Clinical Oncology Program Biostatistical Center

美国癌症协会估计，2005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，这是一个实质性的公共卫生问题 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。1992年，NSABP开始了一项乳腺癌预防计划。在2002-2003年度， NSABP占乳腺癌患者的和结直肠癌患者的78% 进入了为这些患者提供的NCI第三阶段试验。其中超过三分之一的患者 都是由CCOP调查人员登记的。自1984年NSABP成为CCOP研究基地以来， CCOP调查人员已经调查了2.16万多名治疗试验患者和33100多名 参与者已经参加了BCPT和STAR乳腺癌预防试验。及时性和 通过这些计划获得的数据质量一直很高，并为 NSABP数据的整体完整性，并大大增强了关于 癌症的治疗和预防。在拟议的项目期内，资金将用于持续努力 作为支持NSABP CCOP治疗、癌症控制和预防的数据和统计中心 科学议程。在这方面，我们将继续加强利用较新的数据技术 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。这项研究 提案要求提供资金，以使CCOP、MB-CCOP和预防继续发挥作用 NSABP生物统计中心的组成部分，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 收集的数据具有最高的完整性；3)NSABP研究发展中的科学合作 进行研究的议程和后勤支助；以及4)统计领导和支助 试验及相关研究的设计、监测和分析。

The American Cancer Society estimates that in 2005 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. In 1992, the NSABP began a breast cancer prevention program. 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. More than one-third of these patients were enrolled by CCOP investigators. Since 1984, when NSABP became a CCOP Research Base, the CCOP investigators have accounted for more than 21,600 treatment trial patients and more than 33,100 participants have been enrolled in the BCPT and STAR breast cancer prevention trials. The timeliness and quality of data obtained through these programs have been exceptional and have contributed positively to overall NSABP data integrity and substantially enhanced the base of scientific information regarding the treatment and prevention of cancer.ln the proposed project period, funding will be used to sustain our efforts as a data and statistical center in support of the NSABP CCOP treatment, cancer control and prevention scientific agenda. In that capacity, we will continue 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. This research proposal requests funding to enable the continued functioning of the CCOP, MB-CCOP and Prevention components of the NSABP Biostatistical Center which provide: 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.