Prevention of Adult Caries Study (PACS) Data Coordinating Center

描述(由申请者提供)：数据协调中心将支持预防成人龋齿研究(PACS)的活动。PAC的主要目标是：1)测试与安慰剂涂层相比，洗必泰(10%w/v)牙科涂层可减少高危成人成人龋齿增加的假设；2)评估在四种牙科护理系统中使用洗必泰(10%w/v)涂层的成本和成本效益。数据协调中心将为PACS协议的制定、实施和成功完成提供行政、后勤和生物统计方面的支持。为了实现这一目标，DCC将：1)开发一个安全的研究专用网络门户，作为研究范围内交流、数据输入、文档和监测的主要资源；2)安排和进行研究人员在数据收集、数据输入和试验监测方面的持续培训和认证；3)监测诊所数据采集和数据输入的招募和及时性，并对所有研究数据执行质量保证(QA)程序；4)建立生成和分配随机分配任务和适当的研究治疗标签的方案；5)跟踪微生物标本的收集、转移和实验室分析，并对结果数据进行统计分析；6)每年进行现场访问，以监测诊所和实验室是否遵守良好临床实践指南；7)协调整体研究活动，包括安排会议和电话会议，记录和分发会议记录，并准备研究材料(例如，患者资格快速参考卡、患者信息手册)；8)向数据和安全监测委员会提供后勤支持，包括安排会议和电话会议，记录和分发会议记录，并报销费用和酬金；9)积极参与国家一级的试验委员会；10)向研究调查人员提供统计咨询和分析支持，包括制定和执行研究数据分析的全面计划，为FDA的新药申请编写支持文件，并支持编写研究批准的论文；11)开发和维护一个系统，以确定牙科保健利用和评估，并为每个临床中心的研究调查人员建立利用和成本数据收集和质量控制程序提供支持；12)开发有助于及时分析研究数据和编写和制作手稿的系统；13)准备和监督最终(“锁定”)研究数据的分发；和14)准备一个公共网页，以提供关于PACS的信息(以非专业术语)并张贴研究结果的摘要。

DESCRIPTION (provided by applicant): The Data Coordinating Center will support the activities of the Prevention of Adult Caries Study (PACS). PACS primary aims are 1) to test the hypothesis that chlorhexidine (10% w/v) dental coating, compared to a placebo coating, reduces adult caries increment in at-risk adults, and 2) to evaluate the cost and cost- effectiveness of using the chlorhexidine (10% w/v) coating in four dental care delivery systems. The Data Coordinating Center will provide administrative, logistical, and biostatistical support for the development, implementation, and successful completion of the PACS protocol. To accomplish this objective, the DCC will: 1) develop a secure study-specific Web portal to serve as a primary resource for study-wide communication, data entry, documentation, and monitoring; 2) arrange for and conduct ongoing training and certification of study staff with respect to data collection, data entry, and trial monitoring; 3) monitor recruitment and timeliness of data acquisition and data entry at the clinics and carry out quality assurance (QA) procedures on all study data; 4) establish a protocol for generating and allocating randomization assignments and appropriate labeling of study treatments; 5) track the collection, transfer, and laboratory analysis of microbiology specimens and conduct statistical analysis of the results data; 6) conduct yearly site visits to monitor clinic and laboratory compliance with Good Clinical Practice guidelines; 7) coordinate overall study activities, including scheduling meetings and conference calls, recording and distributing minutes, and preparing study materials (e.g., patient eligibility quick reference cards, patient information brochures); 8) provide logistical support to the Data and Safety Monitoring Board, including scheduling meetings and conference calls, recording and distributing minutes, and reimbursing for expenses and honoraria; 9) actively participate at the national level on trial-wide committees; 10) provide statistical consultation and analytic support to study investigators, including formulating and executing a comprehensive plan for analysis of study data, preparing supporting documentation for an FDA new drug application, and supporting preparation of study-approved papers; 11) develop and maintain a system to identify dental care utilization and valuations, and provide support to study investigators at each clinical center to establish utilization and cost data collection and quality control procedures; 12) develop systems that facilitate the timely analysis of study data and the preparation and production of manuscripts; 13) prepare and oversee distribution of the final ("locked") study data; and 14) prepare a public Web page to provide information (in lay terms) regarding PACS and to post synopses of study findings.