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中文摘要
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描述(申请人提供):西南肿瘤研究小组是一个从事肿瘤合作研究的重大多疾病、多学科、多机构小组。该组织现在由35个成员机构,29个社区临床肿瘤项目(CCOPs), 230个附属机构和26个泌尿系统癌症外展项目(UCOPs)组成,每年总共有5000名患者参加临床试验。目前,14个委员会共有96份研究报告可供应计。统计中心对西南肿瘤小组的癌症研究的设计、实施和分析至关重要。其主要职能是:(1)参与方案提案的审查,特别是在实验设计、样本量和可行性方面;(2)对所有研究的所有患者进行登记,并在适当的情况下进行随机化;(三)开发数据无纸化提交的网络和软件技术;(4)对研究期间收集的数据进行审查和质量控制;(五)提供数据录入和计算机处理、存储、检索数据的服务;(6)与小组主席和小组中的其他研究者合作,通过改进表格、更统一和可重复的数据定义以及更经济的数据流来提高临床试验的质量;(7)协助集团主席管理集团;(八)与研究协调员一起分析和发表研究结果;(9)利用收集到的数据,试图找到有关预后因素和后期影响的新线索;(十)对癌症临床试验和癌症控制研究的有效设计、实施和分析进行统计研究;(11)在统计分析、研究设计和使用最先进的科学和数据管理策略方面,对研究人员、肿瘤学护士和CRAs进行教育。
英文摘要
DESCRIPTION (provided by applicant): The Southwest Oncology Group is a major multi-disease, multi-disciplinary, multi-institution group engaged in cooperative cancer research. This organization now consists of 35 Member Institutions, 29 Community Clinical Oncology Programs (CCOPs), 230 Affiliates, and 26 Urologic Cancer Outreach Programs (UCOPs), who together accrue 5,000 patients to clinical trials each year. Currently there are 96 studies open for accrual in 14 committees. The Statistical Center is essential to the design, conduct, and analysis of the cancer research in the Southwest Oncology Group. Its main functions are: (1) to participate in the review of proposed protocols, particularly as regards experimental design, sample size, and feasibility; (2) to provide for registration of all patients on all studies, and for randomization where appropriate; (3) to develop Web and software technology for paperless submission of data; (4) to provide for review and quality control of data collected during studies; (5) to provide for data entry and for computer processing and storage and retrieval of data; (6) to work with the Group chair and other investigators in the Group to improve the quality of clinical trials through improved forms, more uniform and reproducible data definitions, and more economical flow of data; (7) to assist the Group chair in the administration of the Group; (8) to analyze and publish the results of studies in conjunction with the study coordinators; (9) to use the data collected to try to find new leads regarding prognostic factors and late effects; (10) to perform statistical research on the efficient design, conduct, and analysis of cancer clinical trials and cancer control research; and (11) to educate investigators, nurse oncologists and CRAs in statistical analysis, research design and the utilization of the most advanced scientific and data management strategies.
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Addressing the Cancer Burden in South America and the US Hispanic and Native American Populations through Clinical Trials
Biostatistics Core
  • 批准号:
    8395590
  • 项目类别:
  • 资助金额:
    $18.73万
  • 财政年份:
    2012
  • 负责人:
    JOHN J CROWLEY
  • 依托单位:
STATISTICAL METHODS FOR CLINICAL TRIALS
STATISTICAL METHODS FOR CLINICAL TRIALS
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