ECOG-ACRIN Network Group Statistics and Data Management Center

ECOG-ACRIN 网络集团统计和数据管理中心

基本信息

批准号：
10584496
负责人：
CONSTANTINE A. GATSONIS
金额：
$ 772.47万
依托单位：
DANA-FARBER CANCER INST
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-04-29 至 2025-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10584496
关键词：
Achievement Age American College of Radiology American College of Radiology Imaging Network Area Automobile Driving Biological Markers Biometry Cancer Patient Clinical Clinical Research Clinical Trials Collaborations Communities Computational Biology Conduct Clinical Trials Dana-Farber Cancer Institute Data Data Analyses Data Collection Data Coordinating Center Data Science Diagnosis Eastern Cooperative Oncology Group Environment Ethnic Origin Foundations Gender Goals Grant Image Immunotherapy Investigation Laboratories Leadership Medical Research Methodology Mission Monitor Morbidity - disease rate Outcome Patient Outcomes Assessments Patients Phase Population Procedures Process Quality Control Race Research Research Design Research Support Resources Site Statistical Methods System Therapeutic Intervention Universities Vision anticancer research cancer care clinical biomarkers clinical investigation computerized data processing data library data management data submission design high standard image archival system imaging biomarker imaging modality improved multimodality novel marker novel therapeutics operation organizational structure patient safety phase III trial programs quantitative imaging statistics tissue biomarkers treatment adherence

项目摘要

This grant will provide support for the Statistics and Data Management Center (SDMC) of the ECOG- ACRIN Cancer Research Group. The SDMC is organized and operated jointly by the Department of Biostatistics and Computational Biology at the Dana-Farber Cancer Institute (DFCI), the Department of Biostatistics at Brown University, the ECOG-ACRIN Medical Research Foundation (EAMRF), and the American College of Radiology (ACR), under the direction of the Group Statisticians. The primary responsibility for data collection and management belongs to the Data Management Center, consisting of EAMRF and ACR. The primary responsibility for study design, monitoring, and analysis, and for overseeing and coordinating SDMC operations, belongs to the Biostatistics Center, consisting of DFCI and Brown University. The primary contact site for grant administration is DFCI. ECOG-ACRIN is a multi-modality group conducting a wide range of studies, including definitive phase III trials of therapeutic interventions, earlier phase studies developing new therapies, studies focused on diagnosis and of advanced imaging methods, investigation of laboratory and imaging based biomarkers, and studies incorporating patient reported outcomes. The SDMC is responsible for all quantitative aspects of EA's activities. Our overall goals are to conduct clinical trials to the highest standards in statistical methods, data management, and regulatory compliance, while continually improving efficiency of all of our processes and systems to optimize the use of our limited resources. Areas of particular focus in this grant include studies incorporating tissue and imaging biomarkers to direct therapy, studies of immunotherapy, studies of de-intensification of therapy to reduce morbidity, studies investigating novel biomarkers, and studies investigating the relationship of biomarkers and therapy in populations defined by race, ethnicity, gender, and age.

该赠款将为ECOG-的统计和数据管理中心（SDMC）提供支持。 Acrin癌症研究小组。 SDMC由部门共同组织和运营 Dana-Farber癌症研究所（DFCI）的生物统计学和计算生物学布朗大学的生物统计学，ECOG-ACRIN医学研究基金会（EAMRF）和美国放射学院（ACR），在小组统计学家的指导下。主要数据收集和管理的责任属于数据管理中心， EAMRF和ACR。研究设计，监视和分析的主要责任以及监督和协调SDMC操作，属于生物统计学中心，由DFCI组成和布朗大学。授予管理的主要联系地点是DFCI。 ecog-acrin是多模式组进行了广泛的研究，包括确定的III期试验治疗性干预措施，早期研究开发新疗法的研究，重点是诊断以及先进的成像方法，基于实验室和成像的生物标志物的研究，以及结合患者的研究报告了结果。 SDMC负责所有定量方面 EA的活动。我们的总体目标是在统计中进行最高标准的临床试验方法，数据管理和法规合规性，同时不断提高所有效率我们的流程和系统以优化有限资源的使用。特别关注的领域这项赠款包括将组织和成像生物标志物直接治疗的研究，研究免疫疗法，降低疗法降低疗法的研究，研究新的研究生物标志物以及研究生物标志物与疗法的关系的研究根据种族，种族，性别和年龄。