Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)

儿童和成人创新试验中心 (TRIDENT)

• 批准号: 10679811
• 负责人: DANIEL K. BENJAMIN
• 金额: --
• 依托单位: DUKE UNIVERSITY
• 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 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10679811
• 关键词: Adult; Biostatistics Core; Child; Clinical; Clinical Trials; Collaborations; Data; Data Coordinating Center; Funding; Future; Helping to End Addiction Long-term; Infrastructure; Institutes; Institutional Review Boards; Leadership; Longitudinal Studies; National Center for Advancing Translational Sciences; Network-based; Opioid; Pain; Pain management; Protocols documentation; Public Health; Research Personnel; United States National Institutes of Health; Universities; Utah; Work; cohesion; design; effectiveness research; innovation; opioid epidemic; trial design

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.

抽象的 开发了长期（治愈）倡议的帮助结束成瘾的倡议，以确定科学解决方案 国家阿片类药物公共卫生危机尽快。作为该计划的一部分，NIH治愈痛苦 管理有效性研究网络（Heal Pain ERN）将使用NCAT试验的基础架构 创新网络可提供科学指导和治疗疼痛试验的协调。具体来说， 杜克/范德比尔特，犹他大学和约翰·霍普金斯/塔夫特的三个试验创新中心（TICS）将 为临床协调中心（CCC），数据协调中心（DCC）和 治愈疼痛的生物统计学核心。将选择五个治疗疼痛ERN试验，这将需要充分 治愈疼痛的支持ERN CCC，DCC和生物统计学核心。此外，基于网络的治疗 MFMU，NCORP和PRISM内的主动项目将需要部分选择从治愈疼痛中选择 ERN CCC，DCC和生物统计学核心。 公爵/范德比尔特审判创新中心有望： 具体目标1。提供临床试验领导和专业知识，研究和协议设计的帮助，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。作为治疗疼痛试验的临床协调中心（CCC）。 具体目标3。为两个治疗疼痛的单一IRB支持ERN试验。 特定目标4。与MFMU，Prism和NCORP Heal Initiative项目合作，并提供特定 项目调查人员，NCAT，项目协调中心和资金的帮助 研究所。 通过完成这些特定目标，我们将协调治疗研究以实现重大创新 在试验设计和执行中，包括：合并和重用有价值的数据，实施效率， 调查团队之间共享痛苦的专业知识，以及将三个抽动作为一个凝聚力单位的整合， 用于未来的审判实施。

项目成果

Safety, Effectiveness and Exposure-response of Micafungin in Infants: Application of an Established Pharmacokinetics Model to Electronic Health Records.

米卡芬净在婴儿中的安全性、有效性和暴露反应：已建立的药代动力学模型在电子健康记录中的应用。

• DOI: 10.1097/inf.0000000000002045
• 发表时间: 2019
• 期刊: The Pediatric infectious disease journal
• 作者: Rivera-Chaparro,NazarioD;Ericson,Jessica;Wu,Huali;Smith,PBrian;Clark,ReeseH;BenjaminJr,DanielK;Cohen-Wolkowiez,Michael;Greenberg,RachelG
• 通讯作者: Greenberg,RachelG

Community SARS-CoV-2 Surge and Within-School Transmission.

• DOI: 10.1542/peds.2021-052686
• 发表时间: 2021-10
• 期刊: PEDIATRICS
• 影响因子: 8
• 作者: Zimmerman, Kanecia O.;Brookhart, M. Alan;Kalu, Ibukunoluwa C.;Boutzoukas, Angelique E.;McGann, Kathleen A.;Smith, Michael J.;Panayotti, Gabriela M. Maradiaga;Armstrong, Sarah C.;Weber, David J.;Moorthy, Ganga S.;Benjamin, Daniel K., Jr.
• 通讯作者: Benjamin, Daniel K., Jr.

In-Person Instruction and Educational Outcomes of K-8 Students During the COVID-19 Pandemic.

COVID-19 大流行期间 K-8 学生的面对面教学和教育成果。

• DOI: 10.1542/peds.2022-060352l
• 发表时间: 2023
• 期刊: Pediatrics
• 影响因子: 8
• 作者: Uthappa,DiyaM;Pak,Joyce;McGann,KathleenA;Brookhart,MAlan;McKinzie,Kaylee;Abdelbarr,Mariam;Cockrell,Jed;Hickerson,Jesse;Armstrong,Sarah;D'Agostino,EmilyM;Weber,DavidJ;Kalu,IbukunoluwaC;Benjamin,DanielK;Zimmerman,KaneciaO

Trends in Pediatric Emergency and Inpatient Healthcare Use for Mental and Behavioral Health Among North Carolinians During the Early COVID-19 Pandemic.

COVID-19 大流行早期期间，北卡罗来纳州居民心理和行为健康方面的儿科急诊和住院医疗保健使用趋势。

• DOI: 10.1093/jpids/piad092
• 发表时间: 2023
• 期刊: Journal of the Pediatric Infectious Diseases Society
• 影响因子: 3.2
• 作者: Sielaty,Rachel;Boutzoukas,AngeliqueE;Zimmerman,KaneciaO;Caison,Bria;Charles,CatherineO;CoyneSmith,Taran;Darden,Toni;Overman,RobertA;BenjaminJr,DanielK;Brookhart,MAlan
• 通讯作者: Brookhart,MAlan

Endotoxin content in neonatal formulas, fortification, and lactoferrin products: association with outcomes and guidance on acceptable limits.

• DOI: 10.1007/s10534-022-00487-1
• 发表时间: 2023-06
• 期刊: BIOMETALS
• 影响因子: 3.5
• 作者: Kaufman, David A.;Perks, Patti H.;Greenberg, Rachel G.;Jensen, David
• 通讯作者: Jensen, David