Clinical Onology Program Biostatistical Center

临床肿瘤学项目生物统计中心

• 批准号: 7060591
• 负责人: JOSEPH P. COSTANTINO
• 金额: $ 467.21万
• 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 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7060591
• 关键词: behavioral /social science research tag; breast neoplasms; breast surgery; cancer prevention; chemoprevention; clinical research; clinical trials; colorectal neoplasms; combination cancer therapy; combination chemotherapy; community health services; continuing education; cooperative study; data collection methodology /evaluation; female; human subject; human therapy evaluation; information dissemination; neoplasm /cancer chemotherapy; neoplasm /cancer education; neoplasm /cancer surgery; neoplasm /cancer therapy; statistical service /center; statistics /biometry; tamoxifen; therapy compliance

DESCRIPTION: (Applicant?s Description) The National Surgical Adjuvant Breast and Bowel Project (NSABP) is an NCI-funded clinical trials cooperative group for cancer treatment and prevention and control research with a 40-year history of conducting large-scale controlled trials. In 1992, the NSABP extended its research agenda to include cancer prevention trials. The NSABP has been a CCOP Research Base since the inception of the CCOP Program in 1983, and 54 CCOPs currently list the NSABP among their research bases. CCOP participation in NSABP treatment and prevention trials is substantial; approximately 38% of NSABP accrual is attributable to CCOP investigators. This application requests continued funding for the NSABP to continue as a CCOP Research Base for the period June 1, 2001 through May 31, 2006. During the proposed grant period, the NSABP will: 1) continue to design and implement multi-institutional cancer treatment and prevention and control clinical trials; 2) analyze, report, and publish the results of current NSABP studies; 3) implement recruitment mechanisms and procedures to achieve adequate accrual and foster the participation of women and minorities in NSABP clinical trials; 4) maintain data collection, data monitoring, and quality control procedures that are in compliance with federal guidelines; 5) monitor CCOP performance through ongoing quality assurance programs; and 6) continue the integration of CCOP investigators into the overall functioning of the NSABP. In completing these tasks, the specific responsibilities of the Biostatistical Center will include: (I) statistical and logistical design of protocols and ancillary studies; (ii) database design and implementation; (iii) patient/participant eligibility screening and registration; (iv) data management, security and quality assurance; (v) safety, compliance and endpoint monitoring; (vi) preparing reports for treatment and prevention data monitoring committees; (vii) expedited adverse event reporting to regulatory agencies; (viii) statistical analysis of study data; (ix) collaborating in publication of abstracts and manuscripts; (x) managing the on-site audit program; (xi) collaborating in institutional evaluation; and (xii) publishing an annual progress report for the membership.

描述：（申请人的描述）国家手术辅助乳房 和肠项目（NSABP）是NCI资助的临床试验集团 用于癌症治疗，预防和控制研究 进行大规模对照试验的历史。 1992年，NSABP 将其研究议程扩展到包括癌症预防试验。 NSABP 自1983年CCOP计划成立以来，一直是CCOP研究基础 目前有54个CCOP在其研究基础中列出了NSABP。 CCOP 参与NSABP治疗和预防试验是很大的。 大约38％的NSABP应计归因于CCOP研究人员。 该申请要求继续为NSABP继续提供资金 2001年6月1日至2006年5月31日期间的CCOP研究基础。 拟议的赠款期NSABP将： 1）继续设计和实施多机构癌症治疗 预防和控制临床试验； 2）分析，报告和发布当前NSABP研究的结果； 3）实施招聘机制和程序以实现足够的应计 并促进妇女和少数民族参与NSABP临床试验； 4）维护数据收集，数据监视和质量控制程序 符合联邦准则； 5）通过正在进行的质量保证计划监控CCOP的性能；和 6）继续将CCOP调查人员整合到整体功能中 NSABP。 在完成这些任务时，生物统计学的具体责任 中心将包括：（i）协议的统计和后勤设计以及 辅助研究； （ii）数据库设计和实施； （iii） 患者/参与者的资格筛查和注册； （iv）数据 管理，安全和质量保证； （v）安全性，合规性和 端点监视； （vi）准备治疗和预防数据的报告 监测委员会； （vii）加快监管的不良事件报告 机构； （viii）研究数据的统计分析； （ix）合作 摘要和手稿的出版； （x）管理现场审核 程序; （xi）合作进行机构评估；和（xii）出版 会员资格的年度进度报告。