HEAL ERN: Data Coordinating Resource Center

HEAL ERN：数据协调资源中心

• 批准号: 10709596
• 负责人: Jonathan Michael Dean
• 金额: $ 312.11万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-23 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10709596
• 关键词: Acute pain management; Award; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Network; Collaborations; Collection; Common Data Element; Data; Data Analyses; Data Collection; Data Set; Databases; Deposition; Development; Dose; Funding; Future; Helping to End Addiction Long-term; Infrastructure; Institution; Institutional Review Boards; Meta-Analysis; Monitor; National Center for Advancing Translational Sciences; Nature; Opiate Addiction; Opioid; Outcome; Pain management; Phase; Preparation; Principal Investigator; Process; Protocols documentation; Public Health; Publications; Quality Control; Randomized; Regimen; Reporting; Research; Research Personnel; Resources; Risk Assessment; Risk Reduction; Safety; Sickle Cell Anemia; Speed; System; Testing; Training; Translational Research; U-Series Cooperative Agreements; United States National Institutes of Health; Universities; Utah; Work; Writing; addiction; chronic pain; comparative effectiveness trial; data ecosystem; data management; data sharing; design; effectiveness research; innovation; prevention effectiveness trial; programs; recruit; repository; response; success

Project Summary The NIH created the Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. As part of the HEAL initiative, the HEAL Effectiveness Research Network (ERN) was established to conduct comparative effectiveness trials for prevention and management of pain, while reducing risk of addiction. Five ERN trials have been implemented with data coordination support from the University of Utah Trial Innovation Center. This proposal is written in response to RFA-TR-22-012 to provide continued support for these five trials, as well as two additional trials that may be funded in response to RFA-AT-22- 005 (“HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement”). The University of Utah is responding to be the Data Coordination Resource Center (DCRC). We will continue to work collaboratively with each ERN study team and the other HEAL ERN Resource Centers to 1) develop, implementand monitor the ERN trials; 2) help respond to issues/protocol changes that emerge during trial implementation and initiate timely necessary changes to assure trial success; 3) provide collection and analysis of data; and 4) assist with timely publication of study results. Our application has three Specific Aims: 1. Work with ERN investigators and other HEAL ERN Resource Centers to provide collaborative clinical trial expertise and assistance in study and protocol design, single IRB, study implementation and management, accrual of subjects, interim study reporting, final study analyses, and assistance with timely publication and dissemination of study results. 2. Provide comprehensive data manage- ment for current and new ERN trials, including database and data collection systems, data management plans, data risk assessment and quality control, implementation of randomization, assistance with Data Safety Monitor- ing Board (DSMB) reports, and training for using the data collection systems. 3. Facilitate sharing of data from HEAL/ERN trials by incorporating HEAL Common Data Elements(CDEs) into protocols, continuing to support NIH program staff in development of HEAL CDEs, continued participation in the HEAL Collective Board, and preparation of final data sets suitable for deposit in NIH-designated repositories for incorporation into the HEAL Data Ecosystem. Our collaboration with ERN investigators and integration with the other Resource Centers will maximize the likelihood of successful and timely completion of the HEAL ERN clinical trials, leading to translation of research findings to the effective management of acute and chronic pain, while minimizing addictive opioid dosing regi- mens.

项目摘要 NIH创造了帮助长期（治愈）倡议的帮助，以加快科学解决方案 国家阿片类药物公共卫生危机。作为Heal倡议的一部分，Heal有效性研究网络 建立（ERN）以进行预防和管理疼痛的比较有效性试验，而 降低成瘾的风险。在数据协调支持的支持下，已实施了五项ERN试验 犹他大学试用创新中心。该建议是根据RFA-TR-22-012的回应来编写的 持续支持这些五项试验，以及针对RFA-AT-22-的另外两个试验，这些试验可能会资助 005（“治愈倡议：利用疼痛管理有效性的镰状细胞疾病疼痛管理试验 研究网络合作协议”）。犹他大学正在回应数据协调 资源中心（DCRC）。 我们将继续与每个ERN学习团队和其他HEN ERN资源合作合作 中心至1）开发，实施和监视ERN试验； 2）帮助回应问题/协议更改 在实施试验期间出现并启动及时的必要更改，以确保审判成功； 3）提供 数据收集和分析； 4）协助及时发布研究结果。 我们的应用程序具有三个特定的目的：1。与ERN调查人员和其他Heal资源一起工作 中心提供协作临床试验专业知识和研究和协议设计的协助，单一IRB， 研究实施和管理，受试者的准确性，临时研究报告，最终研究分析和 协助及时出版和分发研究结果。 2。提供全面的数据管理 - 用于当前和新的ERN试验，包括数据库和数据收集系统，数据管理计划， 数据风险评估和质量控制，随机化的实施，协助数据安全监控器 - ING板（DSMB）报告和使用数据收集系统的培训。 3。促进共享数据 通过将公共数据元素（CD）纳入协议中，治愈/ERN试验，继续支持 NIH计划的工作人员正在开发Heal CDES，继续参与Heal Collective Board，以及 准备最终数据集适用于NIH指定的公司中的存款 数据生态系统。 我们与ERN调查人员的合作以及与其他资源中心的集成将最大化 成功并及时完成HEL ERN临床试验的可能性，导致研究翻译 发现有效治疗急性和慢性疼痛，同时最大程度地减少了阿片类药物的剂量治疗 男士。