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欧洲癌症研究与治疗组织(EORTC)试验的科学综述:新治疗委员会和方案审查委员会的运作

Scientific review of EORTC trials: the functioning of the New Treatment Committee and Protocol Review Committee.

作者信息

Lardot C, Steward W, Van Glabbeke M, Armand J-P

机构信息

EORTC Data Center, Avenue E. Mounier 83, bte 11, B- 1200, Brussels, Belgium.

出版信息

Eur J Cancer. 2002 Mar;38 Suppl 4:S24-30. doi: 10.1016/s0959-8049(01)00453-1.

Abstract

New anticancer treatments (new therapeutic strategies or new compounds) require careful development in which cancer clinical trials are an essential element. Two scientific committees, namely the New Treatment Committee and the Protocol Review Committee, ensure the review of all EORTC protocols with respect to the interest and originality, methodology, feasibility and relevance within the EORTC framework. Both Committees are involved early in the evaluation of the new concept proposal and follow all aspects (methodology, administrative, regulatory) of the protocol development process. Throughout its 25 years of existence, the Protocol Review Committee has streamlined drug and protocol evaluations and has developed standard operating procedures to handle those reviews in a very efficient and fast manner. Since 1997, the New Treatment Committee has contributed to strengthening the EORTC during the development process with the aim of ensuring an optimal flow of information on new drugs between laboratory and clinical research divisions.

摘要

新的抗癌治疗方法(新的治疗策略或新化合物)需要经过精心研发,其中癌症临床试验是关键要素。两个科学委员会,即新治疗委员会和方案审查委员会,负责审查所有欧洲癌症研究与治疗组织(EORTC)的方案,评估其在EORTC框架内的趣味性与原创性、方法学、可行性及相关性。这两个委员会在新概念提案评估的早期阶段就参与其中,并跟踪方案开发过程的各个方面(方法学、行政、监管)。在其存在的25年里,方案审查委员会简化了药物和方案评估流程,并制定了标准操作程序,以便高效快速地处理这些审查。自1997年以来,新治疗委员会在开发过程中为加强EORTC做出了贡献,目的是确保新药信息在实验室和临床研究部门之间实现最佳流通。

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