52 research outputs found

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

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    <p>Abstract</p> <p>Background</p> <p>Although 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.</p> <p>Mehods/Design</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>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.</p

    European Soil Data Centre 2.0: Soil data and knowledge in support of the EU policies

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    The European Soil Data Centre (ESDAC), hosted by the European Commission's Joint Research Centre (JRC), is the focal point for soil data, support to policy making and awareness raising for the European Union (EU). Established in 2006 to provide harmonised soil-related information for the EU Member States, and ESDAC currently hosts 88 datasets, 6000 maps, six atlases, 500 scientific publications, and a copious amount of soil-related material. Through its data repository publishing activity, ESDAC has licensed over 50,000 datasets during the past 15 years; 8500 of them in 2021 alone. It has published 140 monthly newsletters and is followed by more than 12,000 subscribed users, which receive regular updates. This article addresses the use, usability, and usefulness of ESDAC. About 75% of the ESDAC users come from academia and the research community while the remaining 25% includes public administration (at EU, national, regional, and local level) and the private sector. In addition, we provide some insights of the datasets evaluation and how they have been developed. The general ESDAC vision is to provide evidence underlying EU soil-relevant policies and to facilitate the access to relevant data for research. ESDAC is an integral part of the recently established European Union Soil Observatory (EUSO), with a target to have an even stronger role in supporting EU and regional policies. Highlights ESDAC is a central place from where to find European wide relevant soil data. ESDAC is an integral part of the EU Soil Observatory in creating data and knowledge for policy support. The ESDAC website shows a high volume of traffic; 10,000 of user licenses are granted per year. ESDAC key success: open access data policy, documentation, operational helpdesk and regular updates
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