RESEARCH UNITS ON PEDIATRIC PSYCHOPHARMACOLOGY--AUTISM

合同的目的是1）建立合格的临床 研究单位，通过建立现有的研究资源， 主办机构，并结合必要的专门知识， 临床药理学和儿童精神病学， 研究精神科药物安全性及效用的资源 药物治疗可以迅速和成本效益的方式进行; 以及2）资助特定公共卫生研究项目 特别是在自闭症和其他 广泛性发育障碍，将在这些单位进行。 这些单元与已经获得资金的RUP一起将作为一个 研究中心网络，并进行高优先级临床 在不同年龄段的儿童中进行研究， 儿科精神药理学方面，包括（但不限于 至）：剂量范围、给药方案、药代动力学、一般安全性 概况、功效和有效性，以及对认知的影响， 行为和发展。 建立临床研究单位， 安全性、有效性、药代动力学和药效学 精神药物可以在儿童中进行研究， 青少年，一般来说，和患有自闭症的患者， 尤其是其他广泛性发育障碍。 在每个研究单位进行至少2项研究（其中 一项为临床疗效试验，另一项为 药代动力学和/或药效学剂量探索研究或 初步疗效和耐受性研究）， 合同 此外，如果行使两年的选择权， 至少另外两个类似的研究（即，一项疗效试验和一项 药代动力学和/或药效学剂量探索研究）应 进行。 为了刺激其他临床试验和研究的进行， 儿科精神药理学将通过其他机制资助 本合同（即，政府发起的赠款， 联邦机构、私人基金会和制药公司 公司）。

The purpose of the contract is to 1) establish qualified clinical research units that, by building of existing research resources at the host Institution and combining the necessary expertise in clinical pharmacology and child psychiatry, can become national resources where studies ont he safety and efficacy of psychotropic medications can be conducted in a prompt and cost effective manner; and 2) fund selected research projects of particular public health significance, in particular in the area of autism and other pervasive developmental disorders, to be conducted at these units. The units, together with the already funded RUPPs will work as a network of research sites and conduct high priority clinical studies in various pediatric ages, conducting research on various aspects of pediatric psychopharmacology, including (but not limited to): dose ranges, dosing regimen, pharmacokinetics, general safety profile, efficacy and effectiveness, and effects on cognition, behavior and development. To establish research units of where clinical studies on the safety, efficacy, pharmacokinetics and pharmacodynamics of psychotropic medications can be investigated in children and adolescents, in general, and in patients suffering from autism and other pervasive developmental disorders in particular. To conduct a minimum of 2 studies at each research unit (of which one shall be a clinical efficacy trial and the other a pharmacokinetic and/or pharmacodynamic dose finding study or a pilot efficacy and tolerability study) during the 3 years of the contract. In addition, if the two year option is exercised, at least another two similar studies (i.e., one efficacy trial and one pharmacokinetic and/or pharmacodynamic dose finding study) shall be conducted. To spur the conduct of other clinical trials and studies in pediatric psychopharmacology to be funded through mechanisms other than this contract (i.e., investigator-initiated grants from federal agencies, private foundations, and pharmaceutical companies).