Clinical Oncology Program Biostatistical Center

临床肿瘤学项目生物统计中心

基本信息

批准号：
7658977
负责人：
JOSEPH P. COSTANTINO
金额：
$ 323.26万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
1995
资助国家：
美国
起止时间：
1995-09-01 至 2012-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7658977
关键词：
Accounting American Cancer Society Ancillary Study Breast Breast Cancer Prevention Breast Cancer Prevention Trial Cancer Control Cancer Patient Cessation of life Clinical Clinical Oncology Clinical Trials Clinical Trials Cooperative Group Clinical trial protocol document Collaborations Collection Colorectal Cancer Communication Community Clinical Oncology Program Community Physician Controlled Clinical Trials Correlative Study Data Data Analyses Data Collection Data Quality Development Disease Enrollment Ensure Fostering Funding Goals Incidence Laboratories Leadership Malignant Neoplasms Manuscripts Methodology Minority Monitor National Surgical Adjuvant Breast and Bowel Project Operative Surgical Procedures Participant Patients Performance Persons Phase III Clinical Trials Prevention Prevention program Procedures Protocols documentation Public Health Publishing Quality of life Randomized Clinical Trials Reporting Research Research Personnel Research Proposals Services Training Tumor Biology Woman abstracting base cancer therapy clinical research site computerized data processing data integrity data management design improved malignant breast neoplasm member new technology oncology programs quality assurance standard of care statistical center treatment trial

项目摘要

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.

描述（由申请人提供）：美国癌症协会估计，2005 年有超过 350,000 例新发乳腺癌或结直肠癌病例，近 100,000 例死亡与这些癌症相关。这是一个重大的公共卫生问题，仍然是国家外科委员会关注的焦点。辅助乳腺和肠道项目 (NSABP)。 40 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。 1992 年，NSABP 开始了乳腺癌预防计划。 2002-2003年，NSABP占乳腺癌患者的64%和结直肠癌患者的78%，进入NCI可供这些患者使用的III期试验。 CCOP 研究人员招募了其中超过三分之一的患者。自 1984 年 NSABP 成为 CCOP 研究基地以来，CCOP 研究人员已统计了超过 21,600 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。通过这些项目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，致力于支持 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。该研究提案请求资金支持 NSABP 生物统计中心的 CCOP、MB-CCOP 和预防部分的持续运作，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。