新药研发课题任务及结题验收中关键问题的思考

Consideration on the key issues in tasks and acceptance of the new drug research and development project

课题任务书是科研项目承担单位向上级主管部门申报立项的重要文件,也是撰写经费预算书和结题验收的重要依据。本文结合近年来新药创制重大专项中新药研发的课题任务书撰写及在结题验收中发现的一些关键问题实例,提出了相关意见和建议,以期为课题负责人及承担单位提供参考,最大可能地降低新药研发的风险和成本,确保药物研发的顺利进行。

Task is an important document for scientific research project undertakers to declare projects to higher authorities,and it is also an important basis for compiling budget and final subject acceptance check.In this paper,based on the key problems found on the writing of the task assignment and the final examination and acceptance of the new drug research and development(R&D)in recent years,some suggestions are put forward in order to provide advice for the subject leaders and undertakers,reduce the risk and cost of the new drug R&D projects,provide reference for the project leaders and undertakers,and to ensure the successful progress of R&D projects.