[Effects of the 12th amendment to the German drug code on investigator-initiated clinical trials].

Purpose of the Study: Non-commercial investigator-initiated trials are an important part of clinical research in Germany. Academics who want to initiate clinical trials are confronted with the new and complex regulatory framework of the 12(th) Amendment to the German Drug Code. This paper studies the effects of this new regulatory framework on different important aspects of clinical trials.
Methods: A total of 87 people who are engaged in planning, conducting or analysing investigator-initiated clinical trials were included in the study. The professionals are employed at university hospitals, coordinating centres for clinical trials, and contract research organisations. The survey took place using a web-based, anonymous questionnaire.
Results: The interviewed professionals described a general increase of regulatory requirements and complexity in investigator-initiated clinical trials, as well as an increase in expenditure of time and total costs. However, there is also an observed improvement in the quality of clinical trials.
Conclusion: The new regulatory requirements of the 12(th) Amendment to the German Drug Code have led to an increasing professionalisation in planning and conducting clinical trials in an academic environment. In particular, university hospitals have been confronted with large challenges.
(© Georg Thieme Verlag KG Stuttgart · New York.)