Research On Risk Management Of The New Drug Enalapril Folic Acid Tablets Postmarketing Clinical Trial Project

New drug research and development is a high technological content,large investment and highly competitive activity.It has a wide range of links,long development cycle,and low success rate and so on,which determine the characteristics of high risk.How to effectively avoid the high risk is an urgent and arduous task for Chinese medical science and technology workers.Therefore,it is of great significance for the development of China’s pharmaceutical industry to analyze the risk factors existing in the new drug research and development activities and carry out effective risk management.At present,our understanding of risk in new drug research and development project is not enough.Although the awareness of risk management has been enhanced,there has not been a systematic operation guideline for it.The risk of new drug research projects in China is mostly in the non pharmaceutical industry,especially for the risk management of new drug clinical research,which is mostly limited to pre-marketing research.Few people have studied the risk management of new drug postmarketing clinical research from a clinical point of view.This article is trying to study in this field systematically.I had the honor to intervene in the new drug Enalapril Folic Acid Tablets postmarketing clinical trial project.Used with the project risk management knowledge and actual experience,I focused on the related risks of the new drug enalapril Folic Acid Tablets postmarketing clinical research project,to minimize the impact of risk on projects.Firstly,this paper described the background,purpose,current situation,content and method,and its significance of the study.Secondly,introduced the differences and connections between new drug research and development projects and new drug clinical research projects,including the general situation of the CER project and the risk management planning based on WBS.Thirdly,this paper researched on risk identification,risk assessment and risk countermeasures for CER projects respectively.Finally,we drew the conclusion of risk management research for new drug postmarketing clinical research.In the risk identification,we used the checklist,graphic technique and brainstorming method to collect the risk factors widely,the main risk is determined by interview survey and the Pareto’s law.In the risk assessment,we used AHP evaluation model to evaluate the weight and control scheme of CER project risk factors.In the risk countermeasures,we used based on integrated strategies such as control models,monitoring and tracking,and dynamic management.The main risk management measures for CER project: Taking "human" as the main controlling factor,and gave different degrees of attention and priority control measures to "man-material-money" under different risks.Because all kinds of risks exist in new drug postmarketing clinical research projects,we need to carry out dynamic risk management in the whole process of new drug postmarketing clinical research projects.Through a series of studies in this article,the risk management model and management system of new drug clinical research based on CER project have been formed,this will provide some reference value and guiding significance for risk management of other new drugs in postmarketing clinical research.