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.

摘要 美国国立卫生研究院（NIH）创建了帮助结束成瘾长期（HEAL）计划，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进行的疾病疼痛管理试验 协议（UG 3/UH 3，需要临床试验）已发布;预计将选出两个奖项 通过NIH HEAL疼痛管理有效性研究网络（ERN）进行试验。两项试验 将由不同的机制管理。将管理首次试验（以下简称初步试验） 类似于正在进行的五项HEAL ERN试验。这三个HEAL ERN资源中心将作为一个综合的 提供临床协调中心（CCC）支持的基础设施（杜克/范德比尔特），数据协调中心 (DCC)支持（犹他州）和生物统计学支持（霍普金斯/塔夫茨）。第二次审判（以下简称 次要试验）将由犹他州大学管理，以获得CCC和DCC支持。对于两次审判犹他州 将提供单一机构审查委员会（sIRB）服务。除了镰状细胞试验，这种补充剂 还涵盖犹他州对HEAL通用数据元素（CDE）计划的为期一年的支持。迄今所作的努力 由美国国家神经疾病研究所领导的CDE项目， 中风（NINDS）。国家药物滥用研究所（NIDA）领导阿片类药物部门， 努力本CDE补充申请涵盖了HEAL CDE团队在大学开展的工作 犹他州公司支持三项主要活动：（1）CDE文件准备（NINDS），（2）HEAL CDE计划 行政业务（NINDS），（3）OUD研究所用工具的调查（NIDA）。大学 犹他州的HEAL ERN资源中心正在请求一份行政补充，以支持NIH 如上文所述的HEAL倡议。该补编将支持以下具体目标： 具体目标1.为主要镰状细胞试验提供数据协调中心支持，与其他合作伙伴合作 ERN资源中心以与当前五项ERN试验相同的方式，详见母基金。 具体目标2。为继发性镰状细胞病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研究所用仪器的调查。