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

基本信息

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
项目类别：
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

项目摘要

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）：在解决RFA HL-05-006中描述的数据协调中心（DCC）的职责时，镰状细胞疾病临床研究网络。 NERI提供以下高度相关的专业知识和经验。（1）拟议的PI，Co-Pi，网络经理和协议经理各自在协调多站点临床试验和流行病学研究的经验超过10年，在镰状细胞疾病，Thalasseala和其他领域。（2）DCC团队包括具有镰状细胞疾病的广泛临床和研究经验的医生，DCC团队与之合作了10多年的医生。（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疾病和其他地区的众多临床试验和流行病学研究。（4）NERI开发了一个专有的，基于甲骨文的数据管理系统-Adept，该系统已在许多多中心试验中成功使用，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的随机化系统，该系统支持许多随机化方案（简单，排列的块，分层的随机化等），并与数据管理系统完全协调。（6）NERI经验丰富，可以建立和运行每个患者的报销系统，包括支持多种报销时间表的支持。（7）NERI和DCC团队在识别和协调中央实验室，终点裁决小组和其他中央阅读面板（例如MRI和MRA）方面经验丰富。（8）DCC团队包括衡量生活质量和成本效益的专业知识，在识别疾病遗传风险因素的统计方面，儿童研究经验以及设计和执行等效性和非秘密试验方面的经验。 NERI团队还建议根据临床试验网络的先前经验合并以下功能。（1）提出了15个临床中心的患者登记处，以评估患者的特征以及每个试验可用的数字的适当性，以在启动复杂的试验方案之前为数据获取和管理提供立即培训工具，并提供持续的患者资源数据库。（2）将在Adept中实现基于Web的数据采集和协议管理系统，该系统将实时向NHLBI的CCS和计划办公室提供自动化的在线报告，这将充分支持以自动报告的网站支付自动报告，以触发付款。 Neri已为DCC组装了一支高度且经验丰富的团队，并提供了成功协调多个并行试验和其他研究所需的数据管理系统和其他资源，这些研究将由Sickle Cell疾病临床研究网络进行。（抽象的结尾）