Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis (U01)

描述（由申请人提供）：本申请的目标是开发和执行由NCI癌症治疗评估计划赞助的新抗癌药物的早期临床试验。新抗癌剂的发现和临床评价是新泽西癌症研究所（CINJ）的最高战略目标之一，CINJ是新泽西唯一一家由NCI指定的综合性癌症中心。从一开始，CINJ就专注于早期临床试验的开发，重点是转化。CINJ临床研究人员在转化临床试验开发方面有着出色的记录，包括由NCI赠款的几项I期/试点试验中的药代动力学/生物标志物研究。该专业知识涵盖了广泛的药物靶点，包括细胞信号传导途径以及新型免疫学、DNA和微管相关靶点。从2004年至2006年，CINJ进行了42项I期或试点试验，这些试验平均每年增加151例患者。这些研究中的科学主题包括统计驱动的剂量和时间表发现算法，以及通过癌症组织的生化研究验证靶点调节。CINJ为新抗癌药物的早期临床试验提供了特殊和独特的资源。预计到2008年人口将达到9，000，000，新泽西是美国人口密度最高的地区，平均每平方英里1，174人，是全国平均水平的13倍。CINJ主要设施每年约有70，000名患者就诊，每年有6000多名新患者就诊。全州范围内的附属机构网络促进了早期临床试验的转诊。CINJ拥有由多个共享资源提供的出色的临床研究基础设施，包括生物统计学，临床研究人员的集中教育和培训服务，人类研究服务办公室，药代动力学/药效学，研究药房和组织检索服务。临床信息学资源包括电子订单输入、电子临床文档和基于网络的临床试验数据库，该数据库允许在线监测试验开发、应计、不良事件和响应，以及与NCI试验监测系统共享电子数据。

DESCRIPTION (provided by applicant): The goal of this application is to develop and perform early clinical trials with new anti-cancer agents sponsored by the NCI Cancer Therapy Evaluation Program. Discovery and clinical evaluation of new anti- cancer agents is one of the highest strategic objectives of the Cancer Institute of New Jersey (CINJ), the only NCI-designated comprehensive cancer center in New Jersey. From its inception, CINJ has focused on development of early clinical trials with a translational emphasis. CINJ clinical investigators have an outstanding record of translational clinical trial development, including pharmacokinetic/biomarker studies in several phase I/pilot trials supported by grants from the NCI. This expertise encompasses a wide range of drug targets, including cellular signaling pathways as well as novel immunologic, DNA-, and microtubule- associated targets. From 2004-2006, 42 phase I or pilot trials were active at CINJ, with an average annual accrual of 151 patients to these trials. Scientific themes within these studies included statistically driven dose- and schedule-finding algorithms, as well as validation of target modulation by biochemical studies of cancer tissues. CINJ provides an exceptional and unique resource for early clinical trials of new anti-cancer agents. Expected to reach a population of 9,000,000 by 2008, New Jersey has the highest population density in the United States, with an average of 1,174 people per square mile, which is 13 times the national average. Approximately 70,000 patient visits occur yearly at the main CINJ facility, and over 6000 new patients are seen each year. A statewide network of affiliated institutions facilitates referral for early clinical trials. CINJ has an outstanding clinical research infrastructure provided by several Shared Resources, including Biometrics, Centralized Education and Training Services for Clinical Research Personnel, Office of Human Research Services, Pharmacokinetics/Pharmacodynamics, Research Pharmacy, and Tissue Retrieval Services. Clinical informatics resources include electronic order entry, electronic clinical documentation, and a web-based clinical trials database that allows online monitoring of trial development, accrual, adverse events, and responses, as well as electronic data sharing with NCI trial monitoring systems.