Clinical Trial Agreement Switzerland

A request for clinical studies began with the approval of the Ethics Committee and was followed by the centralized national review (Swissmedic or Swiss Therapeutic Products Agency, as “Agency”) in a two-step sequential process. Although the objectives of the Agency`s ethics committee and audits were fundamentally different, the evaluation was dupliced and sometimes led to conflicting comments. Keywords: clinical research, clinical study unit, value, quality In the common goal of promoting quality at all stages of a research project, CTUs act as multidisciplinary study centres and offer specific services at each stage of the study (see figure 1). These include creating relevant research questions, using robust methods, collecting high-quality data, improving recruitment patterns and transparently disseminating study results. To ensure quality services, all CTU employees – in addition to their expertise in their respective fields – receive ongoing training to the latest standards and requirements from regulators, funders and other institutions in the field of clinical research. Ten years ago, the Swiss National Fund (SNF) laid the groundwork for the creation of CTUs in the five Swiss university hospitals (Basel, Bern, Geneva, Lausanne and Zurich) and at the Saint-Gall cantonal hospital, with the aim of improving the quality of scientific clinical research projects in Switzerland. In 2016, the Cantonal Hospital Network of the Ospedaliero Cantonale Duck and its CTU in Ticino joined the network as an associate member of the Italian-speaking clinical research community. It is the largest national provider of services and education for the university research group and employs more than 140 people. CTUs cooperate not only with national donors, supervisory authorities and policy makers, but also with international initiatives such as the European Patients` Academy on Therapeutic Innovation (EUPATI) or the European Clinical Research Infrastructure Network (ECRIN) [22, 25].

While feedback from stakeholders actively participating in CTUs has been very positive, praise is not a standardized measure of the real impact of CTU services on research quality. It has been shown that the lack of common understanding and agreement on the cornerstones that constitute good clinical research and a similar lack of practical guidelines on how to increase their value are hampering efforts within the academic system [32].

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