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

K. de Boeck , V. Bulteel , H. Tiddens , T. Wagner , I. Fajac , S. Conway , F. Dufour , Ar. Smyth , T. Lee , I. Serment , Behrouz Kassai Koubai (1) , S. Elborn

1 Evaluation et modélisation des effets thérapeutiques

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

Domaines: Sciences du Vivant [q-bio]

K. de Boeck, V. Bulteel, H. Tiddens, T. Wagner, I. Fajac, et al.. Guideline on the design and conduct of cystic fibrosis clinical trials: The European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN). Journal of Cystic Fibrosis, 2011, 10, pp.S67-S74. ⟨10.1016/S1569-1993(11)60010-6⟩. ⟨hal-02299268⟩