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

以I期为重点的新型抗癌药物的早期临床试验（U01）

基本信息

批准号：
7919074
负责人：
ROBERT S. DIPAOLA
金额：
$ 9.9万
依托单位：
UNIV OF MED/DENT NJ-R W JOHNSON MED SCH
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-08-01 至 2011-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7919074
关键词：
Adverse event Algorithms Antineoplastic Agents Biochemical Biological Markers Biometry Cancer Institute of New Jersey Cancer Therapy Evaluation Program Clinical Clinical Informatics Clinical Investigator Clinical Research Clinical Trials Clinical Trials Database Comprehensive Cancer Center DNA Development Documentation Dose Drug Delivery Systems Drug Kinetics Electronics Goals Grant Human Immunologics Institution Malignant Neoplasms Microtubules Monitor New Jersey Online Systems Patients Pharmacodynamics Pharmacy facility Phase Population Population Density Research Research Infrastructure Research Personnel Resource Sharing Resources Retrieval Schedule Services Signal Pathway System Time Tissues Training and Education United States Validation Visit electronic data sharing novel pilot trial research clinical testing response translational clinical trial

项目摘要

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.

描述（由申请人提供）：本申请的目标是利用 NCI 癌症治疗评估计划赞助的新型抗癌药物开发并进行早期临床试验。新型抗癌药物的发现和临床评价是新泽西州癌症研究所（CINJ）的最高战略目标之一，该研究所是新泽西州唯一的 NCI 指定的综合癌症中心。自成立以来，CINJ 一直专注于早期临床试验的开发，并注重转化。 CINJ 临床研究人员在转化临床试验开发方面拥有出色的记录，包括在 NCI 资助的多项 I 期/试点试验中进行药代动力学/生物标志物研究。该专业知识涵盖广泛的药物靶点，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 年到 2006 年，CINJ 开展了 42 项 I 期试验或试点试验，平均每年有 151 名患者参加这些试验。这些研究中的科学主题包括统计驱动的剂量和时间表查找算法，以及通过癌症组织的生化研究来验证目标调节。 CINJ 为新型抗癌药物的早期临床试验提供了特殊而独特的资源。新泽西州人口预计到2008年将达到900万，是美国人口密度最高的州，平均每平方英里有1,174人，是全国平均水平的13倍。 CINJ 主要设施每年接待大约 70,000 名患者，并且每年接待超过 6000 名新患者。全州范围内的附属机构网络有助于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，包括生物识别、临床研究人员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控试验开发、应计、不良事件和反应，以及与 NCI 试验监控系统共享电子数据。