Administrative Supplements for NCI P30 Cancer Center Support Grants The Early Drug Development Opportunity Program (EDDOP)

NCI P30 癌症中心支持拨款早期药物开发机会计划 (EDDOP) 的行政补充

• 批准号: 10677088
• 负责人: JOSEPH P. UBERTI
• 金额: $ 7.5万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-12 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10677088
• 关键词: Administrative Supplement; Advanced Malignant Neoplasm; Affect; Basic Science; Cancer Center Support Grant; Cancer Control; Clinical Research; Clinical Trials; Collection; Compassion; Conflict of Interest; Development; Drug Kinetics; Education; Enrollment; Ensure; Fostering; Institutes; Intervention Trial; Investigation; Lead; Malignant Neoplasms; Methods; Mission; Molecular Target; National Clinical Trials Network; Outcome; Patient Care; Patients; Pharmacy facility; Population Research; Procedures; Regulation; Research; Research Institute; Research Personnel; Site; Training; Translational Research; Work; cancer care; drug development; early phase clinical trial; exome; human subject protection; patient safety; programs; quantitative imaging; ranpirnase; standard of care; transcriptome; tumor

The Karmanos Cancer Institute (KCI) is an NCI-designated Comprehensive Cancer and works to foster clinical trial development and conduct. In this capacity, we participate in many trials through the National Clinical Trials Network (NCTN) and are a Lead Academic Participating Site (LAPS). Part of our effort to conduct early clinical trials involved our participation in CATCH-UP.2020. The KCI joined the CATCH-UP NCI program in August 2020. The first trials through this mechanism opened the end of September 2020. We had 19 trials opened under CATCH-UP and 11 are still open to accrual. In the 13 years since the first trial opened, we have enrolled 24 patients. Hence, we should readily be able to enroll at least 5 patients per year with EDDOP support. We now have about 189 interventional trials open to accrual and have in place all the needed procedures to ensure human subjects protection, follow trial methods, and track the studies. We have training mechanisms in place for investigators and staff and ensure that no conflict of interest will affect the trial outcome. Our cores provide for the collection of biospecimens, pharmacokinetic analysis, and quantitative imaging. We routinely do whole exome and transcriptome analysis of tumors from patients with advanced cancer to look for molecular targets are part of our standard of care and for trial identification. Trials are audited and tracked to ensure that accrual is robust and methods are being followed. We have a separate investigational pharmacy to oversee the ordering, storage, dispensing, transport, and tracking of investigational agents. All our procedures are done to meet local, state, and federal regulations and ensure patient safety and the collection of validated trial results.

Karmanos 癌症研究所 (KCI) 是 NCI 指定的综合癌症研究所，致力于促进临床研究 试验开发和实施。以这种身份，我们通过国家临床试验参与了许多试验 网络 (NCTN)，并且是领先的学术参与网站 (LAPS)。我们努力进行早期临床的一部分 试验涉及我们参与 CATCH-UP.2020。 KCI 于 2020 年 8 月加入 CATCH-UP NCI 计划。 通过该机制的首次试验于 2020 年 9 月底开始。我们已根据该机制开展了 19 项试验 CATCH-UP 和 11 仍可累积。自第一次试验开始以来的 13 年里，我们已经招募了 24 名 患者。因此，我们应该能够在 EDDOP 支持下每年招募至少 5 名患者。我们现在 约有 189 项干预试验可供应计，并已制定所有必要的程序以确保 人类受试者保护、遵循试验方法并跟踪研究。我们有完善的培训机制 为调查人员和工作人员提供便利，并确保没有利益冲突会影响试验结果。我们的核心提供 用于生物样本的采集、药代动力学分析和定量成像。我们通常会做整体 对晚期癌症患者的肿瘤进行外显子组和转录组分析，以寻找分子靶点 是我们护理标准和试验鉴定的一部分。对试验进行审计和跟踪，以确保应计 是稳健的并且正在遵循方法。我们有一个单独的研究药房来监督订购， 研究药物的储存、分配、运输和跟踪。我们所有的程序都是为了满足当地、 州和联邦法规，确保患者安全并收集经过验证的试验结果。