381 Registration of clinical trials in cystic fibrosis

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Clinical trials in cystic fibrosis.

In patients with cystic fibrosis (CF), clinical trials are of paramount importance. Here, the current status of drug development in CF is discussed and future directions highlighted. Methods for pre-clinical testing of drugs with potential activity in CF patients including relevant animal models are described. Study design options for phase II and phase III studies involving CF patients are pro...

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Delayed publication of clinical trials in cystic fibrosis☆

BACKGROUND When the publication of important trial data is delayed, or data are never published, this will prevent the proper practice of evidence based medicine through robust systematic reviews. Clinical trial registries allow researchers to interrogate the trial protocol and afford the opportunity to identify studies that have been completed and so determine the time lag between completion a...

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DNase trials in cystic fibrosis.

Cystic fibrosis (CF) is a disease with a high morbidity and mortality from pulmonary disease. Sputum from CF patients contains high levels of deoxyribonucleic acid (DNA), which contribute to its viscoelasticity. Recombinant deoxyribonuclease (rhDNase) has been developed and in vitro studies have showed reduction in the viscoelasticity of CF sputum. This article reviews the in vivo clinical tria...

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Novel Outcome Measures for Clinical Trials in Cystic Fibrosis

Cystic fibrosis (CF) is a common inherited condition caused by mutations in the gene encoding the CF transmembrane regulator protein. With increased understanding of the molecular mechanisms underlying CF and the development of new therapies there comes the need to develop new outcome measures to assess the disease, its progression and response to treatment. As there are limitations to the curr...

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Clinical Trials Registration

David P. Wilson, Sally M. Blower We agree with the thesis of Rosen et al. [1] that, despite initiatives such as the World Health Organization’s “3 by 5” program, rationing of HIV/AIDS antiretroviral therapy (ART) will be necessary in the majority of African countries. Diffi cult choices will need to be made, and choices will be constrained due to the limited health infrastructure and lack of qu...

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ژورنال

عنوان ژورنال: Journal of Cystic Fibrosis

سال: 2011

ISSN: 1569-1993

DOI: 10.1016/s1569-1993(11)60393-7