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

被引：24

作者：

De Boeck, K. ^{[1
]}

Bulteel, V. ^{[1
]}

Tiddens, H. ^{[2
]}

Wagner, T. ^{[3
]}

Fajac, I. ^{[4
]}

Conway, S. ^{[5
]}

Dufour, F. ^{[6
]}

Smyth, A. R. ^{[7
]}

Lee, T. ^{[5
]}

Sermet, I. ^{[4
]}

Kassai, B. ^{[8
,9
]}

Elborn, S. ^{[10
]}

机构：

[1] Univ Hosp Leuven, Leuven, Belgium

[2] Erasmus MC, Rotterdam, Netherlands

[3] Goethe Univ Frankfurt, Frankfurt, Germany

[4] Univ Paris 05, Paris, France

[5] St James Univ Hosp, Leeds LS9 7TF, W Yorkshire, England

[6] Vaincre Mucoviscidose, Paris, France

[7] Univ Nottingham, Div Child Hlth, Nottingham, England

[8] Hop Femme Mere Enfant HCL, Epicime, CIC 201, RIPPS, Lyon, France

[9] Univ Lyon, Lyon, France

[10] Belfast City Hosp, Belfast BT9 7AD, Antrim, North Ireland

来源：

JOURNAL OF CYSTIC FIBROSIS | 2011年 / 10卷

关键词：

Research network; Clinical trials; Cystic fibrosis; LONG-TERM AZITHROMYCIN; LUNG-FUNCTION; CHILDREN; GENOTYPE;

D O I：

10.1016/S1569-1993(11)60010-6

中图分类号：

R56 [呼吸系及胸部疾病];

学科分类号：

摘要：

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. (C) 2011 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

引用

页码：S67 / S74

页数：8

共 30 条

[11] Implementation of European standards of care for cystic fibrosis - provision of care [J].