Guideline on the design and conduct of cystic fibrosis clinical trials: The European Cystic Fibrosis Society–Clinical Trials Network (ECFS-CTN)

• Published in: Journal of cystic fibrosis Vol. 10; pp. S67 - S74
• Main Authors: De Boeck, K, Bulteel, V, Tiddens, H, Wagner, T, Fajac, I, Conway, S, Dufour, F, Smyth, A.R, Lee, T, Sermet, I, Kassai, B, Elborn, S
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.06.2011
• Subjects: Clinical trials; Clinical Trials as Topic - methods; Clinical Trials as Topic - standards; Cooperative Behavior; Cystic fibrosis; Cystic Fibrosis - therapy; Europe; Humans; Pulmonary/Respiratory; Research network; Societies, Medical - organization & administration; Societies, Medical - standards; Europe; Clinical trials; Cystic fibrosis; Research network
• ISSN: 1569-1993; 1873-5010
• DOI: 10.1016/S1569-1993(11)60010-6

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.