Innovative Statistical Approaches for Clinical Trials

• Focuses on answering common questions and addressing topics such as:
• Modeling
• Multiplicity adjustments
• Non-inferiority
• Data mining
• Adaptive designs
• Bayesian principles
• Survival methods
• Use knowledge gained from the course to improve your contribution to clinical investigative teams
• Interactive discussions and activities to practice the concepts
• Applying advanced statistics to design studies, analyze data, and interpret results

• Those who have completed Clinical Statistics for Nonstatisticians
• Clinical research professionals
• Project managers
• Decision makers who use statistics to describe potential impact on studies and programs

At the conclusion of this activity, participants should be able to:

• Identify ways to use statistics to make better decisions in the drug development process
• Describe what a statistical model can and cannot do in terms of trial design and management
• Recognize why multiplicity adjustments may be necessary and identify the pros and cons of these adjustment methods
• Describe clinical equivalence and non-inferiority clinical trial designs
• Describe the basis of Bayesian methods
• Identify adaptive design approaches and recognize issues in their implementation and interpretation
• Describe how survival trials can be analyzed and adapted
• Effectively speak to co-workers and management using advanced statistical terms