Mentoring in Clinical Pharmacology and Early Phase Trials

临床药理学和早期试验的指导

• 批准号: 10620632
• 负责人: Michael Cohen-Wolkowiez
• 金额: $ 17.77万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-10 至 2024-11-24
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10620632
• 关键词: Adult; Age; Anti-Infective Agents; Award; Biometry; Career Mobility; Child; Childhood; Clinical Pharmacology; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Cohort Studies; Committee Members; Contracts; Data; Data Analyses; Data Set; Development; Doctor of Philosophy; Dose; Drug usage; Educational Status; Elderly; Ensure; Extramural Activities; Faculty; Fellowship; Funding; Funding Mechanisms; Future; Goals; Health Sciences; Individual; Infrastructure; Institution; Investigation; Knowledge; Label; Lead; Licensing; Longevity; Medical; Medicine; Mentors; Mentorship; Methods; Modeling; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; North Carolina; Pathway interactions; Pediatrics; Peer Review; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Pharmacy Schools; Phase; Phase I Clinical Trials; Physicians; Physiology; Population; Positioning Attribute; Pregnant Women; Public Health; Publications; Research; Research Infrastructure; Research Institute; Research Personnel; Research Project Grants; Research Support; Resources; Role; Safety; Science; Scientist; Secure; Services; Therapeutic Agents; Time; Training; Training Programs; Training and Infrastructure; United States National Institutes of Health; Universities; Vulnerable Populations; Work; antimicrobial; base; career; career development; data management; drug development; drug efficacy; early phase trial; educational atmosphere; expectation; experience; improved; interest; investigator training; mid-career faculty; next generation; patient oriented research; pediatric department; pediatrician; pharmacokinetics and pharmacodynamics; professor; programs; recruit; skill acquisition; skills; success; trial design

Historically, >50% of drugs have insufficient labeling to inform physicians on dosing, safety, or efficacy in vulnerable populations including children, pregnant women, and the elderly. Mechanisms requiring the study of new products in vulnerable populations are relatively new and highlight a training gap in junior scientists related to the investigation of therapeutic agents. There is an urgent need for well-trained adult and pediatric investigators with quantitative research skills in clinical pharmacology and clinical trials. In this award, the investigator, Michael Cohen-Wolkowiez, MD, PhD, will prepare adult and pediatric junior scientists for a career in patient-oriented research to bridge this gap in accordance with his own long-term research goals: to improve drug development by establishing proper dosing, safety, and efficacy of drugs used in vulnerable populations. To date, Dr. Cohen-Wolkowiez has achieved early success in training beginning scientists by leveraging every research mechanism for training in clinical pharmacology and clinical trials. Most of these research projects and trainees have been focused on anti-infectives. In this award, he will further expand his training program to include more adult trainees and use several research infrastructures for training. These include funding mechanisms such as the NIAID Phase 1 Clinical Trial Unit (P1CTU) of Anti-Infectives contract, the Pediatric Trials Network (PTN), and the FDA Global Pediatric Clinical Trials Network (GPCTN). The NIAID-sponsored P1CTU is a 10-year contract to conduct early phase studies of anti-infectives at the Duke Phase 1 Clinical Research Unit, which he directs. The NICHD-sponsored PTN, for which the applicant is an Executive Committee Member and PI of several clinical trials within the network, has ~30 ongoing clinical trials that the applicant has used for training of junior investigators. Through this mechanism, the candidate has successfully developed four young investigators who have secured their own NIH funding. The FDA-sponsored GPCTN is a recent mechanism that aims to provide pediatric clinical trial infrastructure to conduct studies for labeling. Additional strengths of Dr. Cohen-Wolkowiez program include the unparalled research infrastructure of the Duke Clinical Research Institute, and a longstanding academic partnership with the renowned University of North Carolina School of Pharmacy. Through this integral partnership, Dr. Cohen-Wolkowiez serves as the Duke Fellowship director of an NIH-sponsored T-32 clinical pharmacology fellowship training program and a pathway for junior investigators to secure PhD or Masters level training in clinical pharmacology.Trainees in clinical pharmacology and clinical trials will be recruited at Duke University to lead research projects. Specifically, the proposed studies, will offer mentees the opportunity to capitalize on the diverse research program that Dr. Cohen-Wolkowiez has developed. Feasibility of the proposed award is shown by Dr. Cohen- Wolkowiez' early success in funding and career development of current trainees at Duke and UNC and by trainees' publication track record; >80 peer-reviewed articles with trainees as first author.

