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

摘要 该U24应用程序的目标是建立数据集成、算法开发和操作 NIAMS背痛联盟(BACPAC)研究计划的管理中心(DAC)以确保 达到了研究目标。BACPAC的目标包括(I)发现下腰痛 通过临床和转化医学方法的专家应用建立机制；(2)确定 通过已有和新发现的知识针对个别患者的新干预措施 (3)对有希望的干预措施进行评估，以确定哪些干预措施值得进一步研究， 这可能会导致监管部门的批准。一个成功的BACPAC研究项目将以切割为基础 边缘技术，并反映了以患者为中心的重点，这对任何长期和 繁重的疾病。这一成功的核心将是一个创新、前瞻性和富有成效的DAC 为参与的力学研究中心进行的研究带来凝聚力，技术 研究网站和第二阶段临床试验中心。DAC调查人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 在分层患者人群中设计和实施精确干预的临床试验。精密度 药物干预，侧重于确定针对个别患者的最佳治疗方案，而不是最佳方案 对大多数患者的治疗，可以改善这一异质患者群体的总体结果。 发改委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-学习)，全面的研究操作支持，最先进的数据 管理和集成系统，以及卓越的行政支持。我们的通信基础设施 将提供公共和私人网站以及社交媒体存在，以有效地传播 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- 友好的高级数据管理和集成系统，包括基于Web的调查、数据访问 条目、研究管理(包括全面报告、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。我们的研究工作和 管理团队将通过促进会议，为BACPAC研究计划提供坚实的基础， 协作性文件准备、法规遵从性跟踪以及摘要和出版支持 BACPAC联盟的准备工作。综合起来，这一综合结构将为 技术评估、征求患者意见和公用事业，以及评估高影响 通过创新的设计和健全的临床试验实施干预措施，导致有效 慢性下腰痛患者的个性化治疗方法。

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.