[Design and evaluation of the University of Munich courses on research trials].

introductionThe growing importance of clinical research in Germany requires physicians who are adequately trained to conduct clinical trials. In November 2007, the Coordination Centre for Surgical Studies at the University of Munich organised its third course for clinical investigators. The course was evaluated by the participants. PARTICIPANTS AND PROGRAMME: Participants included 1st-year residents as well as specialists mostly from surgical departments; many already possessed significant experience with clinical trials. In our course, special emphasis was put on the practical aspects of conducting clinical trials. EVALUATION: On a scale from 1 to 6 (in German grading, 1 is the best score), participants rated content at 1.5, understanding at 1.6, and learning effect at 1.8. Careful preparation and a clearly structured curriculum resulted in significantly better evaluation of this course than of preceding courses (content P=0.015, understanding P=0.007, learning effect P=0.018). DISCUSSION: To realise projects of translational investigation and to participate in interdisciplinary clinical trials, surgeons in academic centres should obtain basic knowledge on clinical and pharmaceutical trials. Participants' statements on their own experience as clinical investigators underline the need for adequate training in this field. This course conveys essential knowledge of good medical practice and critical review of medical literature. We view this knowledge as a basic skill for modern medical practice and have therefore integrated the course into basic surgical training at our department.

conclusionThe concept of training for clinical investigation conducted at a surgical department is well established, and the participants' positive feedback motivates us to continue organising such courses.