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如何在儿童中开展临床试验:教程。

How to Conduct Clinical Trials in Children: A Tutorial.

机构信息

Children's Mercy Kansas City, Kansas City, Missouri, USA.

University of Missouri-Kansas City School of Medicine, Kansas City, Missouri, USA.

出版信息

Clin Transl Sci. 2019 May;12(3):218-230. doi: 10.1111/cts.12615. Epub 2019 Mar 18.

Abstract

Despite a growing interest in, and commitment to, implementing pediatric clinical trials, approximately one in every five trials in children fails because of inappropriate study design, suboptimal experiment planning, or inadequate participant enrollment. This tutorial, presented from the perspectives of seasoned pediatric investigators, an experienced research coordinator, and an established pediatric clinical trials network, is designed to provide practical guidance for successfully implementing pediatric clinical trials at an academic center or another comparable institution.

摘要

尽管人们对开展儿科临床试验越来越感兴趣,并承诺要开展儿科临床试验,但仍有约五分之一的儿童临床试验因研究设计不当、实验规划不佳或参与者招募不足而失败。本教程由经验丰富的儿科研究人员、有经验的研究协调员和成熟的儿科临床试验网络从各自的角度呈现,旨在为在学术中心或其他类似机构成功开展儿科临床试验提供实用指南。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d293/6510379/b31ca7fb5ed3/CTS-12-218-g001.jpg

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