从历史上看，> 50％的药物的标签不足以告知医生的给药，安全性或功效 弱势群体，包括儿童，孕妇和老年人。需要研究的机制 弱势群体中的新产品相对较新，突出了初级科学家的培训差距 与治疗剂的研究有关。迫切需要训练有素的成人和小儿 具有临床药理学和临床试验的定量研究技能的研究者。在这个奖项中， 调查员迈克尔·科恩·沃尔科维斯（Michael Cohen-Wolkowiez），医学博士，将为成人和儿科初级科学家做好准备工作 在以患者为导向的研究中，根据自己的长期研究目标弥合这一差距： 通过在弱势群体中使用的药物的适当给药，安全性和功效来开发药物。 迄今为止，科恩·沃尔科维斯（Cohen-Wolkowiez）博士通过利用每个 临床药理学和临床试验培训的研究机制。这些研究项目中的大多数 学员一直专注于反感染者。在这个奖项中，他将进一步将他的培训计划扩展到 包括更多的成人学员，并使用几个研究基础设施进行培训。这些包括资金 诸如抗侵害剂合同的NIAID 1期临床试验单元（P1CTU）等机制 试验网络（PTN）和FDA全球小儿临床试验网络（GPCTN）。尼亚德赞助 P1CTU是一项为期10年的合同，用于在杜克大学1阶段进行反感染的早期研究 他指导的研究部门。 NICHD赞助的PTN，申请人是高管 该网络中的几项临床试验的委员会成员和PI，有30次正在进行的临床试验， 申请人已用于培训初级调查人员。通过这种机制，候选人已成功 开发了四名年轻的调查人员，他们获得了自己的NIH资金。 FDA赞助的GPCTN是 旨在提供小儿临床试验基础设施以进行标签的研究的最新机制。 Cohen-Wolkowiez博士计划的其他优势包括无准备的研究基础设施 杜克临床研究所，以及与著名大学的长期学术合作伙伴关系 北卡罗来纳州药学院。通过这种整体伙伴关系，科恩·沃尔科维斯博士担任 NIH赞助的T-32临床药理学奖学金培训计划和一个 初级调查人员确保临床药理学的博士学位或硕士水平培训的途径。 临床药理学和临床试验将在杜克大学招募，以领导研究项目。 具体而言，拟议的研究将为受训者提供利用多元化研究的机会 Cohen-Wolkowiez博士开发的计划。拟议奖的可行性由Cohen-博士表明 沃尔科维斯（Wolkowiez 受训者的出版记录； >由学员作为第一作者进行了80次同行评审文章。

项目成果

Physiologically Based Pharmacokinetic Modeling for Trimethoprim and Sulfamethoxazole in Children.

基于生理学的儿童甲氧苄啶和磺胺甲恶唑药代动力学模型。

• DOI: 10.1007/s40262-018-00733-1
• 发表时间: 2019
• 期刊: Clinical pharmacokinetics
• 影响因子: 4.5
• 作者: Thompson,ElizabethJ;Wu,Huali;Maharaj,Anil;Edginton,AndreaN;Balevic,StephenJ;Cobbaert,Marjan;Cunningham,AnthonyP;Hornik,ChristophP;Cohen-Wolkowiez,Michael
• 通讯作者: Cohen-Wolkowiez,Michael

External Evaluation of Two Pediatric Population Pharmacokinetics Models of Oral Trimethoprim and Sulfamethoxazole.

口服甲氧苄啶和磺胺甲恶唑的两种儿童群体药代动力学模型的外部评价。

• DOI: 10.1128/aac.02149-20
• 发表时间: 2021
• 期刊: Antimicrobial agents and chemotherapy
• 影响因子: 4.9
• 作者: Wu,YiShuanS;Cohen-Wolkowiez,Michael;Hornik,ChristophP;Gerhart,JacquelineG;Autmizguine,Julie;Cobbaert,Marjan;Gonzalez,Daniel;BestPharmaceuticalsforChildrenAct—PediatricTrialsNetworkSteeringCommittee
• 通讯作者: BestPharmaceuticalsforChildrenAct—PediatricTrialsNetworkSteeringCommittee

RADx-UP Testing Core: Access to COVID-19 Diagnostics in Community-Engaged Research with Underserved Populations.

• DOI: 10.1128/jcm.00367-23
• 发表时间: 2023-08-23
• 期刊: JOURNAL OF CLINICAL MICROBIOLOGY
• 影响因子: 9.4
• 作者: Narayanasamy, Shanti;Veldman, Timothy H.;Lee, Mark J.;Glover II, William A.;Tillekeratne, L. Gayani;Neighbors, Coralei E.;Harper, Barrie;Raghavan, Vidya;Kennedy, Scott W.;Carper, Miranda;Denny, Thomas;Tsalik, Ephraim L.;Reller, Megan E.;Kibbe, Warren A.;Corbie, Giselle;Cohen-Wolkowiez, Michael;Woods, Christopher W.;Petti, Cathy A.
• 通讯作者: Petti, Cathy A.

A Pharmacoepidemiologic Study of the Safety and Effectiveness of Clindamycin in Infants.

克林霉素在婴儿中的安全性和有效性的药物流行病学研究。

• DOI: 10.1097/inf.0000000000002524
• 发表时间: 2020
• 期刊: The Pediatric infectious disease journal
• 作者: Greenberg,RachelG;Wu,Huali;Maharaj,Anil;Cohen-Wolkowiez,Michael;Tomashek,KayM;Osborn,BlaireL;Clark,ReeseH;Walter,EmmanuelB
• 通讯作者: Walter,EmmanuelB

A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication.

青少年、儿童和婴儿中索利霉素的干血斑分析：简短的交流。

• DOI: 10.1097/ftd.0000000000000670
• 发表时间: 2019
• 期刊: Therapeutic drug monitoring
• 影响因子: 2.5
• 作者: Beechinor,RyanJ;Cohen-Wolkowiez,Michael;Jasion,Theresa;Hornik,ChristophP;Lang,JasonE;Hernandez,Robert;Gonzalez,Daniel
• 通讯作者: Gonzalez,Daniel