Open-label trials and drug registration: a European regulator’s view
نویسندگان
چکیده
منابع مشابه
Open Clinical Trial Data for All? A View from Regulators
In this issue of PLoS Medicine, Doshi and colleagues argue that the full clinical trial reports of authorized drugs should be made publicly available to enable independent re-analysis of drugs’ benefits and risks [1]. We offer comments on their call for openness from a European Union drug regulatory perspective. For the purpose of this discussion, we consider ‘‘clinical study reports’’ to compr...
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ژورنال
عنوان ژورنال: Journal of Thrombosis and Haemostasis
سال: 2008
ISSN: 1538-7933,1538-7836
DOI: 10.1111/j.1538-7836.2008.02835.x