Clinical research in surgery: questions but few answers

Abstract

Background: Surgeons must be prepared to be questioned about their understanding, activities, and achievements in basic and clinical research in terms of structural, organizational, and financial support of surgical research. Results: Clinical research today comprises basic research related to accumulation of knowledge about biological systems, disease-related research including experimental research with animals, and in vitro research with biological material and clinical studies with the strongest empirical basis in data derived from controlled clinical trials. Most clinical methods related to diagnosis and treatment have been introduced into the practice of everyday medicine even in university hospitals without passing a prospective evaluation protocol. To test the efficacy of a new drug or a newly developed surgical technique, the controlled prospective clinical trial is the best method; however, fewer than 50% of clinical questions can be answered by controlled clinical studies. In Germany the frequency of controlled clinical trials for answering clinical questions is presently low; this is particularly true for surgery, in comparison with other countries. The concept of evidence-based medicine is based on the principles of data generation from controlled trials and meta-analyses of those studies. Best-evidence synthesis means a reasonable synthesis of evident knowledge, experience and intuition. The challenge of professionalization of clinical research in surgery is linked to the establishment of full time positions for basic scientists and clinical researchers and the establishment of clinical research teams and of research professorships including basic scientists in surgical departments. Conclusion: Clinical research can be effective only if there is good cooperation between clinicians and basic scientists, if high grade scientific methods are established in clinical research institutions, if there is sufficient financial and personal supply, and if there are enough laboratories and animal operating facilities. There is an urgent need for structures integrating basic scientists in clinical research groups, for more interdisciplinary research projects and more multidisciplinary research, independent of clinical care in terms of manpower.