Karl und Veronica Carstens-Stiftung im Stiftverband für die Deutsche Wissenschaft

The Concept of Pragmatic Clinical Research or the End of Discussion about 'Placebo' and 'Specific Effects&rsquoThe reorientation of clinical research towards the questions of treatment benefit (beyond the question of treatment efficacy) and of how much clinical trials represent actual practice (external validity) is the timely path to clinical research questions of real interest and importance. Postmodern 'anything goes' makes it possible to also consider thus far looked down on placebo effects as valuable, however, it requires the precise documentation of the external validity of such effects. Not disease as such, but the disease context, not therapy as such, but the therapy context, not the patient as such, but the patient context, not a test as such, but the test situation have become the important focuses of clinical research. In respect to test results current medicine has to recognize its illiterate mystification of allegedly 'objective' and 'hard' data. The patient context can determine whether an 'efficacious' therapy is beneficial or harmful, and thus, it is the proper definition of the patient context which makes medicine scientific, no matter how 'objective' or 'subjective' the effect of therapy is. The consideration of the therapy context leads to the important distinction between efficacy and effectiveness (or benefit), and it becomes intelligible that the randomised controlled trial in its traditional design as the placebo-controlled double-blind trial is limited to the evaluation of an agent theory. The evaluation of treatment effectiveness requires more pragmatic trials which study treatment operations and not isolated components and which may even compare entire treatment strategies. Pragmatic clinical trials, in future, will not only allow the study of 'pathogenesis blockers'., but also the study of 'salutogenetic' interventions working with the formation of the host. The focus of attention and research in the new school of evidencebased medicine with clinical epidemiology as its basic science (if not superficially understood as mere literature medicine) has long ago been identified as illness as the product of host, disease and environment. The dispute about 'placebo' and 'specific effects', in the meantime, has become obsolete.