کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8591295 | 1565008 | 2017 | 21 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
TFOS DEWS II Clinical Trial Design Report
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
پزشکی و دندانپزشکی
چشم پزشکی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
The development of novel therapies for Dry Eye Disease (DED) is formidable, and relatively few treatments evaluated have been approved for marketing. In this report, the Subcommittee reviewed challenges in designing and conducting quality trials, with special reference to issues in trials in patients with DED and present the regulatory perspective on DED therapies. The Subcommittee reviewed the literature and while there are some observations about the possible reasons why so many trials have failed, there is no obvious single reason other than the lack of correlation between signs and symptoms in DED. Therefore the report advocates for conducting good quality studies, as described, going forward. A key recommendation for future studies is conduct consistent with Good Clinical Practice (GCP), including use of Good Manufacturing Practice (GMP) quality clinical trial material. The report also recommends that the design, treatments, and sample size be consistent with the investigational treatment, the objectives of the study, and the phase of development. Other recommendations for pivotal studies are a priori selection of the outcome measure, and an appropriate sample size.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: The Ocular Surface - Volume 15, Issue 3, July 2017, Pages 629-649
Journal: The Ocular Surface - Volume 15, Issue 3, July 2017, Pages 629-649
نویسندگان
Gary D. PhD, Penny MD, Stefano MD, PhD, Michael V.W. PhD, Joseph B. MD, Gary N. MD, Michael MD, Michael A. MD, Stefan MD, PhD, Craig PhD, MCOptom, Fiona PhD, MCOptom,