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，在2005年，有350,000例乳腺癌或结直肠癌的新病例，与这些癌症有关的近100,000例死亡，这是一个实质性的公共卫生问题，它仍然是国家手术辅助乳房和肠子项目（NSABP）的重点。 40多年来，NSABP在乳腺癌和结直肠癌中成功地进行了大规模的随机临床试验，旨在提高患有这些疾病的人的护理，生活质量和生存标准。 1992年，NSABP开始了预防乳腺癌的计划。在2002 - 2003年，NSABP占乳腺癌患者的64％和78％的结直肠癌患者，他们进入了可用于这些患者的NCI III期试验。这些患者中有超过三分之一由CCOP研究人员招募。自1984年，NSABP成为CCOP研究基础以来，CCOP研究人员已占21,600多名治疗试验患者，并且已招募了33,100名参与者参加了BCPT和Star乳腺癌预防试验。通过这些程序获得的数据的及时性和质量非常出色，并为整体NSABP数据完整性做出了积极贡献，并大大提高了有关癌症治疗和预防的科学信息的基础。ln拟议的项目期限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，癌症控制，癌症控制，科学科学，法律。以这种能力，我们将继续增强对数据收集，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。该研究建议要求资助NSABP生物统计中心的CCOP，MB-CCOP和预防组件的持续运作，该中心提供：1）数据管理支持NSABP试验中数据的数据管理支持； 2）质量保证计划，以确保收集的数据具有最高的完整性； 3）在NSABP研究议程的发展方面的科学合作和对研究进行的后勤支持； 4）对试验和相关研究的设计，监视和分析的统计领导和支持。