Course Details

One day classroom course with a mix of presentations and workshop sessions

This Course is designed to equip the participant with the essential knowledge as to the requirements of sample sizing which include the key components of power, significance and assumptions. This course is not designed to be statistical and will include no mathematics or formulae, instead this gives a practical insight into how sample sizing is done and the most effective approaches to it.

The Course is a blend of theory and practical hands-on experience using sample sizing software to compute real sample sizes and explore the various assumptions.

This course is suitable for anyone involved in the design of clinical trials or involved in writing clinical trial reports or manuscripts, including: 

• CRAs
• Project Managers 
• Medical Advisers 
• Investigators 
• Medical Writers
• Project Accountants 

The Key Components 

• Power
• Significance and relationship to p-value
• Assumptions
• Standard deviation

Framework for Sample Sizing 

• Obtaining estimates and assumptions
• Deciding on power
• Sample sizing process

Sample Sizing Continuous Data 

• Assumptions & Methods
• Practical Examples

Sample Sizing Binary Data 

• Assumptions & Methods
• Practical Examples

Sample Sizing Time to Event Data 

• Event Driven Trials (time to death, progression etc)
• Additional assumptions
• Event rates leading to sample size
• Practical Examples