Clinical research has outstanding significance, not only for the development of new medicines and other medical treatments, but also for ensuring and optimizing the treatment applications in daily routine. As far as research is bound up with commercial interests – for instance, the aim of obtaining marketing approval for a new substance – clinical research will be initiated and financed by the developer or manufacturer of the preparation or procedure; then the developer or manufacturer is the "sponsor" of the study. If the commercial expectations attached to the study results are however low or non-existent, in particular if the product already has market approval, often no private sponsor can be found. Clinical studies in the public interest without private financing are characterized as non-commercial clinical research, as science-initiated clinical tests or investigator-initiated trials (IIT), partly also as therapy-optimization studies.

In the 12th and 14th Amendment of the Medicines Act (AMG), the EU Directive 2001/20/EG of 4 April 2001 on the harmonization of laws and regulations of the Member States about implementing good clinical practice in the conduct of clinical trials with human medicines was adopted in German law. Here the non-commercial clinical studies are already accorded special significance; on the other hand, the requirements are regarded as very high and for the non-commercial clinical studies in particular in part as prohibitive.

The Directive 2005/28/EG of the EU Commission of 8 April 2005 to determine principles and detailed guidelines of good clinical practice for investigational products and requirements for their manufacture or import offers the possibility to introduce specific modalities for non-commercial clinical trials, in order to take into account their idiosyncrasies with regard to manufacture or import of the products to be investigated and the documentation of the studies. This makes it possible partly to reduce the requirements of non-commercial clinical studies and to facilitate their implementation. The question arises in particular to what extent exemptions should be made for the planning and conduct of non-commercial studies.

Objectives and approach

Little is known about the practice of non-commercial clinical research. Problem areas which are mentioned in this context are:

• responsibility of the sponsors
• Ethics Commission and the authorities
• notification and reporting obligations
• inspections
• pharmacovigilance
• monitoring
• clinical trials insurance
• labelling requirements
• financing of the study

The present analyses are based on estimates of individual experts or on group discussions about the possible impacts of the AMG Amendments, without an underlying systematic and quantitative problem analysis. Further possible influential factors outside the AMG which could also specifically affect the non-commercial clinical studies have been mainly missing in the discourse up to now. As it is not known how frequently the individual problems crop up, their significance for research practice cannot be reliably estimated.

Status and conditions of clinical research in general are being examined in the TAB Innovation Report "Biomedical Innovations and Clinical Research – Competition and Regulation Questions" presently being conducted. It is therefore no longer necessary to write a general chapter on clinical research in Germany.

The planned study should rather systematically collect data on the significance of the conditions presently being discussed as well as possible further conditions for practicing non-commercial clinical research in Germany. As no legal definition of "non-commercial clinical studies" exists, first of all a working definition must be found for the object of investigation. In order (to be able) to describe the starting situation, data on the frequency of non-commercial studies in Germany, their objectives, their financing etc. will be collected. The present discourse should be empirically examined from the perspective of all relevant actor groups for completeness and the agenda then amplified by neglected subjects. The practical importance of the single factors should then be recorded on the basis of the survey data, as well as in an expert workshop, and the most important options for action prioritized.

The study should treat its subject as compactly as possible, the data collection for stocktaking in the 32 German university hospitals and further research institutions could, however, be time-consuming, if previous experiences with similar projects can be gone by. A comprehensive international comparison of the framework conditions and practice in non-commercial clinical research would be less meaningful, as this sector especially is strongly integrated in the relevant national health care system and the framework conditions are therefore not comparable. Nevertheless, for special questions which crop up in the course of the project, solutions and "best practice" examples from other countries will be identified.