title: The role of Clinical Trial Units in investigator- and industry-initiated research projects.
abstract: Six multidisciplinary competence centres (Clinical Trial Units, CTUs) in Basel, Berne, Geneva, Lausanne, St. Gallen and Zurich provide professional support to clinical researchers in the planning, implementation, conduct and evaluation of clinical studies. Through their coordinated network, these units promote high-quality, nationally harmonised and internationally standardised clinical research conduct in Switzerland. We will describe why this network has been established, how it has been successful in stilling the growing need for clinical research support, which training and education opportunities it offers, and how it created national awareness for the still-existing hurdles towards clinical research excellence in Switzerland. Taking the CTU Basel as an example, we show that a considerable number (25%) of the studies submitted for regulatory approval in 2013 were supported by the CTU, decreasing the number of findings in ethics reviews by about one-third. We conclude that these achievements, together with a Swiss national funding model for clinical research, and improved national coordination, will be critical factors to successfully position Swiss clinical research at the international forefront.
authors.affiliation: Clinical Trial Unit, Department of Clinical Research, University Hospital and University of Basel, Switzerland.
authors.forename: Belinda
authors.initials: B
authors.lastname: von Niederhäusern
authors.affiliation: Clinical Trial Unit, Department of Clinical Research, University Hospital and University of Basel, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Fabbro
authors.affiliation: Clinical Trial Unit, Department of Clinical Research, University Hospital and University of Basel, Switzerland.
authors.forename: Christiane
authors.initials: C
authors.lastname: Pauli-Magnus
mesh_terms: D035843:Biomedical Research / Q000193:education / Q000458:organization & administration* / Q000592:standards; D057191:Capacity Building / Q000458:organization & administration; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D006801:Humans; D033183:Interdisciplinary Communication; D000068616:Professionalism; D012107:Research Design / Q000592:standards*; D012109:Research Support as Topic / Q000458:organization & administration; D013192:Staff Development / Q000458:organization & administration; D013557:Switzerland