Clinical Oncology Program Biostatistical Center

描述（由申请人提供）：美国癌症协会估计，2005年有超过35万例乳腺癌或结直肠癌新病例，近10万例死亡与这些癌症有关，这是一个重大的公共卫生问题，仍然是国家乳房和肠道手术辅助项目（NSABP）的重点。40多年来，NSABP成功地在乳腺癌和结直肠癌中进行了大规模的随机临床试验，旨在提高这些疾病患者的护理标准、生活质量和生存率。1992年，NSABP开始了一项乳腺癌预防计划。在2002-2003年，进入NCI III期试验的乳腺癌患者中，NSABP占64%，结直肠癌患者中占78%。这些患者中超过三分之一是由CCOP研究人员登记的。自1984年NSABP成为CCOP研究基地以来，已有超过21,600名治疗试验患者和超过33100名参与者参加了BCPT和STAR乳腺癌预防试验。通过这些项目获得的数据的及时性和质量是卓越的，对NSABP总体数据的完整性做出了积极的贡献，并大大增强了有关癌症治疗和预防的科学信息基础。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 CCOP治疗，癌症控制和预防的科学议程。在这种情况下，我们将继续加强对数据收集、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，目的是开发更有效的方法来设计、进行和分析临床试验。本研究计划申请资金支持NSABP生物统计中心的CCOP、MB-CCOP和Prevention组件的持续运作，这些组件提供：1)为NSABP试验数据的收集和处理提供数据管理支持；2)质量保证程序，确保所收集的数据具有最高的完整性；3)制定NSABP研究议程的科学合作和开展研究的后勤支持；4)对试验和相关研究的设计、监测和分析提供统计领导和支持。

DESCRIPTION (provided by applicant): 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.