Biostatistical Center for the NSABP

美国癌症协会估计，2004年有超过35万例乳腺癌或乳腺癌的新病例 结直肠癌和与这些癌症有关的近100,000人死亡。这是一个相当大的公共卫生问题 这个问题仍然是国家外科辅助乳肠项目(NSABP)的焦点。了解更多 40多年来，NSABP成功地在乳房和乳房进行了大规模、随机的临床试验 旨在提高护理水平、生活质量和生存的结直肠癌患者 发展出这些疾病。这项研究提案要求提供资金，以使 NSABP生物统计中心提供：1)数据管理支持收集和 处理NSABP试验的数据；2)质量保证计划，确保收集的数据是 最高诚信；3)在制定NSABP研究议程方面的科学合作和 对进行研究的后勤支持；以及4)对设计的统计领导和支持， 对试验和相关研究进行监测和分析。 2002年至2003年，非小细胞肺癌患者占乳腺癌患者的%，占结直肠癌患者的78% 进入NCI第三阶段试验的患者可用于这些患者。其他重要的 在前一次资助的整个过程中为支持NSABP科学议程而取得的成就 期间包括：1)启动9个新方案的应计项目，新增21,000名患者；2)数据 收集和管理43,000名患者；3)进行380多次现场访问审计，涉及审查 超过5,200名患者的病历；4)实施基于网络的数据收集程序；5)启动 分析微阵列数据以评估预后和预测性基因图谱的持续努力；以及6) 出版了近200份手稿，其中36份涉及方法论。 在拟议的项目期内，资金将用于维持我们作为数据和统计中心的努力。 支持NSABP的科学议程，并加强数据新技术的利用 收集、数据管理以及临床现场合作者的沟通和培训，目标是 开发更有效的方法来设计、进行和分析临床试验。

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.