Sven Schmiedl

Clinical trials make an important contribution to medical progress. In order to ensure patient safety and the validity of study results, clinical research is subject to a variety of ethical, legal and regulatory frameworks.

The Professorship of Clinical Trials and Regulatory Aspects is associated with the scientific management of the Centre for Clinical Trials at Witten/Herdecke University. In addition to the regulatory categorisation of research projects, the content and methodological support in the development of research ideas is a key focus of the professorship.

As part of the scientific management of the ZKS of the UW/H, a major focus of the professorship is to support the content of all research colleagues in the Faculty of Health. Among other things, help is offered with the preparation of essential documents (e.g. protocol) and networking with other disciplines (e.g. biometrics) is supported.

A second focus of the professorship is on analysing clinical research at the meta-level. Essential aspects here are analysing barriers to participation in clinical research projects and identifying factors that facilitate participation in and the implementation of clinical research. One of the research topics here is the evaluation of expense allowances paid in the context of Phase I studies. In addition, studies on the use of drugs are also carried out (secondary data analyses).

• Dr rer. nat. Rene Geißen (Management)
• Stefan Bauer (Data Management)
• Veronika Bencheva (Research Assistant)
• M.Sc. Katharina Graf (Research Assistant)
• M.Sc. Mpopa Kibungu (Research Assistant)
• Dr rer. nat. Judith Knievel (Project Management)
• Dipl.-Biol. Marcel Königs (Data Management)
• Dr rer. nat. Rebekka van Zyl (Project Management / Clinical Monitor)
• Michael Hoffman (doctoral student)
• Annika Wallau (PhD student)
• Fabian Föhrenbacher (doctoral student)
• Lea Rikl (doctoral student)

As part of the "Scientific work" course series, students in the 6th semester learn about the ethical, legal and methodological aspects of clinical research. The knowledge acquired is further deepened in journal clubs and applied by the students in the evaluation of publications in the field of clinical research.

In addition to clinical education, further training is offered in the area of Good Clinical Practice in the field of drug and medical device law in accordance with the requirements of the German Medical Association.

• Lecture on scientific work/clinical research
• Journal Club