NETWORK OF PEDIATRIC PHARMACOLOGY RESEARCH UNITS

儿科药物试验是必要的，但很难进行。然而，哥伦布市儿童医院通过提供必要的资源来克服与此类研究相关的伦理、财务和实际问题，成功地完成了数百项试验。可用的资源包括：a)积极的临床药理学和临床药剂科，b)儿科临床研究中心，c)儿科药理研究单位，d)大学综合临床研究中心，e)从事药物研究的有良好记录的基础和临床研究人员，f)大型儿科培训计划，g)支持性行政和科学人员和结构，h)具有代表性的大型儿科研究人群，以及i)尖端尖端技术。资源位于设计良好的研究空间和三级护理临床设施中，拥有出色的社区、医院和学术支持。我们提出了一项计划，通过继续作为扩大的NICHD儿科药理学研究“网络”的成员，在我们过去PPRU成功的基础上再接再厉。哥伦布PPRU将继续为联邦、制药和其他实体提供培训和资源，以规划、开展和分析儿科药物研究。儿科生物利用度、制剂、药物代谢、药代动力学(PK)、药效学(PD)、安全性和有效性研究都将进行。PPRU网络的目标是增加FDA批准用于儿童的药物的数量和种类。最终目标是为所有药物贴上标签以便在婴儿和儿童中适当使用提供必要的数据。对现有资源、PPRU以前的经验以及临床试验和培训活动进行了审查，以说明PPRU如何保证朝着这一目标快速取得进展。所进行的研究将与NICHD的使命以及从业者及其儿科患者的需求保持一致。给出了一个建议由该网络完成的止痛/退热试验的具体例子，以说明该PPRU有能力招募赞助商，设计研究，吸收PPRU网络成员的独特优势，并最大限度地发挥所产生结果的科学价值。可用的资源和申请者在各种儿科人群中进行儿科试验的已被证明的能力都为NICHD提供了机会，使其能够利用其在哥伦布PPRU的投资。这将加快儿科药物开发的步伐，增加受过培训的儿科药剂师的数量，并提高儿科药理学研究的数量和质量。

Pediatric drug trials are needed but are difficult to perform. Yet, Children's Hospital, Columbus has successfully completed hundreds of trials by providing the resources necessary to overcome the ethical, financial, and practical problems associated with such studies. Resources which are available include: a) active Clinical Pharmacology and Clinical Pharmacy Divisions, b) a Pediatric Clinical Study Center (P-CSC), c) a Pediatric Pharmacology Research Unit (PPRU), d) a university General Clinical Research Center (GCRC), e) basic and clinical investigators with proven track records conducting pharmaceutical research, f) a large pediatric training program, g) a supportive administrative and scientific staff and structure, h) large, representative pediatric study populations, and i) sophisticated state-of-the-art technology. Resources are located in well-designed research space and tertiary-care clinical facilities with excellent community, hospital, and academic support. A plan is proposed to build on our past PPRU success by continuing as a member of an expanded NICHD pediatric pharmacology research "Network". The Columbus PPRU would continue to provide training and serve as a resource to federal, pharmaceutical, and other entities for the planning, conduct, and analysis of pediatric drug studies. Pediatric bioavailability, formulations, drug metabolism, pharmacokinetic (PK), pharmacodynamic (PD), safety and efficacy studies would all be performed. The PPRU Network objective is to increase the number and variety of medications that are FDA-approved for use in children. The ultimate goal is to provide the data necessary for all drugs to be labeled for appropriate use in infants and children. Available resources, previous PPRU experience, as well as clinical trial and training activities are reviewed to illustrate how this PPRU would guarantee rapid progress toward this objective. Studies performed would be consistent with the mission of the NICHD and the needs of practitioners and their pediatric patients. A specific example is given of an analgesic/antipyretic trial proposed for completion by the Network to illustrate the ability of this PPRU to recruit sponsors, to design studies, to incorporate the unique strengths of individual PPRU Network members, and to maximize the scientific value of the results produced. The resources available and the applicant's proven ability to conduct pediatric trials in a variety of pediatric populations both provide the NICHD the opportunity to "leverage" its investment in the Columbus PPRU. This would enhance the pace of pediatric drug development, increase the number of trained pediatric pharmacologists available, and improve both the amount and quality of pediatric pharmacology research produced.