BOSTON ORAL HEALTH CLINICAL RESOURCE CENTER

这项建议的目的是提高牙科临床的质量。 通过创建一个地区性的链接设施在美国进行研究 福赛斯牙科中心，哈佛大学牙科医学院，波士顿 大学和塔夫茨大学。该中心将提供各种 旨在满足他的目标的服务。教育目标将是 通过开设临床设计和实施课程来完成 牙科临床试验。这些课程将包括实验的元素 设计、统计分析并强调FDA下的实验行为 指导方针。将提供高级统计咨询以进行评估 实验设计，确保适当的实验对照，并提出 基于在统计部门内进行的研究的新分析建议 区域统计学家座谈会。主题获取将通过 有意愿的患者的广告和目录的密集节目 并有兴趣参加来自4个国家的临床试验 波士顿地区的牙科机构。沟通目标将是 通过福赛斯互联网节点实现。这个设施将提供所有 牙科调查人员访问特定的数据库，最初包括 口腔微生物的临床数据集和DNA序列。它还将 为电子邮件提供区域访问，并在世界各地访问 先进的互联网功能。正在进行的临床试验中的临床 核心中心将为有兴趣的个人提供机会获得 在进行临床试验方面有直接的实践经验。中心 将征集临床研究以扩大NIDR资助的相关性 商业产品的实验室研究、临床研究和直接 支持通过试点项目计划资助的临床研究。研究 将在严格的FDA指导下进行，以确保保密， 通过内部审计程序确保质量和诚信。进阶 实验室方法学将作为一项服务提供，以协助 进行临床试验。提供的第一个这样的技术 将“棋盘式”DNA探针分析用于检测或口服 微生物作为临床试验的一部分。临床先导试验计划 将由波士顿地区的调查人员申请 支持试点研究。提交的意见书将由一个 来自波士顿所有4家牙科机构的临床科学家 根据所分配的优先级。由外部审查成员组成的小组将 成立的目的是审查和提出关于以下活动的建议 临床核心中心。可用于临床研究的设施，请访问 福赛斯将包括一个有10把椅子的手术室，一个放射成像设施，等待 机房、数据分析设施、互联网连接和临床管理 办公室。

The objective of this proposal is to improve the quality of dental clinical research in the United States by creating a regional facility linking Forsyth Dental Center, Harvard School of Dental Medicine, Boston University and Tufts University. The center will provide a variety of services designed to meet his objective. The educational objective will be accomplished by offering courses in the design and conduct of clinical trials in dentistry. These courses will include elements of experimental design, statistical analysis, and emphasize experimental conduct under FDA guidelines. Advanced statistical consultation will be provided to evaluate experimental designs, ensure appropriate experimental controls and propose new analytical proposals based on studies conducted within a Statistical Colloquium of regional statisticians. Subject acquisition will be through an intensive program of advertisement and cataloging of patients willing and interested in participating in clinical trials from each of the 4 Boston area dental institutions. The communication objective will be achieved through the Forsyth internet node. This facility will provide all dental investigators access to specific data bases initially including clinical data sets and DNA sequences of oral microorganisms.. It will also provide regional access for electronic mail and access to worldwide advanced Internet functions. Ongoing clinical trials within the clinical core center will offer an opportunity for interested individuals to obtain direct practical experience in the conduct of clinical trials. The center will solicit clinical studies to expand the relevance of NIDR funded laboratory studies, clinical studies of commercial products and directly support clinical studies funded through a pilot project program. Studies will be conducted under strict FDA guidelines ensuring confidentiality, quality and integrity through internal audit procedures. Advanced laboratory methodology will be made available as a service to assist in the conduct of clinical trials. The first such technology to be made available will be the "checkerboard" DNA probe analysis for detection or oral microorganisms as part of clinical trials. A clinical pilot trials program will be initiated by which investigators of the Boston area may apply for support of pilot studies. Submissions will be reviewed by a panel of clinical scientists from all 4 Boston dental institutions and awarded according to priority assigned. A panel of external review members will be constituted to review and make recommendation concerning the activities of the clinical core center. Facilities available for clinical research at Forsyth will include a 10-chair operatory, a radiography facility, waiting room, data analysis facility, Internet linkage and clinical administration office.