UM1 Supplement for Early Therapeutic Trials with Phase 2 Intent

 描述(由申请人提供)：本提案的总体目标是向OSU UM1(P.I.Michael Grever)提供资源，用于进行国家癌症研究所(NCI)赞助的药物的第二阶段临床试验，评估这些药物对其分子靶标的生物效应，评估其他相关的生物效应，并确定临床相关结果/疗效和毒性的相关性。俄亥俄州立大学NCI指定的综合癌症中心(OSUCCC)及其附属医院和诊所每年产生超过5600名新的分析癌症患者。在这项补充提案中，OSUCCC与俄亥俄州的其他大型癌症研究和治疗中心合作：大学医院塞德曼癌症中心、克利夫兰诊所陶西格癌症研究所、凯斯西储大学NCI指定的病例综合癌症中心的联盟成员(每年另外10,000名分析性新癌症患者)以及NCI新指定的肯塔基大学Markey癌症中心(MCC)。有了地理位置接近的后者，我们现在可以为患者提供在连续地区(俄亥俄州-肯塔基州-西弗吉尼亚州走廊)进行第二阶段试验的机会，并获得新的治疗方法。重要的是，它将严重缺乏服务的特殊人群(来自阿巴拉契亚中部地区的患者)纳入新靶点的生物和治疗评估。进入英国排名最高的药学学院，现在进一步加强了我们的翻译科学专业知识。

 DESCRIPTION (provided by applicant): The overall goal of this proposal is to provide a resource to the OSU UM1 (P.I. Michael Grever) for the conduct of Phase 2 clinical trials of National Cancer Institute (NCI) sponsored agents, to evaluate biologic effects of these agents on their molecular targets, to evaluate other relevant biologic effects, and to determine clinical relevant outcomes/correlates of efficacy and toxicity. The Ohio State University NCI-designated Comprehensive Cancer Center (OSUCCC) and its affiliated hospitals and clinics generate a resource of more than 5600 new analytic cancer patients per year. For this supplement proposal, the OSUCCC is partnering with other large cancer research and treatment centers in the State of Ohio: Seidman Cancer Center of University Hospitals Case Medical Center and The Cleveland Clinic Taussig Cancer Institute, consortium members of the NCI-designated Case Comprehensive Cancer Center at Case Western Reserve University (another 10,000 analytic new cancer patients per year) and the newly NCI-designated Markey Cancer Center (MCC) at the University of Kentucky (UK). With the latter institution that provides geographical proximity, we can now provide patients the opportunity for Phase 2 trials in a contiguous region (Ohio-Kentucky-West Virginia corridor) with access to novel therapeutics. It importantly incorporates a heavily underserved and special population (patients from the Central Appalachian Region) to the biological and therapeutic evaluation of novel targets. Access to a top rated school of pharmacy at UK, now strengthens further our translational science expertise.