ECOG Statistical Office

经济组统计办公室

基本信息

批准号：
7276141
负责人：
ROBERT J GRAY
金额：
$ 236.71万
依托单位：
DANA-FARBER CANCER INST
依托单位国家：
美国
项目类别：
财政年份：
1978
资助国家：
美国
起止时间：
1978-03-01 至 2010-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7276141
关键词：
AML/MDS Access to Information Accounting Activation Date Acute Acute Promyelocytic Leukemia Address Adjuvant Adjuvant Study Administrator Adopted Adoption Adult Adverse Drug Experience Reporting System Adverse effects Adverse event Affect African American Agreement Algorithms All Sites Amendment American College of Radiology American Society of Clinical Oncology American Society of Hematology Antigens Application procedure Area Authorization documentation Award Back Basic Science Bayesian Analysis Bibliography Bioinformatics Biological Markers Biometry Bite Blinded Blood Books Brain Brain Neoplasms Breast Budgets Business Rules Businesses CD-ROM Cancer Center Cancer Control Cancer Patient Cancer Survivor Cancer Therapy Evaluation Program Cancer Trials Support Unit Cancer and Leukemia Group B Carboxyamidotriazole Case Report Form Case Study Categories Caucasians Caucasoid Race Charge Chemistry Chest Cisplatin Class Classification Clinic Clinical Clinical Data Clinical Data Update System Clinical Investigator Clinical Protocols Clinical Research Clinical Research Associate Clinical Trials Clinical Trials Cooperative Group Clinical Trials Data Monitoring Committees Clinical Trials Design Clinics and Hospitals Closure Code Coin Collection Colon Carcinoma Commit Committee Members Common Data Element Common Terminology Criteria for Adverse Events Communication Communities Community Clinical Oncology Program Complex Complication Computer Security Computer Systems Computer Systems Development Computer software Computers Concept Review Conduct Clinical Trials Confidence Intervals Confidentiality Conflict of Interest Congresses Consent Consent Forms Contractor Contracts Controlled Clinical Trials Controlled Study Copyright Correlative Study Count Critiques Cross-Over Studies Custom Cytotoxic agent Daily Dana-Farber Cancer Institute Data Data Analyses Data Base Management Data Collection Data Coordinating Center Data Element Data Files Data Quality Data Reporting Data Set Data Storage and Retrieval Database Management Systems Databases Date of birth Date/Time Decision Making Derivation procedure Development Development Plans Devices Diabetes Mellitus Diagnostic Imaging Dictionary Digit structure Discipline Disease Disorder by Site Doctor of Philosophy Documentation Dose Dose-Limiting Drug Formulations Eastern Cooperative Oncology Group Education Educational Status Educational workshop Effectiveness Elderly Electronic Mail Electronics Elements Eligibility Determination Employee End Point Enrollment Ensure Environment Equilibrium Equipment and supply inventories Ethnic Origin Ethnic group Evaluation Evaluation Studies Event Exercise stress test Expectancy Experimental Designs Extensible Markup Language Factor Analysis Faculty Failure FarGo Feasibility Studies Feedback Floor Focus Groups Follow-Up Studies Foundations Freezing Funding Future GDF15 gene Gender Generations Genus - Lotus Goals Grant Gray unit of radiation dose Group Meetings Group Processes Group Purchasing Guidelines Hand Head Head and Neck Cancer Head and neck structure Health Insurance Portability and Accountability Act Health behavior Healthcare Hematology Hodgkin Disease Hormonal Hospital Records Hospitals Hour Housing Human Human Resources Human Subject Research Image Impact evaluation Incidence Individual Industry Information Services Information Systems Information Technology Informed Consent Institutes Institution Intention Intercept Interferon-alpha International Internet Intervention Investigation Journals Label Laboratories Laboratory Scientists Laboratory Study Language Latex Lead Leadership Learning Left Letters Librarians Libraries Licensing Life Lilium Link Literature Local Area Networks Location Logic Lymphoma Mails Maintenance Malignant Neoplasms Malignant neoplasm of gastrointestinal tract Malignant neoplasm of kidney Malignant neoplasm of lung Management Information Systems Manuals Manuscripts Maps Marketing Massachusetts Measurement Measures Mediation Medical Records Melissa Mentors Metastatic Melanoma Methodology Methods Minority Mission Modality Modeling Modification