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Global Pediatric Clinical Trials Network

全球儿科临床试验网络

基本信息

批准号：
10206152
负责人：
Michael Cohen-Wolkowiez
金额：
$ 100万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-25 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10206152
关键词：
Global Pediatric Clinical Trials Network

项目摘要

Failure to label devices and therapeutics for children threatens public health. Performing adequate studies for pediatric labeling, however, poses many challenges. These include a limited number of eligible participants with the disease; study design and operational inefficiencies; ineffective stakeholder engagement; and lack of a robust, pediatric-specific global infrastructure for enrollment. To address this critical unmet need, we will develop the Global Pediatric Clinical Trials Network (G-PCTN), which will support the infrastructure to plan and execute pediatric clinical trials through collaboration with academia, industry, parent/patient advocacy groups, and government agencies. G-PCTN will serve as the coordinating resource for pediatric product development to improve the public health of children. We will utilize the partnership of a fully functioning pediatric clinical trials network and a collaboration of FDA, academic medical centers, industry, patient and family advocacy groups, professional societies and other stakeholders. Under the leadership of Principal Investigators (PIs) Drs. Daniel K. Benjamin, Jr. and Michael Cohen-Wolkowiez, we will establish 3 cores (Network Operations, Patient Engagement, and Scientific Oversight) and 5 clinical study groups that will focus on design, dosing, regulatory/pharmacy, network partnerships, and rare diseases. Both PIs bring complementary skills to lead the network including vision, clinical trial expertise, chairing of large clinical trials networks (National Institute of Child Health and Human Development Pediatric Trials Network, Clinical and Translational Science Awards Trial Innovation Center), industry, and government therapeutics development experience, regulatory strategy, and PK/PD modeling. Together, we will leverage our experience, capacity, regulatory knowledge, and track- record to establish the scientific, operational, and stakeholder engagement infrastructure to plan and complete pediatric clinical studies. We will focus on operational efficiencies and network sustainability with early, systematic, and integrative approaches to pediatric trials. G-PCTN will solidify and expand our established global research site network, employing its infrastructure and resources to support investigators, sponsors, patients, and trainees to conduct clinical trials in children. We will focus on the following specific aims 1) provide strategy and content expertise to increase the success of pediatric product development; 2) provide education and training on best practices, design, and execution of pediatric trials; and 3) establish and manage a sustainable network of sites to execute clinical trials in children. As a result of the efforts of our collaborative G-PCTN, we will establish the required infrastructure to efficiently conduct scientifically sound global pediatric clinical trials. This new infrastructure will be leveraged by different sponsors to generate regulatory-grade quality data and improve pediatric public health.

没有给儿童使用的器械和治疗方法贴上标签威胁着公众健康。进行充分的研究

项目成果

期刊论文数量（14）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Beyond pain control: Outcome and treatment preferences in pediatric migraine.

DOI：
10.1111/head.14315
发表时间：
2022-05
期刊：
HEADACHE
影响因子：
5
作者：
Khayata, Matthew J.;Farley, Samantha;Davis, J. Kelly;Hornik, Christoph P.;Reeve, Bryce B.;Rikhi, Aruna;Gelfand, Amy A.;Szperka, Christina L.;Kessel, Shirley;Pezzuto, Tara;Hammett, Alex;Lemmon, Monica E.
通讯作者：
Lemmon, Monica E.

Pharmacokinetics of Hydroxychloroquine in Pregnancies with Rheumatic Diseases.

风湿病妊娠中羟氯喹的药代动力学。

DOI：
10.1007/s40262-018-0712-z
发表时间：
2019-04
期刊：
Clinical pharmacokinetics
影响因子：
4.5
作者：
Balevic SJ;Green TP;Clowse MEB;Eudy AM;Schanberg LE;Cohen-Wolkowiez M
通讯作者：
Cohen-Wolkowiez M

Bringing research directly to families in the era of COVID-19.

DOI：
10.1038/s41390-020-01260-1
发表时间：
2021-03
期刊：
Pediatric research
影响因子：
3.6
作者：
Balevic SJ;Singler L;Randell R;Chung RJ;Lemmon ME;Hornik CP
通讯作者：
Hornik CP

Pitfalls of using numerical predictive checks for population physiologically-based pharmacokinetic model evaluation.

使用数值预测检查进行基于群体生理学的药代动力学模型评估的缺陷。

DOI：
10.1007/s10928-019-09636-5
发表时间：
2019
期刊：
Journal of pharmacokinetics and pharmacodynamics
影响因子：
2.5
作者：
Maharaj,AnilR;Wu,Huali;Hornik,ChristophP;Cohen-Wolkowiez,Michael
通讯作者：
Cohen-Wolkowiez,Michael

Ten Eleven things to facilitate participation of underrepresented groups in headache medicine research.

十一件事可以促进代表性不足的群体参与头痛医学研究。

DOI：
10.1111/head.14124
发表时间：
2021-06
期刊：
HEADACHE
影响因子：
5
作者：
Begasse de Dhaem, Olivia;Kiarashi, Jessica;Armand, Cynthia E.;Charleston, Larry;Szperka, Christina L.;Lee, Yeonsoo S.;Rajapakse, Thilinie;Seng, Elizabeth K.;VanderPluym, Juliana H.;Starling, Amaal J.
通讯作者：
Starling, Amaal J.