Biostatistical Center for the NSABP

NSABP 生物统计中心

• 批准号: 7931287
• 负责人: JOSEPH P. COSTANTINO
• 金额: $ 45.51万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7931287
• 关键词: Accounting; Achievement; American Cancer Society; Breast; Cancer Patient; Cessation of life; Clinical Trials; Collaborations; Collection; Colorectal Cancer; Communication; Communities; Correlative Study; Data; Data Collection; Development; Disease; Enrollment; Ensure; Funding; Genes; Goals; Leadership; Malignant Neoplasms; Manuscripts; Methodology; Monitor; National Surgical Adjuvant Breast and Bowel Project; Online Systems; Patients; Persons; Phase III Clinical Trials; Procedures; Protocols documentation; Public Health; Publications; Quality of life; Randomized Clinical Trials; Research; Research Proposals; Role; Site Visit; Training; clinical research site; computerized data processing; data management; design; improved; malignant breast neoplasm; new technology; prognostic; programs; quality assurance; standard of care; statistical center

The American Cancer Society estimates that in 2004 there were more than 350,000 new cases of breast or colorectal cancers and almost 100,000 deaths related to these cancers. This is a substantial public health problem that remains the focus the National Surgical Adjuvant Breast and Bowel Project (NSABP). For more than 40 years, the NSABP has successfully conducted large-scale, randomized clinical trials in breast and colorectal cancer designed to improve the standard of care, quality of life and survival of persons who develop these diseases. This research proposal requests funding to enable the continued functioning of the Biostatistical Center of the NSABP which provides: 1) data management support for the collection and processing of data from NSABP trials; 2) quality assurance programs which ensure that the collected data is of the highest integrity; 3) scientific collaboration in the development of the NSABP research agenda and logistical support for the conduct of the research; and 4) statistical leadership and support for the design, monitoring and analysis of trials and correlative studies. In 2002-2003, the NSABP accounted for 64% of the breast cancer patients and 78% of the colorectal cancer patients who entered the NCI Phase III trials that were available for these patients. Other significant accomplishments made in support of the NSABP scientific agenda during the full course of the prior funding period include: 1) opening of accrual for nine new protocols with 21,000 newly-enrolled patients; 2) data collection and management for 43,000 patients; 3) conducting over 380 site visit audits involving the review of over 5,200 patients charts; 4) implementation of web-based data collection procedures; 5) initiation of an ongoing effort to analyze microarray data to assess prognostic and predictive gene profiles; and 6) the publication of almost 200 manuscripts, 36 of which deal with methodology. In the proposed project period, funding will be used to sustain our efforts as a data and statistical center in support of the NSABP scientific agenda and to enhance the utilization of newer technologies for data collection, data management and the communication and training of clinical site collaborators with the goal of developing more efficient methodologies to design, conduct and analyze clinical trials.

美国癌症协会估计，2004 年有超过 350,000 例新发乳腺癌或癌症病例。 结直肠癌以及近 10 万人与这些癌症相关的死亡。这是一个重大的公共卫生问题 这个问题仍然是国家外科辅助乳腺和肠道项目 (NSABP) 关注的焦点。了解更多 40 多年来，NSABP 已成功开展了乳腺和乳腺疾病的大规模随机临床试验。 结直肠癌旨在提高患者的护理标准、生活质量和生存率 发展这些疾病。该研究提案请求资金支持该研究项目的持续运作 NSABP 生物统计中心提供： 1) 数据收集和管理支持 NSABP 试验数据的处理； 2）质量保证计划，确保收集的数据是 具有最高的诚信度； 3) 制定 NSABP 研究议程方面的科学合作以及 为开展研究提供后勤支持； 4) 统计领导和设计支持， 试验和相关研究的监测和分析。 2002-2003年，NSABP占乳腺癌患者的64%，占结直肠癌患者的78% 进入适用于这些患者的 NCI III 期试验的患者。其他重要的 在先前资助的整个过程中为支持 NSABP 科学议程所取得的成就 期间包括： 1) 九个新方案开始计提，涉及 21,000 名新入组患者； 2）数据 43,000名患者的收集和管理； 3) 进行超过380次涉及审查的现场访问审核 超过 5,200 名患者的图表； 4) 实施基于网络的数据收集程序； 5) 启动 持续努力分析微阵列数据以评估预后和预测基因谱；和 6) 出版了近 200 篇手稿，其中 36 篇涉及方法论。 在拟议的项目期间，资金将用于维持我们作为数据和统计中心的努力 支持 NSABP 科学议程并加强对数据新技术的利用 收集、数据管理以及临床现场合作者的沟通和培训，其目标是 开发更有效的方法来设计、进行和分析临床试验。