کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8449420 | 1547623 | 2007 | 4 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
How can biomarkers become surrogate endpoints?
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کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
تحقیقات سرطان
پیش نمایش صفحه اول مقاله
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چکیده انگلیسی
As there is an urgent need for careful planning of development schemes for new classes of molecularly targeted anticancer therapies, the use of biomarkers as surrogate endpoints in therapeutic trials was discussed by BDA delegates, representing the pharmaceutical industry, regulatory agencies, academia, and patient advocacy groups in a breakout session. The aim was the clarification of the role of surrogates in the conduct of clinical trials that serve as a basis for drug licensure or registration, especially in the setting of accelerated or conditional approval. The discussions focused on three questions: (a) how to validate biomarkers, (b) how biomarkers might be used as surrogate endpoints in small clinical trials, and (c) how a biomarker might be used in studies of agents other than the one for which it was validated. The deliberations of the group are discussed herein.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Journal of Cancer Supplements - Volume 5, Issue 9, December 2007, Pages 37-40
Journal: European Journal of Cancer Supplements - Volume 5, Issue 9, December 2007, Pages 37-40
نویسندگان
B. Berns, P. Démolis, M.E. Scheulen,