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

卡马诺斯癌症研究所(KCI)是NCI指定的综合性癌症研究所，致力于促进临床 试验的开发和实施。以这个身份，我们通过国家临床试验参与了许多试验 网络(NCTN)和领先的学术参与网站(LAPS)。我们进行早期临床试验的努力的一部分 审判涉及我们参加2020年的Catch-Up。KCI于2020年8月加入追赶NCI计划。 通过这一机制进行的第一次试验于2020年9月底开始。我们有19个试验是在 追赶和11家公司仍可进行应计利润。在第一次试验开始的13年里，我们已经招募了24人 病人。因此，我们应该能够很容易地每年招募至少5名有EDDOP支持的患者。我们现在 有大约189项干预试验可以积累，并已制定了所有必要的程序，以确保 保护受试者，遵循试验方法，跟踪研究。我们有适当的培训机制 为调查人员和工作人员提供便利，并确保不会有利益冲突影响审判结果。我们的核心提供 用于生物有机磷农药的采集、药代动力学分析和定量成像。我们例行公事地 晚期癌症患者肿瘤外显子组和转录组分析寻找分子靶点 是我们护理和试验鉴定标准的一部分。对试验进行审计和跟踪，以确保应计 是稳健的，方法是被遵循的。我们有一个单独的研究药房来监督订购， 研究试剂的储存、分配、运输和跟踪。我们所有的程序都是为了满足当地人， 州和联邦法规，并确保患者安全和收集经过验证的试验结果。

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.