General Clinical Research Center

该临床中心将为962名SCO患者提供最先进的临床研究活动支持 在圣克里斯托弗儿童医院（SCHC），托马斯杰斐逊大学医院（TJUH），科赛尔 儿童医院（KCH）和杜邦儿童医院（DCH）。其中三个研究中心（SCHC、KCH、TJUH） 目前是玛丽安安德森综合（MAC）镰状细胞中心的一部分，目前领导 由综合中心赞助的几项I/II/III期中心间研究的入组，还 在丹皮尔博士和罗克斯坦女士的指导下，通过MAC中心的临床核心。PI中心 和中心首席临床协调员在圣克里斯托弗医院都是由该协会认证 临床研究专业人员（分别为临床试验研究者和CRA认证）， 多年来成功协调和监督各中心的研究活动 网站.拟议的网络临床试验解决了SCO患者临床护理中的重要问题。第一 这项研究是头痛管理的第四阶段，将建立在描述性和流行病学数据的基础上， 作为综合中心网络的C-data项目的一部分进行收集。本研究提出了4个月的时间 安慰剂对照RCT的预防性治疗（阿米替林伴或不伴CBT培训），7- 17岁，在前3个月内每月头痛2次，而一项伴随研究将评估 阿米替林或双丙戊酸钠ER在减少复发性头痛天数方面的有效性， 一项为期4个月的双盲、平行治疗、安慰剂对照试验，研究对象为患有<$2例偏头痛的成人， 月第二项临床试验将检查两种替代吗啡PCA给药方案在 与标准PCA疗法相比。它还将确定吗啡的变异是否- 在遗传药理学确定的吗啡药效学中，或受试者的心理社会 “演员，改变各种PCA方案的功效。还提出了一个成果核心， 开发各种结局指标和描述性临床信息，以支持适当的， 开展镰状细胞相关疼痛治疗的高质量临床试验。 这些研究的表现将促进镰状细胞相关疼痛及其 后果他们的结果将刺激镰状疼痛的创新临床试验的发展。

This Clinical Center will provide supportfor state-of-the-art clinical research activities for 962 SCO patients at St. Christopher's Hospital for Children (SCHC), Thomas Jefferson University Hospital (TJUH), Kosair Children's Hospital (KCH), and duPont Children's Hospital (DCH). Three of these sites (SCHC, KCH, TJUH) are currently part of the Marian Anderson Comprehensive (MAC) Sickle Cell Center and currently lead enrollment in several of the phase l/ll/lll Inter-Center studies sponsored by the Comprehensive Centers, also under the direction of Dr Dampier and Ms Rockstein through the MAC Center's Clinical Core. The Center PI and Center Chief Clinical coordinator at St. Christopher's Hospital are both credentialed by the Association of Clinical Research Professionals (Clinical Trial Investigator, and CRA certifications respectively) and have a several year record of successful coordination and supervision of research activities at the various Center sites. The proposed network clinical trials address important issues in clinical care of SCO patients. The first study is a phase IV of headache management that will build on descriptive and epidemiologic data being gather as part of the C-data project of the Comprehensive Center's Network. This study proposes a 4 month placebo controlled RCT of prophylactic therapy (amitryptline with or without CBT training) in children aged 7- 17 years with ¿ 2 headaches per month in the preceding 3 months, while a companion study will evaluate the effectiveness of amitriptyline or divalproex ER in reducing the number of days of recurrent headaches in a 4 month double blind, parallel treatment, placebo-controlled trial of adults with ¿ 2 migraine headaches per month. The second clinical trial will examine the efficacy of two alternative morphine PCA dosing regimens in comparison to a standard PCA therapy. It will also determine whether variations in morphine pharrnaco- cinetics, in morphine pharmacodynamics as determined by pharmacogenetics, or subject psychosocial 'actors, alter the efficacy of the various PCA regimens. An Outcomes Core is also proposed which will focus on developing a variety of outcome measures and descriptive clinical information to,support the appropriate , conduct of high quality clinical trials of therapies for sickle cell-related pain. The performance of these studies will advance the clinical understanding of sickle cell-related pain and its consequences. Their results will stimulate the development of innovative clinical trials of sickle pain.