Randomized Clinical Trials - Whole Genome Studies Coordinating Center

描述(由申请人提供)：华盛顿大学生物统计学系建议建立一个协调中心，用于随机临床试验中治疗反应的一系列全基因组关联研究。协调中心将在生物统计部生物医学统计中心内管理，它将利用作为日内瓦项目协调中心的部门活动所获得的经验。日内瓦是基因-环境倡议范围内的一系列14项全基因组关联研究。新的RTC-WGA协调中心将由Bruce Weir共同指导， 日内瓦协调中心生物统计部和PI主席，帕特里克 生物医学统计中心主任Heagerty说。加入他们的还有生物统计学教员斯科特·爱默生、肯·赖斯、莉安·谢泼德、乔恩·韦克菲尔德、流行病学教员安妮特·菲茨帕特里克和医学系教员布鲁斯·帕蒂。这些教师在进行临床试验和基因研究以及研究环境暴露的影响方面都有丰富的经验。他们将能够向由Lon Cardon、Tom Fleming、Dick Kronmal和Ross Prentice组成的杰出顾问小组寻求建议。 协调中心将管理和协调研究地点临床试验参与者的一套全基因组数据分析的所有活动。该中心将促进跨研究地点、基因分型中心和DBGaP的表型和遗传数据的协调和共享。该中心将通过实施适当的数据管理程序和质量控制活动，确保数据的完整性。协调中心将为复制和后续研究的建模和选择选项提供统计支持，并酌情为测序和功能研究选择目标，以及为随机临床试验固有的问题提供分析支持。 协调中心将作为促进和支持所有NHGRI全基因组关联研究的资源，包括对研究人员进行适当统计方法的培训，并提供用于统计分析的计算机软件。 公共卫生相关性：人们对疾病治疗的反应可能取决于他们的基因构成。如果根据一次简单的血液测试就能预测他们出现不良反应的可能性，那将会有很多好处。确定基因构成和治疗反应之间关系的最好方法是随机临床试验。协调中心将管理这些试验的数据。

DESCRIPTION (provided by applicant): The Department of Biostatistics at the University of Washington proposes to establish a Coordinating Center for a series of genome-wide association studies of treatment response in randomized clinical trials. The Coordinating Center will be administered within the Center for Biomedical Statistics of the Department of Biostatistics and it will take advantage of the experience gained by departmental activities as Coordinating Center for the Geneva project. Geneva is a series of 14 genome-wide association studies within the Gene-Environment Initiative. The new RTC-WGA Coordinating Center will be co-directed by Bruce Weir, Chair of the Department of Biostatistics and PI of the Geneva Coordinating Center, and by Patrick Heagerty, Director of the Center for Biomedical Statistics. They will be joined by Biostatistics faculty Scott Emerson, Ken Rice, Lianne Sheppard, Jon Wakefield, Epidemiology faculty member Annette Fitzpatrick and by Medicine faculty member Bruce Psaty. These faculty have substantial experience in the conduct of both clinical trials and genetic studies, as well as in studying the effects of environmental exposures. They will be able to seek advice from a distinguished advisory panel of Lon Cardon, Tom Fleming, Dick Kronmal and Ross Prentice. The Coordinating Center will provide administration and coordination of all activities for the set of whole-genome analyses of data from participants in clinical trials at study sites. The Center will facilitate harmonization and sharing of phenotypic and genetic data across study sites, the genotyping centers and dbGaP. The Center will assure the integrity of data by implementing appropriate data management procedures and quality control activities. The Coordinating Center will provide statistical support for modeling and selecting options for replication and follow-up studies, and, as appropriate, for selecting targets for sequencing and functional studies as well as analytic support for issues inherent to randomized clinical trials. The Coordinating Center will serve as a resource to facilitate and support all NHGRI whole-genome association studies, including the training of researchers in appropriate statistical methodology and the provision of computer software for statistical analyses. Public Health Relevance: People may respond to treatments for disease in a way that depends on their genetic constitution. There would be many benefits if the possibility that they will have adverse reactions could be predicted on the basis of a simple blood test. The best way to determine the relationship between genetic constitution and response to treatment is with a randomized clinical trial. The coordinating center will manage the data from these trials.