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中文摘要
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描述(申请人提供):西南肿瘤学研究组是一个主要从事多病种、多学科、多机构合作的癌症研究小组。该组织目前由35个成员机构、29个社区临床肿瘤学计划(CCOP)、230个附属机构和26个泌尿系癌症外展计划(UCOP)组成,每年总共有5000名患者参加临床试验。目前,在14个委员会中有96项研究需要进行应计。统计中心对西南肿瘤组癌症研究的设计、实施和分析至关重要。它的主要职能是:(1)参与对拟议方案的审查,特别是在试验设计、样本量和可行性方面;(2)为所有研究的所有患者提供登记,并在适当的情况下提供随机化;(3)开发网络和软件技术,以实现数据的无纸化提交;(4)对研究期间收集的数据进行审查和质量控制;(5)提供数据输入以及计算机处理、存储和检索数据;(6)与小组主席及小组内其他调查人员合作,透过改善表格、更统一和可重现的数据定义,以及更经济的数据流动,以提高临床试验的质素;。(7)协助小组主席管理小组;。(8)与研究协调人分析及公布研究结果;。(9)利用所收集的数据,尝试寻找有关预后因素及后效的新线索;。(10)就癌症临床试验及癌症控制研究的有效设计、进行及分析进行统计研究;。以及(11)教育研究人员、护士肿瘤学家和CRA进行统计分析、研究设计和使用最先进的科学和数据管理策略。
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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