کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5104867 1377455 2017 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
A Review of Patient-Reported Outcome Labeling in the United States (2011-2015)
ترجمه فارسی عنوان
تجدید نظر در نشانه های نتیجه گیری بیمار در ایالات متحده (2011-2015)
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی پزشکی و دندانپزشکی (عمومی)
چکیده انگلیسی

BackgroundA review of new drug approvals (NDAs) by the Food and Drug Administration (FDA) for 2006 to 2010 showed that 24.1% of new drugs had patient-reported outcome (PRO) labeling.ObjectivesTo review PRO labeling for NDAs for 2011 to 2015 and to compare key findings reported previously.MethodsA review of the FDA drug approval reports for NDAs was conducted using the FDA Web site to determine the number of NDAs for the period 2011 to 2015. For all identified NDAs, drug approval package and product labeling were reviewed to identify PRO end-point status and PRO labeling. NDAs for the period 2006 to 2015 were grouped by disease category as per the International Classification of Diseases, Tenth Revision. Data were summarized for all NDAs and for approvals in diseases that traditionally rely on PROs for evaluating treatment benefit (PRO-dependent). Results were compared with NDAs for the period 2006 to 2010.ResultsIn the period 2011 to 2015, 16.5% of the 182 NDAs had PRO labeling. For PRO-dependent NDAs, this figure was 46.9% and 46.0% for the period 2006 to 1010 and the period 2011 to 2015, respectively. Most of the PRO labeling for the period 2011 to 2015 was based on primary end points (76.7%). Almost all PRO labeling was for concepts proximal to the disease.ConclusionsThere is potential for increased PRO labeling, especially for drug approvals in diseases that traditionally rely on PROs for evaluating treatment benefit to satisfy regulatory needs. Less PRO labeling based on secondary end points may be indicative of drug manufacturers' reluctance to aid and enhance the value propositions of their products to all stakeholders, including patients.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Value in Health - Volume 20, Issue 3, March 2017, Pages 420-429
نویسندگان
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