The Johns Hopkins Translational Science Team for the ET-CTN

描述(由申请者提供)：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、符合法规和严格科学的合作研究环境中评估针对恶性肿瘤患者的有前景的新疗法。所有入选患者的分子特征将是标准的。在进行早期试验的坚实基础上，我们从参与孢子、R01、P01和U01项目的研究人员池中组建了一个互动和跨学科的团队。我们的JH-TST有六个目标：AIM1-作为团队成员积极协作地参与ET-CTN。目标2-及时进行新型抗癌药物的L/LI信息期临床试验。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，探索药物暴露的相关指标与临床、毒理和生物终点之间的药代动力学(PK)-药效(成像和生物标记物)和药物基因组学关系；目标4-在“药物机制证明”早期研究中实施相关的生物实验室研究，以加强我们对毒性和反应的决定因素的了解，结合PK关系的评估，将被用于选择药物剂量和进一步评估的时间表。目标5-维持一个最新的、符合法规标准的临床试验基础设施，以确保对登记参加早期临床试验的患者的高质量护理，并与其他研究人员和感兴趣的各方提供迅速的数据共享。目标6--培训药物开发方面的下一代调查人员。通过这些目标，并以团队科学和UM1参与者之间的协作为重点，JH-TST致力于ET-CTN的成功。我们的团队在NCI UOL支持的试验中平均每年有120名患者。我们预计，我们将轻松满足所需的50名患者/年应计费用。我们将支持早期CIRB，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。 相关性：我们的团队将继续通过以UM1为基础的项目团队为NCI的药物开发努力做出长期贡献。我们预计，我们在该网络中的贡献将影响癌症患者的临床护理。我们期待通过我们的ECOG-ACRIN联盟加强与国家临床试验网络(NCTN)的互动，从ET-CTN的努力中取得成功。

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.