Monitor Motivation Multi-Institutional Clinical Trial Multiple Myeloma Names National Cancer Institute Natural regeneration Nature New Agents Nodal Non-Small-Cell Lung Carcinoma Nonprofit Organizations Normal Range North Central Cancer Treatment Group Notification Numbers Nurses Object Attachment Office of Administrative Management Oncologic Nursing Oncology Nurse One-Step dentin bonding system Online Systems Operative Surgical Procedures Outcome Output PLAB Protein Paper Parents Participant Pathologist Pathology Pathology Report Patient Noncompliance Patient Selection Patients Pattern Peer Review Performance Pharmaceutical Preparations Pharmacologic Substance Phase Phase I Clinical Trials Phase II Clinical Trials Phase III Clinical Trials Physicians Pilot Projects Planet Mars Plant Roots Play Pliability Plug-in Policies Policy Developments Population Positioning Attribute Pre-study Preparation Prevention Price Principal Investigator Printing Privacy Probability Procedures Process Production Prognostic Factor Progress Reports Progression-Free Survivals Prohibit Protocol Compliance Protocols documentation Public Health Schools Publications Published Comment Publishing Purpose Quality Control Quality of life Race Radiation Oncology Radiation Therapy Oncology Group Radiation therapy Randomized Randomized Controlled Clinical Trials Range Rate Reaction Reading Recommendation Recording of previous events Records Recurrence Relative (related person)Reliance Renal Cell Carcinoma Renal carcinoma Reporting Request for Applications Research Research Design Research Ethics Committees Research Infrastructure Research Personnel Reservations Resolution Resources Retrieval Risk Risk Factors Role Route Running Ruta SAS Safety Sample Size Sampling Scanning Schedule Science Scientist Score Screening procedure Second Primary Cancers Secure Security Series Serious Adverse Event Services Side Significance Level Site Site Visit Social Security Number Software Validation Solid Solid Neoplasm Solutions Source Southwest Oncology Group Specialist Specific qualifier value Specimen Speed Spottings Stable Disease Staff Development Staging Standard Preparations Standardization Standards of Weights and Measures Statistical Computing Statistical Methods Statistical Study Stratification Stratification Factors Structure Study Section Subgroup Supervision Support System Survival Rate Suspension substance Suspensions System Target Populations Technical Expertise Technology Telefacsimile Telephone Terminology Testing Text Therapeutic Therapeutic Clinical Trial Therapeutic Studies Thesauri Thinking Thoracic Oncology Tigers Time Time Study Tissue Banks Tissue Sample Tissues Title To specify Toxic effect Toxicity due to chemotherapy Training Training Activity Training Programs Training and Education Translating Transplantation Travel Treatment Protocols Treatment Step Tretinoin Uncontrolled Study United States Food and Drug Administration Universities Update Upper arm Urogenital Cancer Valid Value Validation Vendor Virus Visit Voting Waiting Lists Walking Week Weight Woman Work Workload Writing abstracting adjudicate administrative database anticancer research base cancer therapy chemotherapy clinical application commercial application computer generated computerized computerized data processing concept cost cost effective dalton data integrity data management database design day demographics design development policy digital disorder prevention efficacy evaluation encryption expectation experience falls file format firewall follow-up frontier hazard human subject improved indexing innovation instrument interest lecturer lectures leukemia leukemia/lymphoma malignant breast neoplasm medical schools melanoma member microwave electromagnetic radiation migration new technology optical character recognition outcome forecast patient safety payment pressure prevent probation prognostic programs protocol development quality assurance racial and ethnic response sarcoma simulation size skills software development software systems statistical center statistics success symposium symptom management syntax technical report theories time use tool tool development trafficking transmission process treatment duration treatment effect treatment trial tumor upper GI series validation studies web based interface web interface

