Warum Schwestern fliegen und Ärzte rotieren

Wyen, H.; Jakob, V.; Neudecker, Jens; Tenckhoff, Solveig; Seidel, Dörthe; Affüpper-Fink, M.; Knöll, Peter; Neugebauer, Edmund; Studiengruppe, und die ChirNet

doi:10.1007/s00104-013-2500-5

Cited by 3 publications

(1 citation statement)

References 11 publications

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“…Another drawback-at least in Germany-prohibiting the ideas of a national study society that conducts clinical trials is that the funding criteria allow a funding only at public health facilities, and an independent organization is exempt from this [33]. Initiatives such as the National Surgical Trial Network (CHIR-Net), which have been trying for many years with great commitment and enthusiasm to promote cooperation between the centres and to increase the study quality and funding application approval rate, have not yet been able to exploit their outstanding potential due to a lack of financial, personal and organizational support [34][35][36].…”

Section: Study Culture In Surgery In Germanymentioning

confidence: 99%

Failure of a Multi-Centric Clinical Trial Investigating Neoadjuvant Radio-Chemotherapy in Resectable Pancreatic Carcinoma (NEOPA-NCT01900327)—Which Lessons Are Learnt?

Tachezy,

Gebauer,

Yekebas

et al. 2023

Cancers

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Background: A significant number of clinical trials must be prematurely discontinued due to recruitment failure, and only a small fraction publish results and a failure analysis. Based on our experience on conducting the NEOPA trial on neoadjuvant radiochemotherapy for resectable and borderline resectable pancreatic carcinoma (NCT01900327—funded by the German Federal Ministry of Education and Research—BMBF), we performed an analysis of potential reasons for recruitment failure and general problems in conducting clinical trials in Germany. Methods: Systematic analysis of environmental factors, trial history, conducting and funding in the background of the published literature. Results: The recruitment failure was based on various study-specific conceptional and local environmental aspects and in peculiarities of the German surgical study culture. General reservations against a neo-adjuvant study concept combined with game changing scientific progresses during the long-lasting planning and funding phase have led to a reduced interest in the trial design and recruitment. Conclusions: Trial planning and conducting should be focused, professionalized and financed on a national basis. Individual interests must be subordinated to reach the goal to perform more relevant and successful clinical trials in Germany. Bureaucratic processes must be further fastened between a trial idea and the start of a study.

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Section: Study Culture In Surgery In Germanymentioning

confidence: 99%

Failure of a Multi-Centric Clinical Trial Investigating Neoadjuvant Radio-Chemotherapy in Resectable Pancreatic Carcinoma (NEOPA-NCT01900327)—Which Lessons Are Learnt?

Tachezy,

Gebauer,

Yekebas

et al. 2023

Cancers

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Nutzenbewertung von Medizinprodukten in der chirurgischen Praxis

Seidel

Braß

Sehnke

et al. 2014

Chirurg

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The market approval of medical devices in Germany does not yet require a benefit assessment. Thus, there is a lack of high quality studies that clearly prove the benefit of medical innovations. In the past, the Federal Joint Committee in Germany (G-BA) did not have the opportunity to adequately address this issue of lacking evidence. A law for the improvement of the care structure in the statutory health insurance offers the possibility for the G-BA to obtain evidence for the benefit of medical practice. With an integrated regulation for testing of medical devices the manufacturers have the option to apply for an assessment of new and established treatment methods and to provide scientific evidence for the benefit of medical devices as a requirement for inclusion in the catalogue of services of the statutory health insurance. However, this expanded scope of action is also a challenge for clinicians. The already existing problem of integrating multicenter clinical trials in the surgical routine will remain. The Surgical Study Network Germany (CHIR-Net) offers an ideal way to cope with the increased requirements on studies in the field of medical devices through established partnerships with methodological institutions and practitioners in clinical settings.

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Evaluation zur Infrastruktur für klinisch chirurgische Studien in Deutschland

Jakob

Neudecker

Tenckhoff

et al. 2018

Chirurg

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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 a clear improvement of the study culture in surgery.

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Warum Schwestern fliegen und Ärzte rotieren

Abstract: The CHIR-Net is able to develop a high quality study culture in Germany with its surgeon on rotation and flying study nurse program. In addition to the funding period by the BMBF, the continuance of the CHIR-Net should be a primary aim of further measures.

Cited by 3 publications

References 11 publications

Failure of a Multi-Centric Clinical Trial Investigating Neoadjuvant Radio-Chemotherapy in Resectable Pancreatic Carcinoma (NEOPA-NCT01900327)—Which Lessons Are Learnt?

Failure of a Multi-Centric Clinical Trial Investigating Neoadjuvant Radio-Chemotherapy in Resectable Pancreatic Carcinoma (NEOPA-NCT01900327)—Which Lessons Are Learnt?

Nutzenbewertung von Medizinprodukten in der chirurgischen Praxis

Evaluation zur Infrastruktur für klinisch chirurgische Studien in Deutschland

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