Dr. Michael Obermeier, Head of Biostatistics at GKM, lectures at the FORUM seminar “Good Clinical Study Design”.

The study design is the basis for the successful completion of a clinical trial. However, regulations, guidelines for patient safety, financial considerations and the practical feasibility set narrow limits to creativity. This seminar informs you about the regulatory framework and shows you how you should approach study planning and the definition of study design in a very practical way.

• What is the authority’s focus when assessing the design?
• How do you proceed methodically on the planning timeline?
• Which statistical considerations play a role?
• And how is the project assessed from an ethical perspective and in terms of patient safety?

This seminar focuses on innovative and complex study designs such as adaptive, basket and umbrella, which are becoming increasingly important for clinical trials.

Read more: https://www.forum-institut.de/seminar/2002242-good-clinical-study-design