Clinical Oncology Program Biostatistical Center

描述（由申请人提供）：美国癌症协会估计，每年有超过35万例新的乳腺癌或结直肠癌病例，近10万人死于这些癌症。这是一个重大的公共卫生问题，仍然是国家外科辅助乳房和肠项目（NSABP）的重点。50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。自1984年NSABP成为CCOP研究基地以来，CCOP研究人员约有30,000名治疗试验患者，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。在这方面，我们将继续加强对数据收集、数据管理和临床现场合作者的沟通和培训的新技术的利用，以开发更有效的方法来设计、实施和分析临床试验。本研究提案请求资助，以使nabp生物统计中心的CCOP、MB-CCOP和预防部分继续发挥作用，这些部分提供：1)数据管理支持NSABP试验数据的收集和处理；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 annually there are 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 50 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. Since 1984, when NSABP became a CCOP Research Base, the CCOP investigators have accounted for approximately 30,000 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 have substantially enhanced the base of scientific information regarding the treatment and prevention of cancer. In 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. RELEVANCE (See instructions): Breast and Colorectal cancer is a substantial public health problem that is the focus of the National Surgical Adjuvant Breast and Bowel Project (NSABP). The focus of the NSABP is the conduct of large-scale, clinical trials designed to improve the standard of care, quality of life and survival of persons who develop these diseases as well as the conduct of breast and colorectal cancer prevention studies. Our current and planned studies are designed to improve the prevention and treatment of these diseases.