项目摘要

DESCRIPTION (provided by applicant): This application requests six years of support for the ECOG Statistical Center. It is a combined narrative for the separate awards for the Statistical Office and the Data Management Office. The objectives of the Statistical Center are to provide leadership and support for ECOG in the areas of design and analysis of clinical and laboratory studies, database analyses and investigator initiated grants, study monitoring, data management procedures and systems, processing and quality control of data, education and training activities, administrative management, and information systems. During this period, ECOG statisticians have continued their strong tradition of leadership in the design and analysis of clinical trials. The statisticians have been coauthors on 143 published ECOG papers, have performed numerous database analyses, and are now providing support for approximately 10 investigator-initiated grants per year. Some of the major accomplishments in data management during the last 5 years include changes in data management procedures to improve efficiency and standardization, including increasing use of computerized processing, improved documentation of procedures, and changes in the routing of data on intergroup studies, active participation in the NCI's Common Data Elements project to standardize data terminology, development of standardized procedures and computer applications for processing data for the new solid tumor response criteria, establishing and implementing guidelines for follow-up durations on ECOG studies and terminating follow-up on many old studies, and development of policies to facilitate compliance with the HIPAA privacy rule by ECOG's member institutions. The efforts to develop better computer applications for data management within the old Ingres database environment eventually led to the realization that it was not an adequate platform on which to build for the future. After investigation of various options, ECOG decided to convert its data management operation to Oracle Clinical. Significant progress on the conversion has been made, with the first study going into production in Oracle in early May. With over 30 years of data from hundreds of studies, and hundreds of applications and reports that access the ECOG database and administrative tables stored in Ingres, the process of data migration and application conversion will continue for several years. This will be the dominant development activity in both data management and in the Information Systems (IS) group for the early part of the next grant period. The IS group has developed a number of important new applications during the last grant period, including enhancements to the ECOG web site, new tools for processing expedited adverse event systems, new follow-up expectancy reporting tools, database procedures for automatic grading of hematology/chemistry related toxicities, tools for processing response data, enhanced support for fiscal management and reimbursement, and new regulatory support systems. The SAS programmers have developed a suite of macros to support data retrieval, reporting and analysis and for performing a variety of data quality control checks. Future Information Systems plans include implementation of improved document management systems, secure communications systems, and document imaging systems for on-line availability of forms and other documents.

描述（由申请人提供）：本申请要求 ECOG 统计中心获得六年的支持。这是统计办公室和数据管理办公室单独奖项的综合叙述。统计中心的目标是在临床和实验室研究的设计和分析、数据库分析和研究者发起的资助、研究监测、数据管理程序和系统、数据处理和质量控制等领域为 ECOG 提供领导和支持，教育和培训活动、行政管理和信息系统。在此期间，ECOG 统计学家延续了他们在临床试验设计和分析方面的强大领导传统。统计学家是 143 篇已发表的 ECOG 论文的合著者，进行了大量数据库分析，现在每年为大约 10 项研究者发起的资助提供支持。过去 5 年数据管理方面的一些主要成就包括改变数据管理程序以提高效率和标准化，包括增加计算机化处理的使用、改进程序记录、改变组间研究数据路由、积极参与在 NCI 的通用数据元素项目中，标准化数据术语、开发标准化程序和计算机应用程序来处理新实体瘤反应标准的数据、建立和实施 ECOG 研究随访时间指南以及终止许多旧研究的随访研究，制定政策以促进 ECOG 成员机构遵守 HIPAA 隐私规则。在旧的 Ingres 数据库环境中开发更好的数据管理计算机应用程序的努力最终导致人们认识到它不是一个适合未来构建的平台。在对各种选项进行调查后，ECOG 决定将其数据管理操作转换为 Oracle Clinical。转换方面已经取得了重大进展，第一项研究已于 5 月初在 Oracle 投入生产。凭借来自数百项研究的 30 多年数据以及访问 Ingres 中存储的 ECOG 数据库和管理表的数百个应用程序和报告，数据迁移和应用程序转换过程将持续数年。这将是下一个资助期初期数据管理和信息系统（IS）组的主要开发活动。 IS 小组在上一次拨款期间开发了许多重要的新应用程序，包括对 ECOG 网站的增强、用于处理快速不良事件系统的新工具、新的后续预期报告工具、用于血液学/自动分级的数据库程序化学相关毒性、处理响应数据的工具、加强对财政管理和报销的支持以及新的监管支持系统。 SAS 程序员开发了一套宏来支持数据检索、报告和分析以及执行各种数据质量控制检查。未来的信息系统计划包括实施改进的文档管理系统、安全通信系统和文档成像系统，以便在线提供表格和其他文档。