas such as:

• Adaptive Trials Design
• Biostatistics
• Clinical Drug Development
• Regulatory Affairs
• Clinical Operations
• Contract Research
• Intellectual Property
• Research and Development
• Drug and Safety Assessment
• Legislation & Policy Advice
• Experimental Medicine
• Clinical Pharmacology
• Business Development
• Clinical Trials