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Introduction: Transplantation medicine offers multiple translational questions which should preferably be transferred to clinical evidence. The current gold standard for testing such questions and hypotheses is by prospective randomized controlled trials (RCT). The trials should be performed independently from the medical industry to avoid conflicts of interests and to guarantee a strict scientific approach. A good model is an investigator initiated trial (IIT) in which academic institutions function as the sponsor and in which normally a scientific idea stands before marketing interests of a certain medical product., Methods: We present a model for an IIT which is sponsored and coordinated by Regensburg University Hospital at 45 sites in 13 nations (SiLVER study), highlight special pitfalls of this study and offer alternatives to this approach., Results: Finances: financial support in clinical trials can be obtained from the medical industry. Alternatively in Germany the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) offers annual grants. The expansion of financial support through foundations is desirable. Infrastructure: sponsorship within the pharmaceutics act (Arzneimittelgesetz) demands excellent infrastructural conditions and a professional team to accomplish clinical, logistic, regulatory, legal and ethical challenges in a RCT. If a large trial has sufficient financial support certain tasks can be outsourced and delegated to contract research organizations, coordinating centers for clinical trials or partners in the medical industry., Conclusions: Clinical scientific advances to improve evidence are an enormous challenge when performed as an IIT. However, academic sponsors can perform (international) IITs when certain rules are followed and should be defined as the gold standard when scientific findings have to be established clinically.

Basics for proper research are good ideas, know how and adequate resources. Essential to accomplish a research project in an efficient way is thorough planning. A research project can be divided in four organizational units. Writing of the protocol, which includes details about all relevant aspects, e.g. the research question, study design, time table and budget, second, details on data collection, third, data analysis and fourth, writing a report or manuscript for publication. A thoroughly developed protocol facilitates the communication between all involved persons and permits an efficient management of a research project.

After some general remarks on the current situation of child and adolescent psychiatric research in Germany, a research concept is presented which in the course of 30 years of testing and further development has proven to be successful both in the inauguration of scientific projects, as well as in the qualification of trainees and co-workers. The nucleus of this concept is a research unit that is to a large extent independent of the daily health care routine. Some of the unit staff members are natural scientists holding permanent positions, complemented by a secondary labour force of young doctors and psychologists aspiring to a scientific career. This research unit provides supply for scientific projects and basic research, as well as for the development of new methods. The unit was endorsed by a Clinical Research Group funded by the German Research Foundation (DFG) that proved of value as power supply for research (e.g. by raising substantial third-party funds) and as an instrument for the qualification of young scientists. The article describes some results of four research projects derived from this approach (schizophrenia research, dyslexia research, research on Asperger syndrome, quality assurance, and therapy evaluation research).