CLINICAL RESEARCH IN SURGERY - QUESTIONS BUT FEW ANSWERS

Background: Surgeons must be prepared to be questioned about their und erstanding, activities, and achievements in basic and clinical researc h in terms of structural, organizational, and financial support of sur gical research. Results: Clinical research today comprises basic resea rch related to accumulation of knowledge about biological systems, dis ease-related research including experimental research with animals, an d in vitro research with biological material and clinical studies with the strongest empirical basis in data derived from controlled clinica l trials. Most clinical methods related to diagnosis and treatment hav e been introduced into the practice of everyday medicine even in unive rsity hospitals without passing a prospective evaluation protocol. To test the efficacy of a new drug or a newly developed surgical techniqu e, the controlled prospective clinical trial is the best method; howev er, fewer than 50% of clinical questions can be answered by controlled clinical studies. In Germany the frequency of controlled clinical tri als for answering clinical questions is presently low; this is particu larly true for surgery, in comparison with other countries. The concep t of evidence-based medicine is based on the principles of data genera tion from controlled trials and meta-analyses of those studies. Best-e vidence synthesis means a reasonable synthesis of evident knowledge, e xperience and intuition. The challenge of professionalization of clini cal research in surgery is linked to the establishment of full time po sitions for basic scientists and clinical researchers and the establis hment of clinical research teams and of research professorships includ ing basic scientists in surgical departments. Conclusion: Clinical res earch can be effective only if there is good cooperation between clini cians and basic scientists, if high grade scientific methods are estab lished in clinical research institutions, if there is sufficient finan cial and personal supply, and if there are enough laboratories and ani mal operating facilities. There is an urgent need for structures integ rating basic scientists in clinical research groups, for more interdis ciplinary research projects and more multidisciplinary research, indep endent of clinical care in terms of manpower.