A concept for trial institutions focussing on randomised controlled trials in surgery

Description of the developments in surgical RCT infrastructure in Germany between 2001 and 2006. Cross sectional evaluation of completed and ongoing surgical RCTs within the German Surgical Society and the Clinical Study Centre, Department of Surgery, University of Heidelberg.Foundation of a national Clinical Trial Centre (CTC) for the organisation of multi-centre RCTs in the surgical setting (Study Center of the German Surgical Society, SDGC). Establishment of a network of CTCs with affiliated Clinical Sites (CSs) to enhance patient recruitment and shorten the duration of RCTs. Since its foundation four surgical RCTs with a total sample size of 1650 patients (1006 of these randomised) have been supervised by the SDGC with 35 CSs involved in patient recruitment. Five further CTCs were set up in 2006. Together with their affiliated CSs a network has been organised providing improved conditions for the conduction of surgical RCTs.Improvement of infrastructure substantially facilitates integration of RCTs into routine surgical practice. A network of collaborating CTCs and CSs can provide an adequate infrastructure for the conduction of multi-centre RCTs.Randomised Controlled Trials (RCT) are considered the reference standard for generating valid scientific evidence on benefits and harms of treatments in surgery [1]. However, the percentage of RCTs dealing with surgical interventions is still low. A Medline analysis revealed that only about 15% of all published RCTs were conducted in the surgical setting [2]. It is estimated that only 24% of surgical therapies are based on the results of RCTs [3].There are considerable national differences in the extent to which surgical RCTs (sRCTs) are pursued. In the United States the American College of Surgeons Oncology Group (ACOSOG) was founded in 1996 and is funded by the National Cancer Institute in order to increase the quantity and quality of sRCTs [4]. In Europe, the number of RCTs (adjusted for population size) conducted in