The West Virginia Pediatric Clinical Trials Network

摘要 西弗吉尼亚州儿科临床试验网络(WVPCTN)将作为IDEA州的临床中心工作 PCTN将为阿巴拉契亚中部西弗吉尼亚州农村地区的个人提供临床试验机会 周边县包括在即时服务区内。WVPCTN将作为关键的准备工作 一个基于历史、身体、心理和财政负担的临床中心 慢性疾病状况以及导致这些状况的各种环境风险因素 在西弗吉尼亚州。WVPCTN作为一个成功的临床中心处于有利地位，因为它结合了 已经到位的各种结构和人力资源：主体确定、主体 招聘和学习表现。具体地说，WVPCTN将利用以下内容：用于主体识别 -西弗吉尼亚大学CTSI的综合数据存储库(包含200多万份患者记录)、大型新生儿和 我们出生分数和心脏项目的学龄队列(在研究计划中详细描述)，以及 来自西弗吉尼亚州围产期伙伴关系网络、残疾人卓越中心的目标队列 和西弗吉尼亚大学职业和环境研究系；用于学科招聘-西弗吉尼亚大学总校 和专科诊所，我们CTSI赞助的以实践为基础的研究网络，我们牙科的基础设施 COHRA拨款，基础设施从出生分数和心脏，以及现有的各种专业设置； 对于研究绩效-经验丰富的调查员队伍，一组受训调查员，以及资源 以及对西弗吉尼亚大学CTSI赞助的临床试验研究单位核心的监督。这些功能和资源， 以及全州强有力和持续的合作伙伴关系，以及与环境有关的多个 我们公民的条件，独特的地位，使我们既能在PCTN试验中取得成功，又能为 PCTN。WVPCTN将为全州儿科重点倡议的长期承诺增添一份力量 并受益于已经建立的全州范围的网络，部分是通过积极的IDEA国家机制。 因此，我们处于独特的地位，可以充分利用额外资金高效地建立基础设施，以 提供将影响西弗吉尼亚州儿童健康的尖端试验。

Abstract The West Virginia Pediatric Clinical Trials Network (WVPCTN) will work as a Clinical Center of the IDeA States PCTN to provide clinical trial access to individuals in the rural, central Appalachian state of West Virginia and surrounding counties included in the immediate service area. The WVPCTN will be critically poised to serve as a Clinical Center based on the historical, physical, psychosocial, and fiscal burdens brought about by a multitude of chronic disease conditions and a wide variety of environmental risk factors that contribute to those conditions in West Virginia. The WVPCTN is well positioned to be successful as a Clinical Center due to a combination of a variety of structural and human resources already in place that address: Subject Identification, Subject Recruitment and Study Performance. Specifically, the WVPCTN will utilize the following: for Subject Identification - the Integrated Data Repository of the WVU CTSI (containing over 2 million patient records), large neonatal and school age cohorts from our Birth Score and CARDIAC projects (described in detail in the Research Plan), and targeted cohorts from the West Virginia Perinatal Partnership Network, the Center of Excellence in Disabilities and the WVU Department of Occupational and Environmental Studies; for Subject Recruitment – WVU General and Specialty Clinics, our CTSI sponsored Practice Based Research Network, the infrastructure of our Dental COHRA grant, the infrastructure from Birth Score and CARDIAC, and a variety of specialized existing settings; for Study Performance – an experienced investigator pool, a group of mentee investigators, and the resources and oversight of the WVU CTSI sponsored Clinical Trials Research Unit core. These features and resources, together with strong and sustained partnerships throughout the state, and the multiple environmentally related conditions of our citizens, uniquely position us to both be successful at PCTN trials and propose new trials for the PCTN. The WVPCTN will add to a long standing commitment to pediatric focused initiatives across the state and benefit from statewide networks that have been established, in part through active IDeA State mechanisms. As such, we are uniquely positioned to fully leverage additional funds to efficiently establish the infrastructure to provide access to cutting edge trials which will impact the health of the children of West Virginia.