Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center

背痛联盟​​ (BACPAC) 研究计划数据集成、算法开发和运营管理中心

• 批准号: 10396871
• 负责人: Kevin J Anstrom
• 金额: $ 400万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-26 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10396871
• 关键词: Back; Pain; Consortium; BACPAC; Research

ABSTRACT The goal of this U24 application is to establish the Data Integration, Algorithm Development and Operations Management Center (DAC) for NIAMS' Back Pain Consortium (BACPAC) Research Program to ensure that the research objectives are met. The objectives of BACPAC include (i) discovery of lower back pain mechanisms through expert application of clinical and translational medicine methodologies; (ii) identification of new interventions targeted to individual patients through knowledge of established and newly discovered mechanisms; and (iii) evaluation of promising interventions to determine those that warrant further study, potentially leading to regulatory approval. A successful BACPAC research program will be based on cutting edge technologies and reflect the patient-centric focus that is critical to any investigation in this chronic and burdensome disease. Central to this success will be an innovative, forward-looking, and productive DAC that brings cohesion to research performed by the participating Mechanistic Research Centers, Technology Research Sites, and Phase 2 Clinical Trials Centers. DAC Investigators will share their vision and provide scientific leadership and organizational support to the BACPAC Consortium. Our research plan consists of designing and conducting clinical trials with precision interventions in stratified patient populations. Precision medicine interventions that focus on identifying the best treatments for individual patients, instead of the best treatments for the most patients, could improve overall outcomes among this heterogenous patient population. Key elements of the DAC that will enhance collaboration and research progress include experienced leadership, innovative design and analysis methodologies (e.g., sequential adaptive designs, machine learning, neural networks, Q-learning), comprehensive research operations support, a state-of-the-art data management and integration system, and superior administrative support. Our communications infrastructure will provide both public and private websites and a social media presence to effectively disseminate appropriate information to BACPAC investigators, participants, and the public. We will develop a secure, user- friendly advanced data management and integration system that includes web-based access for surveys, data entry, research management (including comprehensive reporting, biosample tracking and performance-based reimbursement tools), integration with external applications, and quality control. Our research operations and administration teams will provide a solid foundation to the BACPAC Research Program by facilitating meetings, collaborative document preparation, tracking of regulatory compliance, and support for abstract and publication preparation across the BACPAC Consortium. Together, this integrated structure will set the stage for technology assessments, solicitation of patient input and utilities, and the evaluation of high-impact interventions through the innovative design and sound execution of clinical trials, leading to effective personalized treatment approaches for patients with chronic lower back pain.

抽象的 该 U24 应用程序的目标是建立数据集成、算法开发和运营 NIAMS 背痛联盟 (BACPAC) 研究计划管理中心 (DAC)，以确保 研究目标得到满足。 BACPAC 的目标包括 (i) 发现腰痛 通过临床和转化医学方法的专家应用来建立机制； (二) 识别 通过了解已建立的和新发现的知识，针对个体患者进行新的干预措施 机制； (iii) 评估有希望的干预措施，以确定那些值得进一步研究的干预措施， 可能会获得监管部门的批准。成功的 BACPAC 研究计划将基于削减 尖端技术并反映以患者为中心的重点，这对于这种慢性病和慢性病的任何调查都至关重要 负担重的疾病。这一成功的核心是一个创新、前瞻性和高效的 DAC， 为参与的机械研究中心、技术中心进行的研究带来凝聚力 研究中心和二期临床试验中心。 DAC 调查员将分享他们的愿景并提供 对 BACPAC 联盟的科学领导和组织支持。我们的研究计划包括 在分层患者群体中设计和进行精确干预的临床试验。精确 医学干预措施侧重于为个体患者确定最佳治疗方法，而不是最佳治疗方法 对大多数患者进行治疗可以改善这一异质患者群体的总体结果。 DAC 将加强合作和研究进展的关键要素包括经验丰富的 领导力、创新设计和分析方法（例如顺序自适应设计、机器 学习、神经网络、Q-learning）、全面的研究运营支持、最先进的数据 管理和集成系统以及高级行政支持。我们的通讯基础设施 将提供公共和私人网站以及社交媒体，以有效传播 向 BACPAC 调查人员、参与者和公众提供适当的信息。我们将开发一个安全的、用户友好的 友好的高级数据管理和集成系统，包括基于网络的调查、数据访问 进入、研究管理（包括综合报告、生物样本跟踪和基于绩效的 报销工具）、与外部应用程序的集成以及质量控制。我们的研究业务和 管理团队将通过促进会议、 协作文档准备、监管合规性跟踪以及摘要和出版支持 BACPAC 联盟的准备工作。总之，这个一体化的结构将为 技术评估、征求患者意见和实用程序以及高影响力的评估 通过临床试验的创新设计和良好执行进行干预，从而产生有效的效果 慢性腰痛患者的个性化治疗方法。