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350,000例新的乳腺癌或结直肠癌病例，近100,000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肠项目(NSABP)的重点。40多年来，NSABP成功地对乳腺癌和结直肠癌进行了大规模、随机的临床试验，旨在提高这些疾病患者的护理水平、生活质量和存活率。这项研究提案要求提供资金，以使NSABP生物统计中心继续发挥作用，该中心提供：1)为NSABP试验数据的收集和处理提供数据管理支持；2)质量保证计划，确保收集的数据具有最高的完整性；3)在NSABP研究议程的制定方面进行科学合作，并为研究的进行提供后勤支持；以及4)为试验和相关研究的设计、监测和分析提供统计领导和支持。 2002年至2003年，进入NCI第三阶段试验的乳腺癌患者和结直肠癌患者中有78%的患者参加了NSABP。在前一个资助期内，在支持NSABP科学议程方面取得的其他重大成就包括：1)启动了9个新方案的应计项目，新登记了21,000名患者；2)收集和管理了43,000名患者；3)进行了380多次现场访问审计，审查了5,200多名患者的病历；4)实施了网上数据收集程序；5)开始持续分析微阵列数据，以评估预后和预测性基因图谱；以及6)出版了近200篇手稿，其中36篇涉及方法学。 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，以支持NSABP的科学议程，并加强对数据收集、数据管理以及临床现场合作者的沟通和培训的新技术的利用，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.