CONSULTATION ON CLINICAL TRIALS AND OTHER STUDIES

该项目的目的是提供独立咨询， 设计中的统计和流行病学方法， 临床诊断试验的解释和评价， 治疗和预防癌症，以及其他需要这些的研究 一种专业知识。对于某些研究，该科提供了全面的统计数据， 支持，包括制定详细的学习计划; 设计适当的研究表格;监督随机化（对于 试验）;收集、处理和编辑数据; 研究进展期间的中期分析; 进度报告;研究数据的最后分析;以及 编写科学论文。目前的项目包括： 艾滋病预防试验。关于干预试验设计和 正在向NIAID、NIMH和CDC提供有关各个方面的分析 预防艾滋病毒感染和艾滋病。 PSA水平与前列腺癌的发展。联同 癌症预防研究分支，我们正在评估水平的关系 前列腺特异性抗原（PSA）和PSA随时间的变化， 随后的前列腺癌。除了总PSA、游离PSA和 游离/总的比例正在研究中。数据的主要来源 是阿尔法生育酚β胡萝卜素肺癌预防试验， 芬兰. PSA已在所有前列腺癌病例中进行了测量， 匹配的控制。各种数据分析方法正在被 探讨了 关于青少年获得烟草的州法律。与公众合作 健康应用分支，我们正在评估状态的广泛性 关于青年获得烟草和清洁室内空气的法律。我们 利用国家癌症研究所提供的信息，开发和应用一个评级系统 国家癌症立法数据库。 美国农业部饲养研究分析。我们与巨蟹座合作 预防研究分支对美国农业部饲养的一系列分析 对20-40岁妇女的研究。研究正在进行中， 血脂、激素水平和血浆中 类胡萝卜素水平的月经周期的阶段。 息肉预防试验。我们正提供全面的统计资料， 一项多中心饮食干预试验的设计、实施和分析 在2,000名患有结肠腺瘤性息肉的男性和女性中， 或直肠。我们最近贡献了两篇关于设计的论文， 研究和营养干预。我们目前正在分析 关于测量细胞增殖的子研究结果， 约350名参与者。 研究采用和使用初级保健营养指南。的 部门为公共卫生部门提供统计咨询 应用分支的设计、规划和实施， 评估NCI初级保健营养指南的医生实践研究 和内科培训课程（以《指南》为基础）， 家庭医学实践。

The purpose of this project is to provide independent consultation on statistical and epidemiological methodology in the design, interpretation, and evaluation of clinical trials of diagnosis, treatment, and prevention of cancer, and other studies requiring this kind of expertise. For some studies the Section provides full statistical support, including development of detailed study plans; assistance in the design of appropriate study forms; supervision of randomization (for trials); collection, processing, and editing of data; performance of interim analyses during the progress of the study; preparation of progress reports; final analysis of study data; and collaboration in the preparation of scientific papers. Among the current projects are: HIV Prevention Trials. Consultation on intervention trial design and analysis is being provided to the NIAID, NIMH, and CDC on various aspects of the prevention of HIV infection and AIDS. PSA Levels and Development of Prostate Cancer. In collaboration with the Cancer Prevention Studies Branch, we are assessing the relation of levels of prostate-specific antigen (PSA) and change in PSA over time to subsequent prostate cancer. In addition to total PSA, free PSA and the ratio of free/total are being investigated. The primary source of data is the Alpha-Tocopherol Beta-Carotene Lung Cancer Prevention Trial in Finland. PSA has been measured on all cases of prostate cancer and on matched controls. A variety of data analytic approaches are being explored. State Laws on Youth Access to Tobacco. In collaboration with the Public Health Applications Branch, we are evaluating the extensiveness of state laws on youth access to tobacco and on clean indoor air. We are developing and applying a rating system using information from the NCI State Cancer Legislative Database. Analysis of USDA Feeding Studies. We are collaborating with the Cancer Prevention Studies Branch on the analysis of a series of USDA feeding studies of women 20-40 years of age. Research is underway to study the complex relationships between blood lipids, hormone levels, and plasma carotenoid levels by phase of the menstrual cycle. Polyp Prevention Trial. We are providing full statistical support for the design, conduct and analysis of a multicenter dietary intervention trial among 2,000 men and women with a previous adenomatous polyp of the colon or rectum. We have recently contributed to two papers on the design of the study and the nutritional intervention. We are currently analyzing the results of a sub-study on the measurement of cell proliferation in approximately 350 of the participants. Study of the Adoption and Use of the Primary Care Nutrition Guide. The Section has provided statistical consultation to the Public Health Applications Branch on the design, planning, and implementation of a physician practice study evaluating the NCI Primary Care Nutrition Guide and a training course (based on the Guide) among internal medicine and family medicine practices.