Scientific evaluation of modern clinical research: we need a new currency!

Abstract

In the age of evidence-based medicine, clinical trials are playing an increasingly central role [1, 2]. While the approval of new medicinal products justifiably requires phase III randomized controlled trials, diagnostic procedures and nonpharmacological therapies should likewise be subjected to needs assessments and risk assessments using the criteria of evidence-based medicine [3]. Consequently, the future of clinical research—and with it also the future of medical decision making—will be based to a large extent on prospective clinical studies [4]. In keeping with the rising standards, most good medical journals now carry a section on “clinical trials” or even “randomized clinical trials” because such studies engender prestige and citations in the publishing world [5, 6]. The Federal Coordinating Council for Comparative Effectiveness Research, the UK National Institute for Health Research, and the German medical research funding organizations, such as the Deutsche Forschungsgemeinschaft (German Research Foundation) and the Bundesministerium fur Bildung und Forschung (Ministry for Education and Research), all now support clinical trials as well as systematic reviews and metaanalyses [7–9]. Despite all these efforts and despite clearly positive developments in the direction of more evidencebased medicine, now as before, there remains a huge gap between intention and reality: there are far too few appropriately powered clinical trials that can justifiably be used to influence, even partially, the practice of medicine and surgery.