Abstract
BackgroundAlthough considered the reference standard for generating valid scientific evidence of a treatment's benefits and harms, the number of Randomised Controlled Trials (RCT) comparing surgical techniques remains low. Much effort has been made in order to overcome methodological issues and improve quality of RCTs in surgery. To the present there has been, however, only little emphasis on development and maintenance of institutions for implementation of adequately designed and conducted surgical RCTs.Mehods/DesignDescription 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.ResultsFoundation 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.ConclusionImprovement 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.
Highlights
Considered the reference standard for generating valid scientific evidence of a treatment's benefits and harms, the number of Randomised Controlled Trials (RCT) comparing surgical techniques remains low
Since its foundation four surgical RCTs with a total sample size of 1650 patients (1006 of these randomised) have been supervised by the Studienzentrum der Deutschen Gesellschaft für Chirurgie (SDGC) with 35 Clinical Sites (CSs) involved in patient recruitment
A network of collaborating Clinical Trial Centre (CTC) and CSs can provide an adequate infrastructure for the conduction of multi-centre RCTs
Summary
Considered the reference standard for generating valid scientific evidence of a treatment's benefits and harms, the number of Randomised Controlled Trials (RCT) comparing surgical techniques remains low. Randomised Controlled Trials (RCT) are considered the reference standard for generating valid scientific evidence on benefits and harms of treatments in surgery [1]. The German Science Council already recognised a lack of patient-oriented clinical research in Germany in the early 1990s, major national problems, i.e. lack of funding and a weak infrastructure for the implementation of surgical trials, were still present in 2003 [7]. Within the last few years much effort has been invested into forming a working national infrastructure in surgical departments and the German Surgical Society (Deutsche Gesellschaft für Chirurgie) in order to establish an environment in which high-quality sRCTs can be performed on a larger scale
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