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 实验治疗临床试验网络 (ET-CTN) 的约翰霍普金斯大学转化科学团队 (JH-TST) 将在临床高效、合规且科学严谨的协作研究环境中评估针对恶性疾病患者的有前景的新疗法。所有入组患者的分子特征都将是标准的。建立在进行早期试验的坚实基础上，我们由参与 SPORE、R01、P01 和 U01 项目的研究人员组成了一个互动的跨学科团队。我们的 JH-TST 有六个目标： 目标 1-作为团队成员在 ET-CTN 中积极协作、做出贡献。目标 2-及时开展新型抗癌药物的信息丰富的 I/I 期临床试验。目标 3-与 ET-CTN 团队合作，对新型抗癌药物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）以及药物暴露相关指标与临床、毒理学和生物学终点之间的药物基因组关系。目标 4-在“药物机制证明”早期研究中实施相关和生物学实验室研究，以增强我们对毒性和反应决定因素的理解，结合 PK 关系的评估，将用于选择药物剂量和时间表以进行进一步评估。目标 5 - 维护最新且符合监管标准的临床试验基础设施，确保为参与早期临床试验的患者提供优质护理，并与其他研究人员和感兴趣的各方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，并重点关注 UM1 参与者之间的团队科学和协作，JH-TST 致力于 ET-CTN 的成功。我们的团队每年平均参与 NCI UOl 支持的试验 120 名患者。我们预计我们将轻松满足每年 50 名患者的需求。我们将支持早期阶段 CIRB 并遵守运营效率工作组的其他指标，以确保及时激活、完成和传播我们的研究结果。 相关性：我们的团队将通过基于 UM1 的项目团队继续为 NCI 的药物开发工作做出长期贡献。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 联盟加强与国家临床试验网络 (NCTN) 的互动，以推动 ET-CTN 的努力取得成功。