Data Coordinating Center for the Sickle Cell Disease Clinical Research Network

镰状细胞病临床研究网络数据协调中心

• 批准号: 7393723
• 负责人: SONJA M MCKINLAY
• 金额: $ 452.72万
• 依托单位: NEW ENGLAND RESEARCH INSTITUTES, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-10 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7393723
• 关键词: Address; Amino Acids; Anemia; Area; Certification; Cessation of life; Characteristics; Child; Chronic; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Clinical Trials Network; Collection; Combined Modality Therapy; Complex; Consultations; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Reporting; Data Set; Database Management Systems; Databases; Diagnostic; Disease; Effectiveness; End Point; Epidemiologic Studies; Epigenetic Process; Falciparum Malaria; Family; Fee-for-Service Plans; Funding; Genes; Genetic; Genomics; Glutamic Acid; Hemoglobin; Hemoglobinopathies; Individual; Infarction; Injury; International; Ischemia; Laboratories; Living Costs; Magnetic Resonance Imaging; Manuals; Manuscripts; Measures; Monitor; Multi-Institutional Clinical Trial; Mutation; Numbers; Online Systems; Operative Surgical Procedures; Organ; Other Resources; Outcome; Patient Monitoring; Patients; Persons; Pharmaceutical Preparations; Phase III Clinical Trials; Phenotype; Physicians; Preparation; Principal Investigator; Procedures; Proteomics; Protocol Compliance; Protocols documentation; Purpose; Quality of life; Randomized; Reading; Recurrence; Reporting; Research; Research Design; Resources; Review Committee; Running; Sampling; Schedule; Scheme; Scientist; Sickle Cell; Sickle Cell Anemia; Site; Statistical Data Interpretation; Support System; System; Techniques; Teleconferences; Testing; Thalassemia; Therapeutic; Time; Training; Valine; Variant; Work; abstracting; adjudication; base; beta Globin; clinical application; computerized; cost effectiveness; data acquisition; data management; design; editorial; experience; genetic risk factor; improved; patient registry; patient safety; payment; prevent; prognostic; programs; protocol development; quality assurance; repository; sickling; trait

DESCRIPTION (provided by applicant): In addressing the responsibilities of the Data Coordinating Center (DCC) described in the RFA HL-05-006, Sickle Cell Disease Clinical Research Network. NERI offers the following highly relevant expertise and experience. (1) The proposed PI, Co-Pi, Network Manager and Protocol Manager each have more than 10 years of experience in coordinating multi-site clinical trials and epidemiological studies, in sickle cell disease, thalassemia and other areas. (2) The DCC team includes physicians with extensive clinical and research experience in sickle cell disease, physicians with whom the DCC Team has worked for more than 10 years. (3) The DCC includes a strong team of statisticians who have designed, monitored and analyzed numerous clinical trials and epidemiological studies in sickle cell disease and other areas. (4) NERI has developed a proprietary, Oracle-based data management system - ADEPT - that has been used successfully in numerous multi-center trials, including international trials and that supports web-based data entry. (5) NERI has also developed a computerized randomization system that supports many randomization schemes (simple, permuted blocks, stratified randomization, etc.) and which is fully coordinated with the data management system. (6) NERI is experienced at establishing and running per-patient reimbursement systems, including support of multiple schedules for reimbursement. (7) NERI and the DCC team are experienced at identifying and coordinating central laboratories, endpoint adjudication panels and other central reading panels (e.g. MRI and MRA). (8) The DCC team includes expertise in measuring quality of life and cost effectiveness, experience in the statistical aspects of identifying genetic risk factors for disease, experience in research on children and experience in designing and executing equivalence and noninferiority trials. The NERI team also proposes to incorporate the following features, based on prior experience in clinical trials networks. (1) A registry of patients at the 15 Clinical Centers is proposed to assess the characteristics of the patients and the adequacy of the numbers available for each trial, to provide an immediate training vehicle for data acquisition and management before initiating a complex trial protocol, and to provide an ongoing patient resource database. (2) A web-based data acquisition and protocol management system will be implemented in ADEPT that will provide automated on-line reports, in real time, to the CCs and Program Office at NHLBI, and that will fully support per-patient payments to the sites with automated reports for triggering the payments. NERI has assembled a highly and appropriately experienced team for the DCC and offers the data management system and other resources needed to successfully coordinate the multiple parallel trials and other studies that will be undertaken by the Sickle Cell Disease Clinical Research Network. (End of Abstract)

描述（由申请人提供）： 在阐述RFA HL-05-006镰状细胞病临床研究网络中描述的数据协调中心（DCC）的职责时。NERI提供以下高度相关的专业知识和经验。(1)拟议的PI、Co-PI、网络经理和方案经理在协调镰状细胞病、地中海贫血和其他领域的多地点临床试验和流行病学研究方面都有10年以上的经验。(2)DCC团队包括在镰状细胞病方面具有丰富临床和研究经验的医生，DCC团队与他们合作超过10年。(3)DCC包括一个强大的统计学家团队，他们设计，监测和分析了镰状细胞病和其他领域的许多临床试验和流行病学研究。(4)NERI开发了一个专有的基于Oracle的数据管理系统- ADEPT -已成功用于许多多中心试验，包括国际试验，并支持基于Web的数据输入。(5)NERI还开发了一个计算机化随机化系统，支持多种随机化方案（简单、排列区组、分层随机化等）。并与数据管理系统完全协调。(6)NERI在建立和运行每个患者的报销系统方面经验丰富，包括支持多个报销计划。(7)NERI和DCC团队在确定和协调中心实验室、终点裁定小组和其他中心阅读小组（例如MRI和MRA）方面经验丰富。(8)DCC团队包括测量生活质量和成本效益的专业知识，识别疾病遗传风险因素的统计方面的经验，儿童研究经验以及设计和执行等效性和非劣效性试验的经验。 NERI团队还建议根据临床试验网络的先前经验纳入以下功能。(1)建议在15个临床中心进行患者登记，以评估患者特征和每项试验可用人数的充足性，在启动复杂试验方案之前为数据采集和管理提供即时培训工具，并提供持续的患者资源数据库。(2)将在ADEPT中实施基于网络的数据采集和方案管理系统，该系统将向NHLBI的CC和项目办公室提供真实的自动在线报告，并将完全支持向研究中心支付每例患者的费用，自动报告触发付款。 NERI为DCC组建了一支经验丰富的团队，并提供了成功协调镰状细胞病临床研究网络将开展的多项平行试验和其他研究所需的数据管理系统和其他资源。(End摘要）