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

• DOI: 10.1016/s1569-1993(11)60010-6
• Publication Date: 2011-06-24T12:17:54Z
• Authors: K. De Boeck; V. Bulteel; H. Tiddens; T. Wagner; I. Fajac; S. Conway; F. Dufour; A.R. Smyth; T. Lee; I. Sermet; B. Kassai; S. Elborn
• Keywords: EMC OR-01-54-02; Pulmonary and Respiratory Medicine; clinical trials; EMC NIHES-03-30-01; Clinical Trials as Topic; research network; Cystic Fibrosis; [SDV]Life Sciences [q-bio]; Research network; Cystic fibrosis; Cystic Fibrosis/therapy; Clinical Trials as Topic/standards; Cooperative Behavior; Societies; Medical/organization & administration; Cystic Fibrosis/Europe; 3. Good health; cystic fibrosis; [SDV] Life Sciences [q-bio]; Europe; 03 medical and health sciences; Clinical trials; 0302 clinical medicine; Humans; Pediatrics, Perinatology, and Child Health; Cooperative Behavior; Societies, Medical

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.