HEAL ERN: Data Coordinating Resource Center

HEAL ERN：数据协调资源中心

• 批准号: 10591779
• 负责人: Jonathan Michael Dean
• 金额: $ 60.48万
• 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/10591779
• 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; Risk Assessment; Safety; Sickle Cell Anemia; Speed; System; Testing; Time; Training; Translational Research; Translations; U-Series Cooperative Agreements; United States National Institutes of Health; Universities; Utah; Work; 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.

项目概要 美国国立卫生研究院 (NIH) 发起了帮助戒除成瘾长期 (HEAL) 计划，以加快解决成瘾问题的科学方法 国家阿片类药物公共卫生危机 作为 HEAL 计划的一部分，HEAL 有效性研究网络。 (ERN) 的成立是为了进行预防和管理疼痛的比较有效性试验，同时 在 ERN 的数据协调支持下，已实施了五项降低成瘾风险的试验。 犹他大学试验创新中心撰写此提案是为了回应 RFA-TR-22-012。 继续支持这五项试验，以及可能根据 RFA-AT-22- 的要求资助的另外两项试验 005（“HEAL Initiative：利用疼痛管理有效性进行镰状细胞病疼痛管理试验” 研究网络合作协议”）犹他大学回应称是数据协调。 资源中心（DCRC）。 我们将继续与每个 ERN 研究团队和其他 HEAL ERN 资源合作 中心 1) 开发、实施和监控 ERN 试验；2) 帮助应对以下问题/方案变更： 在实施试验期间出现并及时启动必要的变更以确保试验成功； 数据收集和分析；4) 协助及时发布研究结果。 我们的申请有三个具体目标： 1. 与 ERN 调查员和其他 HEAL ERN 资源合作 提供协作临床试验专业知识以及研究和方案设计、单一IRB、 研究实施和管理、受试者应计、中期研究报告、最终研究分析，以及 协助及时发布和传播研究结果。 2. 提供全面的数据管理。 当前和新的 ERN 试验的支持，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、数据安全监控的协助- 委员会 (DSMB) 报告以及使用数据收集系统的培训 3. 促进数据共享。 通过将 HEAL 通用数据元素 (CDE) 纳入协议中来继续支持 HEAL/ERN 试验 NIH 项目工作人员开发 HEAL CDE，继续参与 HEAL 集体委员会，以及 准备适合存放在 NIH 指定存储库中的最终数据集，以便纳入 HEAL 数据生态系统。 我们与 ERN 研究人员的合作以及与其他资源中心的整合将最大限度地提高 成功及时完成 HEAL ERN 临床试验的可能性，从而实现研究转化 有效管理急性和慢性疼痛，同时最大限度地减少成瘾性阿片类药物剂量的研究结果 男士。