Management And Control Of Risk On Preclinical Stage Of New Drug

High risk,high cost,and long cycle characterized new drug research and development(R&D),especially,the preclinical stage,as a key before clinical study,crucial for new drugs to market successfully.The risk management of new drugs R&D projects should be micro-managed and detailed to each research stage.It is a continuous assessment process that can be divided into five steps: risk management planning,risk identification,risk assessment,risk response and risk control.Based on the analysis of characteristics of the new drug R&D projects,the characteristics of risk in new drug R&D project was analyzed,the content of risk management planning was described again,how to use the evidence-based method(EBM)to identify risk in preclinical stage was explored.With the method of qualitative and quantitative analysis method,we conducted a questionnaire survey in the form of E-mail and a risk assessment,and we put forward to the corresponding countermeasures for different risk factors,and we designed the risk monitoring table to monitor the risk in preclinical study stage,and establishfor an effective risk management model for preclinical study stage.This article set reversible AChE that can treat Alzheimer’s disease as an example to conduct a comparative study of published animal studies between new drugs failed in clinical trials(Zanapezil and Phenserine)and new drugs successfully served for patient(Donepezil,Rivastigmine and Galantamine)using evidence-based method.The goal is to illustrate how to use evidence-based method to identity risk.Combined with Work Breakdown Structure method(WBS),the identified risks in preclinical study stage was classifiecd as decision-making risk,financial risk,management risk,environment risk,technology risk,security risk.According to qualitative assessment of identified risks,it is found that the risk of incomplete design is very high in the preclinical study stage.The risk of technical difficulty and complexity,the risk of technical knowledge cannot be obtained,the risk of technology immaturity,decision-making risk and management risk play a decisive role in the success of R&D.To improve the accuracy of the analysis,we used principal component analysismethod and got a result that technical risks,policy risks,experimental environment risk and decision-making risk is priority for R&D institutions to manage risk in preclinical study stage.Thus,this research made the risk-coping strategies from six aspects of decision-making,capital,management,environment,technology and safety,and designed the risk monitoring table,and established the risk management process.This study shows that risk can be more specific and more operable through micro-management and the EBM in the application of risk identification has an important value to risk management,reasonable risk management planning and adequate risk identification help to develop effective risk-coping strategies and monitoring measures.It can stop the risk from start and reduce the failure rate of clinical study for new drugs.