کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5676777 | 1595225 | 2016 | 6 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
پزشکی و دندانپزشکی
پزشکی و دندانپزشکی (عمومی)
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چکیده انگلیسی
Pharmaceuticals approved in the United States are largely not known human carcinogens. However, cancer signals associated with pharmaceuticals may be hypothesized or arise after product approval. There are many study designs that can be used to evaluate cancer as an outcome in the postapproval setting. Because prospective systematic collection of cancer outcomes from a large number of individuals may be lengthy, expensive, and challenging, leveraging data from large existing databases are an integral approach. Such studies have the capability to evaluate the clinical experience of a large number of individuals, yet there are unique methodological challenges involved in their use to evaluate cancer outcomes. To discuss methodological challenges and potential solutions, the Food and Drug Administration and the National Cancer Institute convened a two-day public meeting in 2014. This commentary summarizes the most salient issues discussed at the meeting.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Annals of Epidemiology - Volume 26, Issue 11, November 2016, Pages 735-740
Journal: Annals of Epidemiology - Volume 26, Issue 11, November 2016, Pages 735-740
نویسندگان
Simone P. ScD, MSc, Donna R. PharmD, MSc, David J. MD, MPH, Andrew N. PhD, Jacqueline M. PhD, MS, Lynne MD, PhD, Mark PhD, Marie C. PhD, MPH, MPharm, Hui-Lee PhD, MSc, Rita PhD, MPH,