CORE--BIOSTATISTICAL AND CLINICAL SUPPORT

核心——生物统计和临床支持

• 批准号: 5210089
• 负责人: ROBERT J. GENCO
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5210089
• 关键词: biomedical facility; diagnosis design /evaluation; disease /disorder model; human subject; patient /disease registry; statistics /biometry; training

We propose to Support Core to efficiently coordinate both fiscal and human resources, as well as to optimize utilization of equipment and facilities for Center research. The Support Core has three sections: A) Administrative; B) Biostatistics; and C) Clinical, and will be under the general direction of Dr. Robert J. Genco. Dr. Sara Grossi will serve as Co-Director of the Clinical support section, and Dr. Gary Koch will be the statistical consultant for the Biostatistics section. The purpose of the Administrative support section is to provide scientific leadership, managerial, and clerical support for the Periodontal Disease Research Center. Preparation, internal review, and tracking of manuscripts will be carried out with the assistance of the Administrative support section staff. They will also schedule, provide minutes of meetings of the Internal Advisory Committee and Center staff at which consensus on protocols and publications is achieved. The Administrative support section will be responsible for interactions of the Center with the University, granting agencies, and other institutions. It will also aid in the training and faculty development activities of the Center, as well as activities of the External Advisory Committee. This Committee, which is comprised of a consultant from each project, will conduct reviews of the Center, including a full review in the third year, which will be used to strengthen and refocus ongoing projects. The Biostatistics support section will advise on all aspects of protocol design, data management, and data analysis in which statistical methods and computer recordings or analysis is involved. Our Biometrics Group has participated effectively in clinical periodontal studies and related laboratory studies requiring data capture and management, and computer- assisted statistical analysis of large data bases generated by Center scientists. The Clinical support section will provide overall resources and facilities for human clinical studies including (1) training and calibration of examiners; (2) assistance in protocol design; (3) clinical operations manual preparation; (4) quality control of measurements during studies; (5) coordination of human experimentation committee review; (6) recruitment and maintenance of an active patient base of adults (Prospective Study Group), juveniles (LJP Registry), and other groups of subjects or controls as needed; (7) screening patients for studies based upon inclusion/exclusion criteria; (8) implementing and monitoring compliance with clinical protocols; (9) patient record management including ensuring confidentiality; and (10) implementing animal model studies. The Clinical support section personnel will also plan and coordinate patient dental and medical treatments not directly related to protocol procedures, but necessary for full management of patients in the clinical studies. Further, the Clinical support section will aid in developing and refining new diagnostic, clinical and radiographic measurements technologies. The Clinical support section will assist in the clinical aspects of all Center projects supported by this grant, the University, or other sources.

我们建议支持核心有效协调财政和 人力资源，以及设备和设备的优化利用 中心研究设施。 支持核心分为三个部分：A) 行政; B）生物统计学； C) 临床，并将根据 Robert J. Genco 博士的总体指导。 Sara Grossi 博士将担任 临床支持部门联合主任和 Gary Koch 博士将担任 生物统计学部分的统计顾问。 行政支持部分的目的是提供 科学领导、管理和文书支持 牙周病研究中心。 准备、内部审查和 稿件追踪将在以下机构的协助下进行： 行政支持科人员。 他们还将安排、提供 内部咨询委员会和中心工作人员的会议记录 就议定书和出版物达成共识。 这 行政支持部门将负责以下部门的互动 该中心与大学、资助机构和其他 机构。 它还将有助于培训和师资发展 中心的活动以及外部咨询的活动 委员会。 该委员会由来自各方的一名顾问组成 项目，将对中心进行审查，包括对 第三年，将用于加强和重新集中正在进行的 项目。 生物统计支持部分将就方案的各个方面提供建议 设计、数据管理和数据分析，其中统计方法 并涉及计算机记录或分析。 我们的生物识别团队 有效参与临床牙周研究及相关研究 实验室研究需要数据采集和管理，以及计算机 中心生成的大数据库辅助统计分析 科学家。 临床支持部分将提供整体资源和 人体临床研究设施，包括 (1) 培训和 检验员校准； (2) 协助协议设计； (三)临床 操作手册的编制； (4)测量过程中的质量控制 研究； （5）协调人体实验委员会的审查； (6) 招募和维持活跃的成人患者群 （前瞻性研究小组）、青少年（LJP 登记处）和其他群体 根据需要进行主题或控制； (7) 筛选患者进行研究 根据纳入/排除标准； (8) 实施和监测 遵守临床方案； (9)病案管理 包括确保机密性； (10)实施动物模型 研究。 临床支持部门人员还将计划和 协调与患者不直接相关的牙科和医疗治疗 协议程序，但对于患者的全面管理是必要的 临床研究。 此外，临床支持部分将帮助 开发和完善新的诊断、临床和放射学 测量技术。 临床支持部门将协助 这笔拨款支持的所有中心项目的临床方面， 大学或其他来源。