The Johns Hopkins Translational Science Team for the ET-CTN

约翰·霍普金斯大学 ET-CTN 转化科学团队

• 批准号: 8822258
• 负责人: Michael A Carducci
• 金额: $ 90万
• 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 2019-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8822258
• 关键词: American College of Radiology Imaging Network; Antineoplastic Agents; Area; Attention; Biological; Biometry; Cancer Patient; Cancer Therapy Evaluation Program; Clinical; Clinical Pharmacology; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Conduct Clinical Trials; Data; Development; Development Plans; Diagnostic; Disease; Dose; Drug Exposure; Drug Kinetics; Eastern Cooperative Oncology Group; Education; Elderly; Enrollment; Ensure; Environment; Epigenetic Process; Ethnic group; Evaluation; Foundations; Gender; Goals; Grant; Hematologic Neoplasms; Image; Immunotherapy; Information Systems; International; Investigational Drugs; Laboratories; Laboratory Study; Lead; Malignant - descriptor; Molecular; National Clinical Trials Network; Organ; Participant; Patients; Pharmaceutical Preparations; Pharmacodynamics; Pharmacogenomics; Phase; Population; Prior Therapy; Property; Publishing; Quality of Care; Research; Research Infrastructure; Research Personnel; Schedule; Science; Signal Transduction; Solid Neoplasm; Specific qualifier value; Therapeutic Clinical Trial; TimeLine; Toxic effect; Training; Translational Research; antiangiogenesis therapy; base; cancer therapy; clinical care; data management; data sharing; design; drug development; drug mechanism; efficacy evaluation; experience; flexibility; imaging biomarker; indexing; interest; meetings; member; next generation; novel; patient population; phase 1 study; programs; response; success; tumor; working group

DESCRIPTION (provided by applicant): The Johns Hopkins Translational Science Team (JH-TST) for the NCI Experimental Therapeutics Clinical Trials Network (ET-CTN) will evaluate promising new therapies for patients with malignant disease in a clinically efficient, regulatory compliant and scientifically rigorous collaborative research environment. The molecular characterization of all enrolled patients will be standard. Building upon a strong foundation in th conduct of early phase trials, we have assembled an interactive and interdisciplinary Team from a pool of investigators involved in SPORE, R01, P01, and U01 projects. Our JH-TST has six aims: Aim1-To contribute collaboratively and actively in the ET-CTN as a team member.; Aim 2-To conduct informative Phase l/lI clinical trials of novel anti-cancer agents in a timely manner.; Aim 3-To collaborate with ET-CTN teams to perform detailed molecular characterization of novel anti-cancer agents and explore pharmacokinetic (PK) - pharmacodynamic (imaging and biomarkers) and pharmacogenomic relationships between relevant indices of drug exposure and clinical, toxicological, and biological endpoints.; Aim 4-To implement correlative and biological laboratory studies in "proof of drug mechanism" early phase studies in order to enhance our understanding of determinants of toxicity and response that, combined with assessment of PK relationships, will be used to select drug dose and schedule for further evaluation.; Aim 5-To maintain a clinical trial infrastructure that is current and compliant with regulatory standards that assure quality care to patients enrolled on early phase clinical trials a well as provide prompt data sharing with other investigators and interested parties.; and. Aim 6-To train the next generation of investigators in drug development. Through these aims and with a focus on team science and collaboration across UM1 participants, the JH-TST is committed to the success of the ET-CTN. Our Team has averaged 120 patients/year on NCI UOl supported trials. We anticipate that we will easily meet the required 50 patients/year accrual. We will support the Early Phase CIRB and adhere to other metrics of the Operational Efficiency Working Group to assure timely activation, completion, and dissemination of our findings. RELEVANCE: Our Team will continue its long-standing contribution to the drug development efforts of the NCI through UM1-based project teams. We anticipate that our contribution within the Network will impact the clinical care of cancer patients. We anticipate enhanced interactions with the National Clinical Trials Network (NCTN) through our ECOG-ACRIN affiliation to bring forward successes from the efforts of the ET-CTN.

描述（由申请人提供）：NCI实验疗法临床试验网络（ET-CTN）的Johns Hopkins转化科学团队（JH-TST）将评估在临床上有效，调节性符合性和科学严格的协作研究环境中为恶性疾病的患者评估有希望的新疗法。所有入学患者的分子表征将是标准的。在早期试验的强大基础上，我们从参与孢子，R01，P01和U01项目的一群调查人员组合了一个互动和跨学科的团队。我们的JH-TST有六个目标：AIM1作为团队成员在ET-CTN中进行协作和积极贡献。 AIM 2及时对新型抗癌药的临床试验进行信息。 AIM 3与ET-CTN团队合作，对新型抗癌剂进行详细的分子表征，并探索药代动力学（PK） - 药效学（成像和生物标志物）以及药物暴露与临床，毒理学和生物学内点的相关指标之间的药物基因组之间的关系。 AIM 4 TO在“药物机制证明”的早期研究中实施相关和生物实验室研究，以增强我们对毒性和反应决定因素的理解，这些决定因素将与PK关系的评估相结合，可用于选择药物剂量和时间表进行进一步评估。 AIM 5维护临床试验基础设施，该基础设施符合当前的监管标准，该标准可以确保为参加早期临床试验的患者提供优质的护理，并与其他研究人员和感兴趣的人一起提供及时的数据共享。和。目标6培训下一代药物开发研究人员。通过这些目标，并着重于UM1参与者的团队科学和协作，JH-TST致力于ET-CTN的成功。我们的团队在NCI UOL支持试验中平均有120名患者。我们预计我们将轻松满足所需的50名患者/年应计。我们将支持早期CIRB并遵守操作效率工作组的其他指标，以确保及时激活，完成和传播我们的发现。 相关性：我们的团队将通过基于UM1的项目团队继续对NCI的药物开发工作的长期贡献。我们预计我们在网络中的贡献将影响癌症患者的临床护理。我们预计，通过我们的ECOG-ACRIN隶属关系，与国家临床试验网络（NCTN）的相互作用增强，从ET-CTN的努力中带来了成功。