Clinical Oncology Program Biostatistical Center

临床肿瘤学项目生物统计中心

• 批准号: 8306364
• 负责人: JOSEPH P. COSTANTINO
• 金额: $ 388.85万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-01 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8306364
• 关键词: Accounting; American Cancer Society; Ancillary Study; Breast Cancer Prevention Trial; Cancer Control; Cessation of life; Clinical Oncology; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Design; Collaborations; Collection; Colorectal Cancer; Communication; Community Clinical Oncology Program; Community Physician; Controlled Clinical Trials; Correlative Study; Data; Data Collection; Data Quality; Development; Disease; Enrollment; Ensure; Fostering; Funding; Funding Opportunities; Goals; Incidence; Institution; Instruction; Leadership; Malignant Neoplasms; Methodology; Minority; Monitor; National Surgical Adjuvant Breast and Bowel Project; Participant; Patients; Performance; Persons; Prevention; Procedures; Public Health; Publishing; Quality of life; Randomized Clinical Trials; Reporting; Research; Research Design; Research Personnel; Research Proposals; Services; Training; Tumor Biology; Woman; base; cancer prevention; cancer therapy; clinical research site; colorectal cancer prevention; computerized data processing; data integrity; data management; design; improved; malignant breast neoplasm; member; new technology; oncology program; operation; programs; quality assurance; standard of care; statistical center; treatment trial

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.

描述（由申请人提供）：美国癌症协会估计，每年有超过 350,000 例乳腺癌或结直肠癌新病例，以及近 100,000 例与这些癌症相关的死亡。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) 关注的焦点。 50 多年来，NSABP 成功开展了针对乳腺癌和结直肠癌的大规模随机临床试验，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 研究人员已统计了约 30,000 名治疗试验患者，超过 33,100 名参与者参加了 BCPT 和 STAR 乳腺癌预防试验。通过这些计划获得的数据的及时性和质量非常出色，对整体 NSABP 数据完整性做出了积极贡献，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、癌症控制和预防科学议程。以此身份，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，以开发更有效的方法来设计、进行和分析临床试验，本研究提案要求为 NSABP 生物统计中心的 CCOP、MB-CCOP 和预防部分的持续运作提供资金，这些部分提供： 1) 为收集和处理 NSABP 试验数据提供数据管理支持； 2) 确保所收集数据具有最高完整性的质量保证计划； 3) 制定 NSABP 研究议程的科学合作以及为开展研究提供后勤支持； 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。 相关性（参见说明）：乳腺癌和结直肠癌是一个重大的公共卫生问题，也是国家乳腺癌和肠道辅助手术项目 (NSABP) 的重点。 NSABP 的重点是开展旨在提高这些疾病患者的护理标准、生活质量和生存率的大规模临床试验，以及开展乳腺癌和结直肠癌预防研究。我们当前和计划中的研究旨在改善这些疾病的预防和治疗。