The Johns Hopkins Translational Science Team for the ET-CTN

描述（由申请人提供）：约翰霍普金斯大学NCI实验治疗临床试验网络（ET-CTN）的转化科学团队（JH-TST）将在临床高效，符合法规和科学严格的合作研究环境中评估有希望的恶性疾病患者新疗法。所有入组患者的分子特征将是标准的。在早期试验的坚实基础上，我们从参与《孢子》、《R01》、《P01》和《U01》项目的研究人员中组建了一支互动的跨学科团队。我们的JH-TST有六个目标：目标1：作为团队成员，积极合作地为ET-CTN做出贡献；目的2：及时开展新型抗癌药物信息性的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，探索药物暴露相关指标与临床、毒理学和生物学终点之间的药代动力学(PK) -药效学（成像和生物标志物）和药物基因组学关系；目的4：在“药物机制证明”的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进行进一步评估。目标5：维持当前的临床试验基础设施，并符合监管标准，以确保对参加早期临床试验的患者提供高质量的护理，并及时与其他研究者和相关方共享数据。和。目标6：培养下一代药物研发人员。通过这些目标，并注重UM1参与者之间的团队科学和合作，JH-TST致力于ET-CTN的成功。我们的团队平均每年有120名患者接受NCI UOl支持的试验。我们预计我们将很容易达到每年50例患者的要求。我们将支持CIRB的早期阶段，并遵守运营效率工作组的其他指标，以确保及时启动、完成和传播我们的调查结果。

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.