Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)

摘要 帮助结束成瘾长期（HEAL）倡议的制定是为了确定科学的解决方案， 国家阿片类药物公共卫生危机尽快。作为这项倡议的一部分，NIH治愈疼痛 管理有效性研究网络（HEAL Pain ERN）将使用NCATS试验的基础设施 创新网络为HEAL Pain ERN试验提供科学指导和协调。具体地说， 位于杜克/范德比尔特、犹他州和约翰霍普金斯/塔夫茨的三个试验创新中心将 为临床协调中心（CCC）、数据协调中心（DCC）提供集成功能，以及 HEAL Pain ERN的生物统计学核心。将选择五项HEAL Pain ERN试验，这些试验将需要完整的 来自HEAL Pain ERN CCC、DCC和生物统计学核心的支持。此外，基于网络的HEAL MFMU、NCORP和PRISM中的主动性项目将需要“治愈之痛”的部分选择支持 ERN CCC、DCC和生物统计学核心。 杜克/范德比尔特试验创新中心准备： 具体目标1。提供临床试验领导和专业知识，协助研究和方案设计，研究 实施和管理，与其他两个试验创新中心合作。 具体目标2。作为HEAL Pain ERN试验的临床协调中心（CCC）。 具体目标3。为两项HEAL Pain ERN试验提供单一IRB支持。 具体目标4。与MFMU、PRISM和NCORP HEAL倡议项目合作，并提供具体的 项目调查人员、NCATS、项目协调中心和资金要求的援助 院 通过完成这些具体目标，我们将协调HEAL研究，以实现重大创新 在试验设计和执行中，包括：有价值数据的组合和重用，执行效率， 在调查小组之间共享疼痛专业知识，并将三个TIC整合为一个有凝聚力的单位， 供今后试用。

ABSTRACT The Helping to End Addiction Long-term (HEAL) initiative was developed to identify scientific solutions to the national opioid public health crisis as quickly as possible. As part of this initiative, the NIH HEAL Pain Management Effectiveness Research Network (HEAL Pain ERN), will use the infrastructure of the NCATS Trial Innovation Network to provide scientific guidance and coordination of the HEAL Pain ERN Trials. Specifically, the three Trial Innovation Centers (TICs) at Duke/Vanderbilt, University of Utah and Johns Hopkins/Tufts will provide integrated functions for the clinical coordinating center (CCC), data coordinating center (DCC), and biostatistics core for the HEAL Pain ERN. Five HEAL Pain ERN trials will be selected which will require full support from the HEAL Pain ERN CCC, DCC, and biostatistics core. In addition, network-based HEAL initiative projects within the MFMU, NCORP, and PRISM will require partial select support from the HEAL Pain ERN CCC, DCC, and biostatistics core. The Duke/Vanderbilt Trial Innovation Center is poised to: Specific Aim 1. Provide clinical trial leadership and expertise, assistance in study and protocol design, study implementation, and management, in collaboration with the other two Trial Innovation Centers. Specific Aim 2. Serve as the clinical coordinating center (CCC) for the HEAL Pain ERN trials. Specific Aim 3. Provide single IRB support for two HEAL Pain ERN trials. Specific Aim 4. Collaborate with the MFMU, PRISM, and NCORP HEAL initiative projects and provide specific assistance requested by the project investigators, NCATS, project coordinating centers, and the funding institute. Through completion of these specific aims, we will harmonize the HEAL studies to achieve major innovations in trial design and execution, including: combination and reuse of valuable data, efficiencies of implementation, shared pain expertise among investigative teams, and the integration of three TICs as a cohesive unit, poised for future trial implementation.