Drug Development Support for the Cancer Therapy Evaluation Program (CTEP)

癌症治疗评估计划 (CTEP) 的药物开发支持

• 批准号: 7691876
• 金额: $ 460万
• 依托单位: TECHNICAL RESOURCES INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7691876
• 关键词: Drug; Development; Support; Cancer; Therapy

In order to assure that the Cancer Therapy Evaluation Program (CTEP) is able to fulfill its responsibilities as an IND sponsor, the CTEP Drug Development Support Contract for investigational anti-cancer agents provides the CTEP Investigational Drug Branch (IDB) and the Regulatory Affairs Branch (RAB) with assistance in a number of areas related to these responsibilities. These include 1) assistance in drafting and organizing Investigational New Drug Applications (INDs); 2) making copies of all IND submissions and delivering them to the FDA, as well as collaborators 3) maintaining databases for ND amendment submissions, protocols, FDA communications tracking, Cooperative Research and Development Agreements (CRADAs) and Clinical Trials Agreements (CTAs) as well as IND status; 4) receiving, processing, and performing an initial assessment of AEs, requesting appropriate supplemental data if required and preparing written adverse event reports for submission to the FDA, with copies to pharmaceutical collaborators.

为了确保癌症治疗评价项目（CTEP）能够履行其作为IND申办者的职责，CTEP研究性抗癌药物药物开发支持合同为CTEP研究药物分支（IDB）和法规事务分支（RAB）提供了与这些职责相关的多个领域的协助。这些包括：1）协助起草和组织研究性新药申请（IND）; 2）复制所有IND提交资料并将其提交给FDA以及合作者; 3）维护ND修正案提交资料、方案、FDA通信跟踪、合作研发协议（CRADA）和临床试验协议（CTA）以及IND状态的数据库; 4）接收、处理和进行AE的初步评估，如果需要，要求适当的补充数据，并准备书面不良事件报告提交给FDA，并将副本提交给制药合作者。