title: Guideline on the design and conduct of cystic fibrosis clinical trials: the European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN).
abstract: We describe the rationale for disease specific research networks in general as well as the aims and function of the European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) specifically. The ECFS-CTN was founded in 2009 with the aim of improving the quality and quantity of clinical research in the area of cystic fibrosis (CF) in Europe. A network of 18 clinical trial sites in 8 European countries was established according to uniform state-of-the-art quality criteria. To support the ECFS-CTN in the acquisition, planning and conduct of clinical trials, the network is equipped with a coordinating centre, steering and executive committees, and committees for protocol review, standardization, training and networking as well as a data safety monitoring board. A strong partnership with European CF patient parent organizations aims to increase awareness of the need for efficient clinical research and the participation of patients in clinical trials.
authors.affiliation: Department of Pediatrics, University Hospital of Leuven, Leuven, Belgium. christiane.deboeck@uzleuven.be
authors.forename: K
authors.initials: K
authors.lastname: De Boeck
authors.forename: V
authors.initials: V
authors.lastname: Bulteel
authors.forename: H
authors.initials: H
authors.lastname: Tiddens
authors.forename: T
authors.initials: T
authors.lastname: Wagner
authors.forename: I
authors.initials: I
authors.lastname: Fajac
authors.forename: S
authors.initials: S
authors.lastname: Conway
authors.forename: F
authors.initials: F
authors.lastname: Dufour
authors.forename: A R
authors.initials: AR
authors.lastname: Smyth
authors.forename: T
authors.initials: T
authors.lastname: Lee
authors.forename: I
authors.initials: I
authors.lastname: Sermet
authors.forename: B
authors.initials: B
authors.lastname: Kassai
authors.forename: S
authors.initials: S
authors.lastname: Elborn
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D003299:Cooperative Behavior; D003550:Cystic Fibrosis / Q000628:therapy*; D005060:Europe; D006801:Humans; D012955:Societies, Medical / Q000458:organization & administration* / Q000592:standards*