Blood & Marrow Transplant Clinical Trials Network Data Coordinating Center

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• 批准号: 8413223
• 负责人: Mary Maresca Horowitz
• 金额: $ 451.31万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8413223
• 关键词: Address; Adherence; Blood; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Communication; Data; Data Coordinating Center; Data Quality; Databases; Development; Disease; Effectiveness; Ensure; Evaluation; Funding; Goals; Hematopoietic stem cells; Infection; Laboratories; Malignant - descriptor; Malignant Neoplasms; Manuals; Marrow; Monitor; National Cancer Institute; Non-Malignant; Outcome; Patients; Performance; Phase; Procedures; Quality of life; Relapse; Research; Research Personnel; Resources; Safety; Specimen; Stem cells; System; Therapeutic; Toxic effect; Transplantation; data management; design; effectiveness clinical trial; experience; graft vs host disease; hematopoietic cell transplantation; improved; international center; meetings; member; operation; programs; prospective; protocol development; success

DESCRIPTION (provided by applicant): Hematopoietic stem cell (HCT) transplantation offers curative therapy for a variety of malignant and nonmalignant disorders. It is limited by donor availability, transplant related toxicity, graft versus host disease, relapse of malignancy, infections, and for some patients, reduction in post-transplant quality of life. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) was established in 2001 to develop and execute scientifically meritorious, prospective clinical trials to address these issues. The Network has launched >20 trials with the support of a Data and Coordinating Center (DCC) comprised of a Consortium of the Center for International Blood and Marrow Transplant Research, the National Marrow Donor Program and The EMMES Corporation. The members of this DCC Consortium propose to continue supporting the Network and managing the efficient development, implementation and completion of high-quality Phase l-lll clinical trials for the Network, including concept evaluation and prioritization, protocol development with appropriate statistical designs, timely activation and accrual, monitoring for safety, compliance and data accuracy, and analyzing and disseminating results. The DCC Consortium will coordinate and support all BMT CTN activities maintaining a state-of-the-art database and systems for acquisition and storage of biologic specimens, ensuring data quality, laboratory compliance and adherence to regulatory requirements, managing contractual arrangements and fiscal activities, monitoring and improving center and overall Network performance and supporting all Network committees and activities with meeting planning and other logistical support. The Consortium will also help amplify and leverage Network resources through collaboration with other scientific bodies including National Cancer Institute-funded Cancer Cooperative Groups and the Stem Cell Therapeutic Outcomes Database to maximize successful completion of high quality and high priority clinical trials in HCT. PUBLIC RELEVANCE: The proposed Data and Coordinating Center (DCC) will support all activities of the BMT CTN, using the extensive expertise of the investigators in clinical research and transplantation. We will take advantage of collaborations with other organizations and initiatives to maximize efficiency and trial participation. The goal is to complete high quality clinical trials that focus on the most important barriers to transplant success.

描述（由申请人提供）：造血干细胞（HCT）移植为各种恶性和非恶性疾病提供了根治性治疗。它受到供体可用性、移植相关毒性、移植物抗宿主病、恶性肿瘤复发、感染以及某些患者移植后生活质量下降的限制。血液和骨髓移植临床试验网络（BMT CTN）成立于2001年，旨在开发和执行科学上有价值的前瞻性临床试验来解决这些问题。该网络在数据和协调中心（DCC）的支持下启动了bbb20试验，该中心由国际血液和骨髓移植研究中心、国家骨髓捐献计划和EMMES公司组成。DCC联盟的成员提议继续支持该网络，并管理该网络的高质量i -ll期临床试验的有效开发、实施和完成，包括概念评估和优先级排序、采用适当统计设计的方案开发、及时激活和累积、监测安全性、合规性和数据准确性，以及分析和传播结果。DCC联盟将协调和支持BMT CTN的所有活动，维护最先进的数据库和系统，用于获取和存储生物标本，确保数据质量，实验室合规性和遵守法规要求，管理合同安排和财政活动，监测和改进中心和整体网络性能，并通过会议规划和其他后勤支持支持所有网络委员会和活动。该联盟还将通过与其他科学机构的合作，包括国家癌症研究所资助的癌症合作小组和干细胞治疗结果数据库，帮助扩大和利用网络资源，最大限度地成功完成高质量和高优先级的HCT临床试验。公共相关性：拟议中的数据和协调中心（DCC）将利用临床研究和移植研究人员的广泛专业知识，支持BMT CTN的所有活动。我们将利用与其他组织和倡议的合作，最大限度地提高效率和试验参与。目标是完成高质量的临床试验，重点关注移植成功的最重要障碍。