Methodology in Clinical Research

Course content

The effectiveness of new therapies (e.g. medications) must be proven with clinical trials. Recently, this has also applied to medical devices. A clinical trial is therefore carefully planned and conducted according to strict protocol. This is often contrasted with research work in (medical) informatics, in which algorithms are developed and "validated" with rather random experiments. Methods are thus taught that should be applied in all research areas.

The contents are:

• Paradigms of medical research and their framework (Good Clinical Practice, GCP)
• Types of clinical trials and human clinical trials
• Study design, participants and their roles, and conduct 
• IT support in study conduct
• Randomization with and without IT support
• Serious Adverse Events and IT support in their handling
• Evaluation of studies and publication.