Enhancing clinical trial development for pediatric kidney diseases.

Enhancing clinical trial development for pediatric kidney diseases.
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加强儿科肾脏疾病的临床试验开发。

DOI:
10.1038/pr.2017.180
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发表时间:
2017
期刊:
影响因子:
3.6
通讯作者:
Darsey,
Darsey,
中科院分区:
医学3区
文献类型:
--
作者:
Schnaper,HWilliam;Flynn,JosephT;Gross,Coleman;Cropp,AnneB;Dehmel,Bastian;Patel,LeahB;Greenbaum,LarryA;Houtsmuller,Elisabeth;Kaskel,Frederick;Moxey-Mims,Marva;Nowak,Karen;Silverstein,Douglas;Thompson,Aliza;Yao,Lynne;Darsey,

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参考文献

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在小型儿科亚专科(如儿科肾病)中开展临床试验受到儿科肾病学家临床需求和此类研究适用患者数量少的阻碍。成立美国儿科肾脏病学会治疗药物开发委员会(TDC)的目的是(1)确定对肾脏疾病儿童临床试验感兴趣和/或具有相关专业知识的各种利益相关者,以及(2)在所有各方之间建立更有效的合作伙伴关系,以制定成功的临床试验开发和执行策略。本文讨论了TDC的基本原理,结构和功能,实现其目标的进展状况,以及迄今为止获得的见解,可能对面临类似挑战的其他子专业有用。
The conduct of clinical trials in small pediatric subspecialties such as pediatric nephrology is hampered by both clinical demands on the pediatric nephrologist and the small number of appropriate patients available for such studies. The American Society of Pediatric Nephrology Therapeutics Development Committee (TDC) was established to (1) identify the various stakeholders with interests and/or expertise related to clinical trials in children with kidney disease and (2) develop more effective partnerships among all parties regarding strategies for successful clinical trial development and execution. This article discusses the rationale, structure, and function of the TDC, the status of progress toward its goals, and the insights gained to date that may be useful for other subspecialties that face similar challenges.
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期刊:
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