کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
8757542 1596409 2018 9 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis
ترجمه فارسی عنوان
ارزیابی ریسک مزایای دوره ای با استفاده از تجزیه و تحلیل پذیری چند معیاره تصادفی بیزی
کلمات کلیدی
آزمایشات بالینی، ارزیابی ریسک سودمند ساختاری، گزارش ارزیابی مزایای دوره ای، متا آنالیز بیزی. تجزیه و تحلیل پذیری چند معیاره تصادفی، تجزیه و تحلیل تصمیم چند معیاره،
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی پزشکی و دندانپزشکی (عمومی)
چکیده انگلیسی
Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER) through the product's lifecycle. In this paper, we propose a general statistical framework for periodic benefit-risk assessment, in which Bayesian meta-analysis and stochastic multi-criteria acceptability analysis (SMAA) will be combined to synthesize the accumulating evidence. The proposed approach allows us to compare the acceptability of different drugs dynamically and effectively and accounts for the uncertainty of clinical measurements and imprecise or incomplete preference information of decision makers. We apply our approaches to two real examples in a post-hoc way for illustration purpose. The proposed method may easily be modified for other pre and post market settings, and thus be an important complement to the current structured benefit-risk assessment (sBRA) framework to improve the transparent and consistency of the decision-making process.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Contemporary Clinical Trials - Volume 67, April 2018, Pages 100-108
نویسندگان
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