The Chesapeake-Ohio Pharmacokinetics Core for The ETCTN

ETCTN 的切萨皮克-俄亥俄药代动力学核心

基本信息

批准号：
10361549
负责人：
Sharyn D Baker
金额：
$ 50.92万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-03-10 至 2026-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10361549
关键词：
AIDS Malignancy Consortium Adult Analytical Chemistry Antineoplastic Agents Beds Biological Brain Neoplasms Cancer Patient Clinical Clinical Drug Development Clinical Investigator Clinical Pharmacology Clinical Protocols Clinical Trials Clinical Trials Design Clinical Trials Network Clinical trial protocol document Collaborations Conduct Clinical Trials Data Data Analyses Decision Making Development Dose Drug Exposure Drug Interactions Drug Kinetics Ensure Environment Evaluation Foundations Funding Future Generations Genetic Genetic Polymorphism Goals Individual Infrastructure Institution Investigational Therapies Liquid substance Malignant Neoplasms Maryland Mediating Ohio Outcome Pharmaceutical Preparations Pharmacodynamics Pharmacology Pharmacology Study Reporting Research Design Resource Sharing Risk Sampling Schedule Services Solid Source Specific qualifier value Specimen Testing Time Toxic effect U-Series Cooperative Agreements Universities Validation Variant analytical method appropriate dose assay development cancer clinical trial cancer therapy career clinical care demographics design drug development early phase clinical trial experience good laboratory practice investigator-initiated trial method development novel pharmacometrics protocol development sample collection therapeutic development translational medicine translational study trial design

项目摘要

The Chesapeake-Ohio Pharmacokinetics Core (ChOP-KC) will provide state-of-the-art and efficient bioanalytical service, design and integration of clinical pharmacology studies into clinical protocol development, sample analysis, and data interpretation to the Experimental Therapeutics Clinical Trials Network (ETCTN). The ChOP-KC consists of the Johns Hopkins University Analytical Pharmacology Core, The Ohio State University Pharmacoanalytical Shared Resource, and the University of Maryland Center for Translational Medicine. The ChOP-KC was formed to maximize expertise, infrastructure, and capabilities and to ensure adequate capacity to achieve the goal of providing world-class bioanalytical and clinical pharmacology support to the ETCTN, including analysis of up to approximately 7,500 pharmacokinetic (PK) specimens per year. We have assembled an interactive team of highly collaborative clinical and translational pharmacologists (Drs. Michelle Rudek (mPI), Sharyn Baker (mPI), Mitch Phelps and Alex Sparreboom), pharmacometricians (Drs. Phelps and Joga Gobburu), and statistician (Dr. Gary Rosner) that have a solid foundation in anticancer drug development. We will utilize our extensive pharmacology experience to support the ETCTN with study design, assay development, generation, analysis, and interpretation of high-quality data to enhance efficient evaluation and development of novel cancer therapies and to positively impact the clinical care of cancer patients. The ChOP-KC is experienced in providing clinical pharmacology and drug development support during the conduct of early phase clinical trials and has an extensive track-record of collaboration within various NCI Cooperative Agreements funded entities, including the ETCTN (UM1CA186691 and UM1CA186712) and associated Project Teams, AIDS Malignancy Consortium (UM1CA121947), and the Adult Brain Tumor Consortium (UM1CA137443), in addition to supporting investigator-initiated trials and non-clinical cancer drug development at their respective institutions and nationally. Specific Aims are: 1) To provide state-of-the-art, Good Laboratory Practice (GLP)-quality evaluations to quantitate anticancer drugs and metabolites in biological fluids; 2) To contribute collaboratively and actively in the NCI ETCTN by providing clinical pharmacology expertise to develop clinical trial protocols; and 3) To provide pharmacokinetic/pharmacodynamic data analysis and interpretation to support decision-making for safe and efficient clinical drug development. The ChOP-KC looks forward to applying their collective expertise to benefit ETCTN clinical trials and accelerate experimental therapeutic agent development.

Chesapeake-Ohio药代动力学核心（Chop-KC）将提供最先进的效率临床药理学研究中的生物分析服务，设计和整合到临床方案中开发，样本分析和对实验治疗临床试验网络的数据解释（ETCTN）。 Chop-KC由约翰霍普金斯大学分析药理学核心，俄亥俄州组成州立大学药物分析共享资源和马里兰大学翻译中心药品。形成了Chop-KC，以最大程度地提高专业知识，基础设施和功能，并确保足够的能力来实现提供世界一流的生物分析和临床药理学支持的目标到ETCTN，包括每年大约7,500个药代动力学（PK）标本的分析。我们已经组建了一个由高度协作的临床和转化药理学家组成的互动团队（Drs。 Michelle Rudek（MPI），Sharyn Baker（MPI），Mitch Phelps和Alex Sparreboom），药房（Drs。 Phelps和Joga Gobburu）和统计学家（Gary Rosner博士）在抗癌药物中具有坚实的基础发展。我们将利用我们丰富的药理学经验来支持ETCTN，以研究设计，测定对高质量数据的开发，生成，分析和解释，以增强有效的评估以及新型癌症疗法的发展，并积极影响癌症患者的临床护理。这 Chop-KC在行为期间提供了临床药理学和药物开发支持方面的经验早期临床试验和各种NCI合作社中的合作记录广泛协议资助的实体，包括ETCTN（UM1CA186691和UM1CA186712）和相关项目团队，艾滋病恶性财团（UM1CA121947）和成人脑肿瘤财团（UM1CA137443），除了支持研究者发起的试验和非临床癌症药物开发外在各自的机构和全国范围内。具体目标是：1）提供最先进的良好实验室实践（GLP） - 质量评估，以定量生物流体中的抗癌药物和代谢产物； 2）到通过提供临床药理学专业知识来开发NCI ETCTN，在NCI ETCTN中进行协作和积极贡献临床试验方案； 3）提供药代动力学/药效数据分析和解释支持决策，以实现安全有效的临床药物开发。 Chop-KC期待申请他们的集体专业知识，以使ETCTN临床试验受益并加速实验治疗剂发展。