HEAL Sickle Cell and CDE Supplement

HEAL 镰状细胞和 CDE 补充剂

• 批准号: 10888874
• 负责人: Jonathan Michael Dean
• 金额: $ 208.14万
• 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/10888874
• 关键词: Administrative Supplement; Arm Pain; Award; Biometry; Clinical; Clinical Trials; Common Data Element; Data Coordinating Center; Helping to End Addiction Long-term; Infrastructure; Institutional Review Boards; National Institute of Drug Abuse; National Institute of Neurological Disorders and Stroke; Opioid; Pain management; Preparation; Public Health; Resources; Services; Sickle Cell; Sickle Cell Anemia; Speed; Surveys; U-Series Cooperative Agreements; United States National Institutes of Health; Universities; Utah; Work; arm; effectiveness research; operation; parent grant; programs

Abstract The NIH has 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, RFA-AT-23-002 HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement (UG3/UH3, Clinical Trial Required) was posted; and it is anticipated that two awards will be selected to conduct trials through the NIH HEAL Pain Management Effectiveness Research Network (ERN). The two trials will be managed by different mechanisms. The first trial (herein referred to as the primary trial) will be managed similarly to the five ongoing HEAL ERN trials. The three HEAL ERN resource centers will function as an integrated infrastructure to provide clinical coordinating center (CCC) support (Duke/Vanderbilt), data coordinating center (DCC) support (Utah), and biostatistics support (Hopkins/Tufts). The second trial (herein referred to as the secondary trial) will be managed by the University of Utah for both CCC and DCC support. For both trials Utah will provide single institutional review board (sIRB) services. In addition to the Sickle Cell trials, this supplement also covers Utah support for the HEAL Common Data Elements (CDE) Program for one year. Efforts to date on the CDE Program focused on the pain arm of HEAL, led by the National Institute of Neurological Disorders and Stroke (NINDS). The National Institute on Drug Abuse (NIDA) leads the Opioid arm, which is beginning CDE efforts. This CDE supplement request covers work to be performed by the HEAL CDE team at the University of Utah, and supports three main activities: (1) CDE document preparation (NINDS), (2) HEAL CDE program administrative operations (NINDS), and (3) Survey of instruments used by OUD studies (NIDA). The University of Utah HEAL ERN Resource Center is requesting an administrative supplement to enable support of the NIH HEAL initiative as described above. The supplement will support the following specific aims: Specific Aim 1. Provide data coordinating center support for the primary sickle cell trial, working with the other ERN Resource Centers in the same manner as the current five ERN trials, as detailed in the parent grant. Specific Aim 2. Provide comprehensive clinical and coordinating center support for the secondary sickle cell trial. Specific Aim 3. Support the HEAL CDE Project through (1) CDE document preparation, (2) HEAL CDE program administrative operations, and (3) survey of instruments used for OUD studies.

抽象的 美国国立卫生研究院 (NIH) 制定了帮助戒除成瘾长期 (HEAL) 计划，以加快科学解决方案的速度 全国阿片类药物公共卫生危机。作为 HEAL 计划的一部分，RFA-AT-23-002 HEAL 计划：镰状细胞 利用疼痛管理有效性研究网络合作社进行疾病疼痛管理试验 协议（UG3/UH3，需要临床试验）已发布；预计将评选出两个奖项 通过 NIH HEAL 疼痛管理有效性研究网络 (ERN) 进行试验。两次试验 将通过不同的机制进行管理。将管理第一次审判（以下简称初步审判） 与正在进行的五项 HEAL ERN 试验类似。三个 HEAL ERN 资源中心将作为一个综合中心 提供临床协调中心 (CCC) 支持（杜克/范德比尔特）、数据协调中心的基础设施 （DCC）支持（犹他州）和生物统计学支持（霍普金斯/塔夫茨）。二审（以下简称二审） 二级试验）将由犹他大学管理，以获得 CCC 和 DCC 的支持。对于犹他州的两项试验 将提供单一机构审查委员会 (SIRB) 服务。除了镰状细胞试验外，该补充剂 还涵盖犹他州对 HEAL 通用数据元素 (CDE) 计划为期一年的支持。迄今为止的努力 关注由国家神经疾病研究所领导的 HEAL 疼痛部门的 CDE 项目 和中风（NINDS）。国家药物滥用研究所 (NIDA) 领导阿片类药物部门，该部门正在启动 CDE 努力。此 CDE 补充请求涵盖了大学 HEAL CDE 团队要执行的工作 犹他州，并支持三项主要活动：(1) CDE 文件准备 (NINDS)，(2) HEAL CDE 计划 (NINDS)，以及 (3) OUD 研究使用的工具调查 (NIDA)。大学 犹他州 HEAL ERN 资源中心正在请求行政补充，以便为 NIH 提供支持 如上所述的 HEAL 倡议。该增刊将支持以下具体目标： 具体目标 1. 与其他机构合作，为原发性镰状细胞试验提供数据协调中心支持 ERN 资源中心采用与当前五个 ERN 试验相同的方式，如母基金中详述。 具体目标 2. 为次级镰状细胞提供全面的临床和协调中心支持 审判。 具体目标 3. 通过 (1) CDE 文件准备、(2) HEAL CDE 计划支持 HEAL CDE 项目 行政操作；(3) OUD 研究所用工具的调查。