Biostatistical Center for the NSABP

美国癌症协会估计，2004年有超过350，000例新的乳腺癌或乳腺癌病例。 结直肠癌和近100，000例与这些癌症有关的死亡。这是一个实质性的公共卫生 这个问题仍然是国家外科辅助乳腺和肠道项目（NSABP）的焦点。有关详细 40多年来，NSABP成功地进行了大规模的随机临床试验， 结肠直肠癌，旨在提高护理标准，生活质量和生存的人， 发展这些疾病。这项研究提案要求提供资金，以使该中心能够继续运作。 NSABP的生物统计中心，提供：1）数据管理支持， NSABP试验数据的处理; 2）质量保证计划，确保收集的数据 3）在制定国家生物多样性战略计划研究议程方面开展科学合作， 为开展研究提供后勤支持;以及4）统计领导和对设计的支持， 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NCI III期试验的患者。其他重大 在先前供资的整个过程中，在支持国家生物多样性战略计划科学议程方面取得的成就 期间包括：1）开放9项新方案的入组，21，000例新入组患者; 2）数据 收集和管理43，000名患者; 3）进行超过380次涉及审查的现场访问审计 5 200多份病历; 4）实施基于网络的数据收集程序; 5）启动 正在进行的分析微阵列数据以评估预后和预测基因谱的努力;以及6） 出版了近200份手稿，其中36份涉及方法学。 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《国家生物多样性战略框架》的科学议程，并加强利用新的数据技术 收集、数据管理以及临床研究中心合作者的沟通和培训，目标是 开发更有效的方法来设计、实施和分析临床试验。

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.