CONSULTATION ON CLINICAL TRIALS AND OTHER STUDIES

该项目的目的是就以下问题提供独立咨询 设计中的统计和流行病学方法， 对诊断的临床试验进行解释和评估， 癌症的治疗和预防，以及其他需要这样做的研究 一种专业知识。对于一些研究，该科提供了完整的统计数据。 支持，包括制定详细的研究计划；协助 设计适当的研究表格；监督随机化(用于 试验)；数据的收集、处理和编辑；执行 研究进展过程中的中期分析；准备 进度报告；研究数据的最终分析；以及在 准备科学论文。目前的项目包括： 艾滋病毒预防试验。关于干预试验设计和实施的咨询 正在向NIAID、NIMH和CDC提供各方面的分析 预防艾滋病毒感染和艾滋病。 PSA水平与前列腺癌发生发展的关系与 癌症预防研究科，我们正在评估 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、免费PSA和 自由/总量的比率正在调查中。数据的主要来源 α-生育酚-β-胡萝卜素预防肺癌试验 芬兰。前列腺癌和其他疾病的所有病例都进行了PSA检测。 配对的对照组。各种各样的数据分析方法正在出现 探索过了。 关于青少年接触烟草的州法律。与公众合作 卫生应用处，我们正在评估国家的广泛性 关于青少年吸烟和清洁室内空气的法律。我们是 利用NCI的信息开发和应用评级系统 州癌症立法数据库。 美国农业部喂养研究分析。我们正在与癌症协会合作 预防研究分部对美国农业部一系列喂养的分析 研究对象为20-40岁的女性。目前正在进行研究，以研究 血脂、激素水平和血浆之间的复杂关系 月经周期各阶段的类胡萝卜素水平。 息肉预防试验。我们正在提供全面的统计支持 一项多中心饮食干预试验的设计、实施和分析 在2000名既往患有结肠腺瘤性息肉的男性和女性中 或者直肠。我们最近发表了两篇关于设计的论文 研究及营养干预。我们目前正在分析 一项关于测量细胞增殖的子研究的结果 大约350名参与者。 《初级保健营养指南》的采纳和使用情况研究这个 为公共卫生部门提供了统计咨询 应用程序科负责设计、规划和实施 评估NCI初级保健营养指南的医生实践研究 以及内科和内科的培训课程(根据指南) 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.