Obstetrical Pharmacology Research Network - Data Coordination and Analyses Center

产科药理学研究网络-数据协调和分析中心

• 批准号: 8262528
• 负责人: Linda Morris Brown
• 金额: $ 11.98万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-01 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8262528
• 关键词: Address; Adult; Animal Experimentation; Animals; Attention; Behavioral; California; Childhood; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Collection; Communication; Computer software; Congresses; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Element; Data Quality; Data Set; Development; Discipline of obstetrics; Doctor of Pharmacy; Doctor of Philosophy; Drug Interactions; Drug Kinetics; Drug Labeling; Drug usage; Ensure; Epidemiology; Fetal Tissues; Funding; Human Resources; Institutional Review Boards; International; Internet; Kinetics; Leadership; Logistics; Maintenance; Manuals; Maternal and Child Health; Methods; Modeling; Monitor; National Institute of Child Health and Human Development; Online Systems; Outcome; Patients; Persons; Pharmaceutical Preparations; Pharmacodynamics; Pharmacology; Phase I Clinical Trials; Placenta; Population; Pregnancy; Preparation; Procedures; Protocols documentation; Publications; Quality Control; Reporting; Research; Research Design; Research Personnel; Secure; Shipping; Ships; Site; Specific qualifier value; Statistical Models; System; Teleconferences; Teratology; Tissue Sample; Tissues; Toxicology; Training; Translating; Umbilical Cord Blood; United States Food and Drug Administration; Work; Writing; base; clinical practice; clinical research site; data management; design; electronic data; experience; exposed human population; fetal; meetings; model development; operation; pharmacodynamic model; pharmacokinetic model; preclinical study; protocol development; quality assurance; repository; reproductive; translational medicine

DESCRIPTION (provided by applicant): RTI International (RTI) proposes to establish the Data Coordinating and Analysis Center (DCAC) for the Obstetrical Pharmacology Research Network (OPRU). RTI's 31 years of experience serving as DCAC for over 25 multi-site clinical, epidemiologic, and behavioral studies, many in the field of maternal and child health, enable us to recognize and address the various responsibilities that must be undertaken by a DCAC to successfully meet the ever-changing needs of a multi-site study. The OPRU DCAC has several unique requirements: (1) the DCAC will integrate into an operational Network with multiple ongoing protocols, (2) the biospecimens collected include unusual tissues such as placenta and cord blood, and (3) some data may be submitted to the FDA in support of drug labeling, which has implications for quality assurance and control in the protocols. Of particular note, the research involves the opportunity to advance the field of pharmacokinetic and pharmacodynamic modeling. Consequently, we propose key persons with experience in DCAC projects, as well as statistical modeling and animal and clinical research. We propose Dr. Rick Williams as PI (DCAC management and statistical modeling) and Co-Investigators Drs. Timothy Fennell (animal toxicology) and Claude Hughes (clinical trial and translational medicine) from RTI and Dr. Edmund Capparelli (pediatric pharmacokinetic analysis) at the U of California, San Diego. Other responsibilities for the DCAC include, but are not limited to: (1) participating in protocol development; (2) developing and implementing a study-wide communications network; (3) providing data collection and management systems that are responsive to the emerging needs of the study; (4) supporting the logistics of the study as needed; (5) assisting in training site personnel in standard study procedures; (6) assisting in developing and implementing quality control and quality assurance procedures; (7) supporting the collection, shipping, and tracking of biospecimens; (8) providing biostatistical and data management leadership; (9) producing both routine and ad hoc reports that meet the needs of the Research Sites, the Steering Committee, and the Data Safety and Monitoring Board; and (10) helping to disseminate the results of the study through publications and presentations within the context of a coordinated dissemination plan. As the demands of the Network change, we will be able to supplement our base staff with needed expertise from our large staff with varied backgrounds that address the anticipated needs of the study. RTI's office near to NICHD in Rockville, MD, provides meeting space as needed for interaction and local support for Steering Committee meetings.

描述（由申请人提供）：RTI国际（RTI）提议为产科药理学研究网络（OPRU）建立数据协调和分析中心（DCAC）。 RTI 拥有 31 年作为 DCAC 进行超过 25 项多中心临床、流行病学和行为研究的经验，其中许多研究涉及孕产妇和儿童健康领域，这使我们能够认识到并解决 DCAC 必须承担的各种责任，才能成功开展这项研究。满足多地点研究不断变化的需求。 OPRU DCAC 有几个独特的要求：(1) DCAC 将集成到具有多个正在进行的协议的运营网络中，(2) 收集的生物样本包括胎盘和脐带血等不寻常的组织，(3) 一些数据可能会提交给FDA 支持药物标签，这对协议中的质量保证和控制有影响。特别值得注意的是，该研究涉及推进药代动力学和药效学建模领域的机会。因此，我们推荐在 DCAC 项目、统计建模以及动物和临床研究方面具有经验的关键人物。我们建议 Rick Williams 博士担任 PI（DCAC 管理和统计建模）和联合研究员 Drs. RTI 的 Timothy Fennell（动物毒理学）和 Claude Hughes（临床试验和转化医学）以及加州大学圣地亚哥分校的 Edmund Capparelli 博士（儿科药代动力学分析）。 DCAC的其他职责包括但不限于： (1) 参与协议开发； (2) 开发和实施覆盖研究范围的通信网络； (3) 提供响应研究新需求的数据收集和管理系统； (4) 根据需要支持研究的后勤工作； (5) 协助对现场人员进行标准学习程序的培训； (6) 协助制定和实施质量控制和质量保证程序； （7）支持生物样本的采集、运输和追踪； (8) 提供生物统计和数据管理领导； (9) 制作满足研究中心、指导委员会以及数据安全和监测委员会需要的例行报告和临时报告； (10) 在协调传播计划的范围内通过出版物和演示文稿帮助传播研究结果。随着网络需求的变化，我们将能够从具有不同背景的大量员工中补充所需的专业知识，以满足研究的预期需求。 RTI 的办公室靠近马里兰州罗克维尔的 NICHD，可根据需要提供会议空间，以便为指导委员会会议提供互动和本地支持。