Preclinical Efficacy and Intermediate Endpoints Assays

临床前疗效和中间终点检测

• 批准号: 7693573
• 金额: $ 148.78万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7693573
• 关键词: Preclinical; Efficacy; Intermediate; Endpoints; Assays

NCI is using a stepwise approach to assess the potential of various agents to inhibit, reverse and/or delay the carcinogenic process in various organs. One of the preclinical evaluations of potential chemopreventive agents is the demonstration of agent efficacy in preventing cancer in laboratory animal models. Both carcinogen-induced and transgenic animals are used for this purpose. Another area of preclinical development in chemopreventive agents is the development of surrogate intermediate endpoint biomarkers. Such biomarkers must be translatable to the clinic trial situation in order to shorten the time required to evaluate agents clinically in Phase II trials.

NCI正在使用逐步方法来评估各种代理抑制，逆转和/或延迟各种器官中的致癌过程的潜力。潜在化学预防剂的临床前评估之一是证明了在实验动物模型中预防癌症的药物功效。致癌物诱导的动物和转基因动物均用于此目的。化学预防剂中临床前开发的另一个领域是替代中间端点生物标志物的发展。这样的生物标志物必须可以翻译成临床试验状况，以缩短在II期试验中临床评估药物所需的时间。