Design and Statistical Analysis of Clinical Trials

About the Course

Do you want to strengthen your understanding of statistics in clinical trials? This course provides you with the tools to navigate the design, analysis, and reporting of clinical trials – for both drugs and medical devices. With practical exercises and insight into regulatory requirements, you will gain the knowledge to communicate effectively with statistical experts. The course is given in Swedish (Design och statistisk analys av kliniska prövningar).

Who Should Attend

The course is aimed at individuals involved in the design, statistical analysis, and interpretation of results from clinical trials. You might work as an investigator, clinical trial manager, project manager, medical director/advisor, medical writer, data manager, in Regulatory Affairs, or be new to the role of a statistician.

Learning Objectives

After the course you should have reviewed basic descriptive statistical measures and gained advanced knowledge in the design and statistical analysis of clinical trials. This will enable you to communicate with statistical experts and assess when it’s necessary to consult them. You will also have a deeper understanding of the regulatory requirements surrounding statistical aspects of clinical trials.

Course Content

The course is structured around lectures and practical exercises, so you should have a computer available with Microsoft Excel installed. The course covers topics such as:

• Basic statistical terms
• Outcome variables
• Objectives and design
• Control groups
• Sample size calculation
• Statistical analysis plan