Evaluation of the infrastructure for clinical surgical studies in Germany : A nationwide survey of the surgical study network CHIR-Net

Abstract

In order to improve the quality and quantity of clinical trials in Germany asurgical study network called CHIR-Net funded by the Federal Ministry of Education and Research (BMBF) was established. The focus was on building an infrastructure for the performance of surgical multicenter, randomized controlled clinical trials with the inclusion of university and non-university hospitals. The education of clinicians with an interest in clinical research and the transfer of research ideas (as investigator initiated trials, IIT) were clear goals for this grant. The aim of this article is to evaluate the incentive measures by comparison of clinics with and without participation in CHIR-Net structures. Anationwide online survey included atotal of 475 heads of surgical departments of whom 268 worked in hospitals with participation in CHIR-Net structures and 207 at hospitals without. They were asked to answer 20questions in the following categories: education and activities in clinical trials, number of publications and participation in grant applications at the BMBF and/or German Research Foundation (DFG). The evaluation of the survey was performed according to apriori defined criteria. The response rate was 23.4% and 68CHIR-Net hospitals and 43non-CHIR-Net hospitals participated in the survey. The comparison of the results between the hospitals showed that the network significantly contributed to improvement of the study culture, especially in the areas of education in clinical research, infrastructure for clinical trials, study activity, grant applications and publication rates. The hospitals that participate in CHIR-Net structures were superior to hospitals that do not participate in CHIR-Net structures regarding study activity, infrastructure for clinical trials, study-specific education of clinicians, grant applications and publication rates. The goal of the grant was achieved and the funding led to manifold, long-term cooperation and aclear improvement of the study culture in surgery.