Ansher S S, Scharf R
Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Rockville, Maryland 20852, USA.
Ann N Y Acad Sci. 2001 Dec;949:333-40. doi: 10.1111/j.1749-6632.2001.tb04041.x.
The mission of the Cancer Therapy Evaluation Program (CTEP), a clinical research program of the National Cancer Institute (NCI), is to reduce the burden of cancer. CTEP plans, reviews, and coordinates clinical trials for investigational anticancer agents, from the inception of protocols through the preparation and submission of Investigational New Drug Applications (INDs) to the Food and Drug Administration (FDA). CTEP also serves as a liaison to the FDA for the extramural clinical research community and industry collaborators. Other CTEP functions include managing, tracking, and reviewing clinical protocols as well as monitoring, planning, and maintaining regulatory compliance of the clinical trials. In addition, CTEP coordinates the distribution of the investigational agents from industry collaborators for use in all NCI-sponsored clinical trials. The advantages of collaborating with CTEP are described as well as details about the contractual framework, either a Clinical Trials Agreement (CTA) or a Cooperative Research and Development Agreement (CRADA), for such a collaboration. Many of the concerns raised by industry collaborators with respect to intellectual property, data access, and publications are also addressed.
癌症治疗评估项目（CTEP）是美国国立癌症研究所（NCI）的一个临床研究项目，其使命是减轻癌症负担。CTEP负责计划、审查和协调针对研究性抗癌药物的临床试验，从方案的制定到向美国食品药品监督管理局（FDA）准备和提交新药临床试验申请（IND）。CTEP还作为外部临床研究团体和行业合作伙伴与FDA之间的联络人。CTEP的其他职能包括管理、跟踪和审查临床方案，以及监督、规划和维持临床试验的法规合规性。此外，CTEP协调来自行业合作伙伴的研究性药物的分发，以供所有由NCI赞助的临床试验使用。文中描述了与CTEP合作的优势以及关于此类合作的合同框架细节，即临床试验协议（CTA）或合作研究与开发协议（CRADA）。文中还讨论了行业合作伙伴提出的许多与知识产权、数据访问和出版物相关的问题。
