新药研发外包中的合同研究组织(CRO)研究综述

A Review of Contract Research Organization (CRO) in New Drug Research and Development Outsourcing

摘要: 新药研发服务随着药物研发的转型和海外订单的转移，成为了我国科技创新的发展方向之一。合同研究组织(Contract Research Organization, CRO)作为新药研发服务的主体，也随之受到了广泛的关注。因此，本文基于服务外包的分析框架，分别从外包内容、外包动机、外包方法和外包结果对新药研发外包中CRO的相关研究进行了综述。首先，通过区分仿制药和创新药，讨论了新药研发的特点和背景。然后，从新药研发外包所涉及的具体任务和活动、采用CRO的优势、研发服务外包的模式和方法等方面对相关文献进行了综述。通过综合分析这些问题，指出目前新药研发外包中CRO研究的不足和空白，为相关研究的下一步工作提供参考。

Abstract: With the transformation of drug research and the shifting of overseas orders, new drug R&D ser-vices have become one of the directions for scientific and technological innovation in China. Contract Research Organization (CRO), as the main entities providing new drug R&D services, have also received extensive attention. Therefore, based on the analysis framework of service outsourcing, this article provides a review of relevant research on CRO in the new drug R&D outsourcing, focusing on outsourcing content, outsourcing motivation, outsourcing methods, and outsourcing outcomes. First, by distinguishing between generic drugs and innovative drugs, the characteristics and background of new drug R&D are discussed. Then, the specific tasks and activities involved in new drug R&D outsourcing, the advantages of adopting CRO, and the models and methods of R&D outsourcing are reviewed. By comprehensively analyzing these issues, the deficiencies and gaps in CRO research in the new drug R&D outsourcing are identified, providing references for future research in this field.