[Concept for nationwide cooperation in planning and implementing multicenter studies]

In Germany, good clinical multicenter studies that are not supported by pharmaceutical companies are rarely performed. Good supranational industry-sponsored studies are usually aimed at the registration of new (expensive) drugs. The preconditions for co-operation in conducting industry-independent studies which are of interest for the scientific community have been improved substantially in Germany by instituting the working group of co-operating arthritis centers, the so-called core documentation where 32,000 patients with rheumatic conditions were documented in 1997 and the institution of a sophisticated information system ("RheumaNet"). The executive board of the German Rheumatology Association has set up an "ad hoc commission" that agreed to institute a "Committee for the Coordination of Clinical Studies in Rheumatic Diseases". In this committee rheumatologists subspecialized from medicine, orthopedic, pediatrics working in universities, hospitals and private practice as well as specialists in statistics and epidemiology shall be represented. In principle this committee is independent of the co-operating arthritis centers and the RheumaNet. All members of the German Rheumatology Association are invited to cooperate with this committee by contributing to the clinically important questions and participating in clinical studies. The committee has to define key questions in rheumatology and shall plan and organize multicenter studies to answer these questions. In addition, study protocols of pharmaceutical companies may be examined as to their importance, quality, and feasibility.