The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies

约翰·霍普金斯大学转化科学团队和 ETCTN 研究联盟

• 批准号: 10784843
• 负责人: Michael A Carducci
• 金额: $ 183.64万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-03-13 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10784843
• 关键词: Acceleration; Biological; Biological Assay; Biological Markers; Biopsy Specimen; Cancer Center; Cancer Patient; Cancer Therapy Evaluation Program; Characteristics; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Collection; Comprehensive Cancer Center; Development; Discipline; Disease; Drug resistance; Educational Activities; Eligibility Determination; Environment; Evaluation; Evolution; Fostering; Goals; Good Clinical Practice; Grant; Image; Immunologic Monitoring; Infrastructure; Institution; Intervention; Investigational Therapies; Kimmel Cancer Center at the Thomas Jefferson University; Laboratories; Laboratory Study; Lead; Leadership; Letters; Location; Malignant Neoplasms; Medical; Memorial Sloan-Kettering Cancer Center; Mentors; Methodology; Molecular; NCI-Designated Cancer Center; National Clinical Trials Network; New Agents; Organizational Affiliation; Participant; Pathologist; Pathway interactions; Patient Selection; Patients; Pharmacodynamics; Phase; Phase I Clinical Trials; Protocols documentation; Quality of Care; Research; Research Personnel; Resource Sharing; Resources; Rural; Science; Site; Statistical Data Interpretation; Team Process; Toxic effect; Training; Translating; Translational Research; Universities; University of Virginia Cancer Center; Wisconsin; assay development; biomarker development; biomarker validation; cancer clinical trial; career; clinical care; clinical development; clinical investigation; clinical translation; data sharing; design; drug development; drug sensitivity; early phase clinical trial; early phase trial; experience; innovation; interest; meetings; member; molecular subtypes; next generation; novel; novel anticancer drug; novel therapeutics; participant enrollment; patient population; radiologist; rare cancer; response; stem; success; trial design

With the evolution of the Experimental Therapeutics Clinical Trials Network (ETCTN), the Johns Hopkins Translational Science Team (JHTST) expanded in 2016 by bringing 5 (now 6) Affiliate Organizations (AO) under our Lead Academic Organization (LAO) with the goal to enhance and accelerate our collective contribution to the drug development efforts of the NCI. We have organized a comprehensive and cohesive infrastructure that can conduct high-quality clinical trials evaluating novel anticancer agents, in combinations, in molecularly selected patient populations, or rare tumor sites. Our infrastructure stems from the need to be clinically efficient, regulatory compliant and scientifically rigorous in our approach as we collaborate as network members within the ETCTN. Our infrastructure consists of seven experienced NCI-designated Cancer Centers: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Emory Winship Cancer Institute, Georgetown Lombardi Comprehensive Cancer Center, Sidney Kimmel Cancer Center at Thomas Jefferson University, Memorial Sloan Kettering Cancer Center, University of Virginia Cancer Center, and University of Wisconsin Carbone Cancer Center. This collection of Centers brings together many unique discovery strengths, diverse patient volumes, and locations both urban and rural. We will focus on 4 Specific Aims: Aim 1- To lead and maintain a clinical trial consortium that will support cancer clinical trials from Phase 1 initiation through proof-ofactivity and foster seamless Phase 2 clinical development of NCI CTEP IND agents; Aim 2- To actively participate and engage disease-focused clinical investigators in the ETCTN by promoting accrual to a range of ETCTN studies led by other LAO/AO members; Aim 3- To incorporate and implement innovative correlative and biological laboratory studies in the context of or as eligibility for participation in early phase clinical studies that enhance our understanding of determinants of toxicity and response that will be used for further definitive practice-changing clinical trial evaluation; and Aim 4- To train the next generation of investigators in drug development. With 7 Centers within our Consortium, we anticipate no problem in meeting the grant metrics of 100 accruals per year, submitting enough LOI concepts to have 6 new studies approved each year, functioning as a network by having Disease-Focused Clinical Investigators champion ETCTN studies at each Site across disease sites, and to provide opportunities to engage and train early career investigators in drug development. We anticipate that our contributions within the ETCTN will impact the clinical care of cancer patients.

随着实验治疗学临床试验网络（ETCTN）的发展，约翰霍普金斯大学