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350,000例新的乳房或 结直肠癌和与这些癌症有关的近100,000例死亡。这是一个实质性的公共卫生 问题仍然是全国手术辅助乳房和肠项目（NSABP）的重点。更多 超过40年，NSABP在乳房和 结直肠癌旨在提高护理标准，生活质量和人的生存 发展这些疾病。该研究建议要求资助以实现 NSABP的生物统计中心提供：1）集合的数据管理支持和 从NSABP试验处理数据； 2）质量保证计划，以确保收集的数据为 最高的完整性； 3）NSABP研究议程和发展方面的科学合作 后勤支持研究的行为； 4）统计领导和对设计的支持， 监测和分析试验和相关研究。 在2002 - 2003年，NSABP占乳腺癌患者的64％和78％的大肠癌 进入NCI III期试验的患者可用于这些患者。其他重要 在以前的资金的全部课程中，为支持NSABP科学议程而取得的成就 周期包括：1）为九种新方案开放，有21,000例新摄制的患者； 2）数据 43,000名患者的收集和管理； 3）进行380多个现场访问审核，涉及审查 超过5200名患者图表； 4）实施基于Web的数据收集过程； 5）启动 不断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个手稿，其中36个涉及方法论。 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，并增强对数据的新技术的利用 收集，数据管理以及临床现场合作者的沟通和培训，目的是 开发更有效的方法来设计，进行和分析临床试验。