[Quality requirements governing non-commercial clinical trials within the framework of clinical drug development in humans in the EU. Challenges, opportunities, and questions experienced by treatment centres].

Therapeutic evidence of a given drug treatment develops via "approval studies" and clinical "therapy optimisation studies". Legislation has been faced with the challenge of providing common legal guidelines regarding the requirements governing such a broad spectrum of studies, and to realize their application. Numerous definitions and regulations today provide specifics in a previously insufficiently regulated grey area. The European frame-it is hoped-facilitates international co-operation. Possibly, clearly phrased legal requirements might also improve the co-operation between the pharmaceutical industry and treatment centres to work in the interest of patients incapable of giving consent and of minors. Requirements regarding the responsibilities of the sponsor, insurance for trial subjects, double approval procedures, handling of medicinal products to be tested and others are not easily fulfilled under the existing, real-life conditions of clinical trials. It is obvious that the cost of clinical trials will soar and trial sites and sponsor institutions will have to make investments for structural adaptation. In fulfilling those requirements trials might gain in procedural quality and probably outcome quality as well. Not every study discontinued due to lack in funding will be a true loss. We are, however, faced with the real threat of losing established structures of quality control and of entering a phase of stagnation in clinical research on rare diseases and "small" questions. At present, the challenge lies in co-operating with the authorities to explore the scope of those regulations to apply them effectively and in a useful manner, so that there will be better quality and increased evidence rather than less progress.