Biostatistical Center for the NSABP

描述（由申请人提供）：美国癌症协会估计，2004年有超过35万例乳腺癌或结直肠癌新发病例，近10万例与这些癌症有关的死亡。这是一个重大的公共卫生问题，仍然是国家外科辅助乳腺和肠道项目（NSABP）的重点。40多年来，NSABP成功地进行了乳腺癌和结直肠癌的大规模随机临床试验，旨在改善这些疾病患者的护理标准、生活质量和生存率。该研究提案要求提供资金，以使国家生物安全局生物统计中心能够继续运作，该中心提供：1）数据管理支持，以收集和处理国家生物安全局试验的数据; 2）质量保证方案，确保收集的数据具有最高的完整性;（3）在制定《国家生物多样性战略框架》研究议程方面开展科学合作，并为开展研究提供后勤支持;和4）对试验和相关研究的设计、监测和分析的统计领导和支持。 2002-2003年，NSABP占进入NCI III期试验的乳腺癌患者的64%和结肠直肠癌患者的78%。在上一个供资期的整个过程中，为支持国家生物安全与生物多样性战略计划的科学议程而取得的其他重大成就包括：1）为9项新方案启动了21，000名新入组患者的应计项目; 2）为43，000名患者收集和管理数据; 3）进行了380多次现场访问审计，涉及审查5，200多份患者病历; 4）实施基于网络的数据收集程序; 5）开始持续努力分析微阵列数据，以评估预后和预测基因谱; 6）出版近200篇手稿，其中36篇涉及方法学。 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，以支持NSABP的科学议程，并加强利用新技术进行数据收集，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，进行和分析临床试验。

DESCRIPTION (provided by applicant): 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 percent of the breast cancer patients and 78 percent 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.