The Chesapeake-Ohio Pharmacokinetics Core for The ETCTN

ETCTN 的切萨皮克-俄亥俄药代动力学核心

• 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
• 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

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、有效的 生物分析服务，设计临床药理学研究并将其整合到临床方案中 实验治疗药物临床试验网络的开发、样本分析和数据解释 （ETCTN）。ChOP-KC由约翰霍普金斯大学分析药理学中心（俄亥俄州）组成 州立大学药物分析共享资源和马里兰州大学翻译中心 药ChOP-KC的成立是为了最大限度地利用专业知识，基础设施和能力，并确保 有足够的能力实现提供世界级生物分析和临床药理学支持的目标 包括每年分析多达约7，500份药代动力学（PK）样本。我们 组建了一个由高度合作的临床和转化药理学家组成的互动团队（Drs. 米歇尔·鲁德克（mPI），沙琳·贝克（mPI），米奇·菲尔普斯和亚历克斯·斯派瑞布姆），药物计量学家（博士。 Phelps和Joga Gobburu）和统计学家（加里罗斯纳博士）在抗癌药物方面有着坚实的基础 发展我们将利用我们丰富的药理学经验来支持ETCTN的研究设计， 分析开发、生成、分析和解释高质量数据，以提高评估效率 和开发新的癌症疗法，并积极影响癌症患者的临床护理。的 ChOP-KC在执行期间提供临床药理学和药物开发支持方面经验丰富 早期临床试验，并在各种NCI合作组织中拥有广泛的合作记录 协议资助的实体，包括ETCTN（UM 1CA 186691和UM 1CA 186712）和相关项目 团队，艾滋病联盟（UM 1CA 121947）和成人脑肿瘤联盟 （UM 1CA 137443），除了支持化疗药物启动的试验和非临床癌症药物开发外， 在各自的机构和国家。具体目标是：1）提供最先进的良好实验室 规范（GLP）-定量生物液体中抗癌药物和代谢物的质量评价; 2） 通过提供临床药理学专业知识来开发，在NCI ETCTN中协作并积极做出贡献 临床试验方案;和3）提供药代动力学/药效学数据分析和解释， 支持安全有效的临床药物开发决策。ChOP-KC期待着申请 他们的集体专业知识，有利于ETCTN临床试验，并加快实验性治疗剂 发展