PEDIATRIC PHARMACOLOGY RESEARCH UNIT

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。该股于1994年9月，也就是国家卫生研究所建立PPRU网络一年后首次获得资助，自那时以来，资金仅为该网络中其他单位的一半。尽管存在资金偏见，但在过去的三年半里，克利夫兰PPRU一直是该网络的活跃成员，通过招募298名患者参与了13个网络协议。事实上，克利夫兰PPRU已经成为5个已完成或正在进行的网络协议的创新站点；3个得到了行业资金和赞助。我们单位还策划、赞助并举办了PPRU/欧洲发育生物学学会联合举办的题为“治疗的孤儿--30年后”的研讨会。会议记录将在不久的将来提交发表。在为我们的PPRU继续寻求资金的过程中，我们打算该单位继续与凯斯西储大学儿科药物研究中心保持密切关系。在过去的15年里，该中心参与了几乎每一种为婴儿和儿童标记的药物和疫苗的NDA前评估。克利夫兰PPRU不仅因为其人员和患者资源而做好了参与当前和未来网络协议的准备，而且，随着更新资金的请求，将为网络带来额外的资产。首先，这项申请将对PPRU和儿科临床试验的机构承诺提高到一个新的水平，建立了药物研究中心咨询委员会，由儿科研究部门副主席领导。该委员会将确保所有儿童健康专科都参与这项临床研究计划。我们的部门还通过与Drusano博士和他的团队的合作，极大地扩展了IS的药代动力学和建模能力，并通过将我们的PPRU生物统计/药物动力学核心合并为儿科部门内的一个新的临床流行病学部门，极大地扩展了我们的数据管理和分析能力。最后，通过纳入的研究建议，我们打算建立一个基础，进一步将网络的能力扩展到分子药物流行病学、药代动力学/药效学建模、涉及新分子实体发现的转化研究及其对婴儿和儿童的临床应用以及药物遗传学与功能基因组学的接口等领域。所有这些技术都将对婴儿和儿童的儿科治疗和药物标签的未来至关重要。

This is an application for continuation of funding for the Cleveland Pediatric Pharmacology Research Unit (PPRU). The unit was first funded in September 1994, one year after the establishment of the PPRU Network by NIH and has been funded since that time at only one half the level of the other units in the Network. Despite this funding bias, the Cleveland PPRU has been an active member of the Network for the past 3 1/2 years, participating in 13 network protocols by enrolling 298 patients. In fact, the Cleveland PPRU has been the innovating site for 5 of the completed or ongoing network protocols; 3 with industry funding and sponsorship. Our unit also planned, obtained sponsorship and held the joint PPRU/European Society of Developmental Biology Symposium entitled "The Therapeutic Orphan - 30 Years Later." The proceedings are due to be submitted for publication in the near future. In seeking continued funding for our PPRU, we intend that the unit continue its intimate relationship with the Center for Drug Research of the Department of Pediatrics at Case Western Reserve University. This Center has been involved in the pre NDA evaluation of virtually every drug and vaccine labeled for infants and children in the past 15 years. The Cleveland PPRU is not only prepared because of its personnel and patient resources to participate in the current and future network protocols, but, with this request for renewed funding will bring additional assets to the Network. First, this application brings a new level of institutional commitment to the PPRU and pediatric clinical trials with the establishment of the Center for Drug Research Advisory Board under the leadership of the Department of Pediatrics Vice-Chair for Research. This Board will ensure participation of all of the child health specialties in this clinical research program. Our unit has also greatly expanded both is pharmacokinetic and modeling capabilities through collaboration with Dr. Drusano and his group, and our data management and analysis capabilities through amalgamation of our PPRU Biostatistics/Pharmacokinetics Core into a new Division of Clinical Epidemiology within the Department of Pediatrics. Lastly, through the research proposals included, we intend to develop a foundation that will further extend the Network capabilities into the areas of molecular pharmcoepidemiology, pharmacokinetic/pharmacodynamic modeling, translational research involving new molecular entity discovery and its clinical application to infants and children as well as the interface of pharmacogenetics with functional genomics. All these technologies will be crucial to the future of pediatric therapeutics and drug labeling for infants and children.