DESIGN AND ANALYSIS OF PERIODONTAL CLINICAL TRIALS

研究培训计划的目的是1）提供一个健全的 牙周膜设计与分析的理论基础 临床试验和2）开展人群基础病例对照 研究调查早发性乳腺癌的遗传流行病学 牙周炎这一目标将通过结构化的5-t=年实现 计划旨在提供暴露于流行病学和 生物统计学方法导致流行病学博士学位。 第一阶段的培训将包括5个组成部分： 流行病学，统计学和生物统计学;（2）独立研究 相关数据分析领域;（3） 将现有的统计学和流行病学方法扩展到 牙周病临床研究的设计与分析;（4） 牙周炎治疗效果的Meta分析 （5）参与教学， 生物统计学课程。 进入方案第二阶段的标准是： 圆满完成第（1）及（2）部分所述的课程， 第一阶段;（B）完成论文或专著，提交给 发表了关于临床研究中的方法学问题， 牙周病;（c）完成提交的文章 发表了第I阶段第4部分进行的荟萃分析; 及（d）取得博士学位。一般检查。 第二阶段的培训将包括执行一项人口- 基于病因学的病例对照研究，调查遗传成分 早发性牙周炎具体的研究假设 研究包括： H 01：HLA组织类型与早发性 牙周炎 H 02：HLA单倍型与早发性牙周炎基因分离 独立地。 拒绝这些假设将导致显着改善 我们对早发性牙周炎遗传因素的了解 并导致几个潜在的临床应用：（1）诊断，（2） 识别高危人群，（3）预防性治疗 牙周病的分类。 总之，拟议的培训计划将为Hujoel博士提供 在设计，分析和执行临床 审判这将为他提供发展成为一个 独立研究员，以获得研究经验， 流行病学和生物统计部的监督，以及 启动一个研究项目，论文。

The purpose of the research training plan is 1) to provide a sound theoretical foundation in the design and analysis of periodontal clinical trials and 2) to carry out a population bases case-control study investigating the genetic epidemiology of early onset periodontitis. This goal will be achieved by a structured 5-t=year program intended to provide exposure to epidemiological and biostatistical methodology leading to a PhD degree in Epidemiology. The training in Phase-I will consist of 5 components: (1) Course work in epidemiology, statistics, and biostatistics; (2) Independent study in the area of correlated data analysis; (3) Methodological research on extending existing statistical and epidemiological methods to problems of design and analysis of clinical studies of periodontal disease; (4) Meta-analysis of published studies on treatment efficacy for periodontal diseases; and (5) Participation in teaching an introductory biostatistics course in dental graduate students. The criteria for proceeding to Phase II of he programs are: (a) Satisfactory completion of courses outlined in Parts (1) and (2) of Phase I; (b) completion of an article or monograph to be submitted for publication addressing the methodologic issues in clinical studies of periodontal diseases; (c) completion of an article to be submitted for publication addressing the meta-analysis conducted in Part 4 of Phase I; and (d) Passing of Ph.D. general examinations. The training in Phase II will consist of the execution of a population- based etiologic case control study investigating the genetic component of early onset periodontitis. The specific research hypothesis of the studies are: H01: There is no association between HLA tissue types and early-onset periodontitis. H02: HLA haplotypes and the "early-onset periodontitis" gene segregate independently. Rejection of these hypotheses would lead to a significant improvement of our understanding of the genetic component of early onset periodontitis and lead to several potential clinical applications: (1) diagnosis, (2) identification of high risk individuals, (3) preventive treatment programs, and (4) classification of periodontal diseases. In summary, the proposed training program will provide Dr. Hujoel with a sound training in the design, analyses, and execution of clinical trials. It will provide him with the opportunity to develop into an independent research investigator, to obtain research experience under the supervision of the Department of Epidemiology and Biostatistics, and to initiate a research program leading to a Ph.D. Dissertation.