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

Authors
Journal
Journal of Cystic Fibrosis
1569-1993
Publisher
Elsevier
Publication Date
Volume
10
Identifiers
DOI: 10.1016/s1569-1993(11)60010-6
Keywords
  • Workpackage 3. Coordination Of Clinical Research
Disciplines
  • Law
  • Medicine

Abstract

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.

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