کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2579475 | 1130052 | 2008 | 4 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Non-interventional Research and Usual Care: Definition, Regulatory Aspects, Difficulties and Recommendations
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
فارماکولوژی، سم شناسی و اقلام دارویی (عمومی)
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
Non-interventional research is an essential approach to gathering data in different situations and it often complements other research methodologies, such as biomedical research and research aimed at evaluating usual care. Yet the legislative framework for this type of research is nonexistent, and this void poses a number of problems for non-interventional researchers, including an absence of any guarantee of quality and therefore of reliability, a limited recognition of the research beyond our borders, cumbersome administrative procedures, and a lack of visibility. In light of the growing demand for data, particularly in post marketing authorisation for drugs, which largely relies on non-interventional methods, the Round Table participants have issued a set of proposals for a future legislative framework for this type of research.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Thérapie - Volume 63, Issue 2, MarchâApril 2008, Pages 103-106
Journal: Thérapie - Volume 63, Issue 2, MarchâApril 2008, Pages 103-106
نویسندگان
François Lemaire, Sophie Ravoire, Danielle Golinelli,