Pediatric Pharmacology Research Unit

描述(由申请人提供)： 这是为克利夫兰儿科药理学研究单位(PPRU)继续提供资金的申请。我们的部队于1994年，也就是PPRU成立一年后首次获得资助，自那时以来，其供资水平是该网络中其他单位的一半至三分之二。尽管存在资金偏见，克利夫兰一直是该网络的活跃成员。在最初的四年中，我们参与了13个网络协议，贡献了298名患者。在过去的五年里，这种活动轨迹一直保持不变。我们在28个协议方面处于领先地位，总共参与了69项网络研究，招募了657多名儿童。我们还完成了由克利夫兰PPRU设计和协调的两项主要的多点研究，这些研究随后被药物的创新者采用，以支持SNDA的申请。为了支持PPRU正在进行的活动，我们举办了两个印刷研讨会，一个是关于儿童抗高血压药物的评估，另一个是关于儿童睡眠障碍的治疗，旨在为进一步的临床试验奠定基础。最后，我们是第一个提交给NIH的PPRU独家多站点R01申请的牵头站点。我们的续签申请详细说明了我们作为PPRU网络成员取得的成就，并概述了我们将研究基础扩大到几个新的治疗领域的计划。为了补充我们在药代动力学/药效学建模方面的专业知识，我们建议进行一项研究，以评估研究设计的新方法，这些方法应该会增加我们在儿科药物开发方面的努力。这些办法对于支持即将开展的针对《儿童最佳药品法》的PPRU倡议将是至关重要的。我们还将在儿童睡眠障碍领域为该网络带来一系列试验。我们还将介绍将药物遗传学方法整合到阐明儿童不良药物反应的新机制中的方法。最后，我们将讨论我们在儿科药理学研究方面的扩展培训计划。

DESCRIPTION (provided by applicant): This is an application for continuation of funding for the Cleveland Pediatric Pharmacology Research Unit (PPRU). Our unit was first funded in 1994, one year after the establishment of the PPRU and has been funded since then at a level one-half to two thirds that of the other units in the network. Despite this funding bias, Cleveland has been an active member of the Network. During the first four years we participated in 13 network protocols contributing 298 patients. The last five years have seen this trajectory in activity maintained. We have been the lead site on 28 protocols and participated overall in 69 network studies enrolling more than 657 children. We have also completed two major multisite studies designed and coordinated by the Cleveland PPRU that have subsequently been adopted by the drugs' innovators to support SNDA filings. In support of ongoing PPRU activities we have developed two print symposia, one dealing with the evaluation of antihypertensive agents in children and the other dealing with the treatment of sleep disorders in children, designed to set the stage for further clinical trials. Finally we are the lead site on the first PPRU-exclusive multisite R01 application submitted to NIH. Our renewal application both details our accomplishments as a member of the PPRU Network and outlines our plans to expand our research base into several new therapeutic areas. To compliment our demonstrated expertise in pharmacokinetic/ pharmacodynamic modeling we propose a study to evaluate new approaches to study design that should add parsimony to our efforts at pediatric drug development. These approaches will be essential in support of the upcoming PPRU initiatives in response to the Best Pharmaceuticals for Children Act. We will also bring to the network a series of trials in the area of pediatric sleep disorders. We will also present approaches to the integration of pharmacogenetic approaches into the elucidation of novel mechanisms of adverse drug reactions in children. Finally, we will discuss our expanded training program in pediatric pharmacology research.