Research On Risk Management And Control Of Clinical Trials Of Innovative Drugs Under The New Policy Environment

The clinical trial of innovative drugs has the characteristics of long cycle,large investment and high risk,which is the key link and "speed limiting step" of drugs to market successfully.It is of great significance to strengthen the research on risk management and control of clinical trials of innovative drugs and effectively control risks to promote the implementation of clinical trials and the listing of innovative drugs.Based on the study of the relevant policy documents of innovative drug clinical trials and the analysis of the development status of innovative drug clinical trials at home and abroad,this article studied and put forward the risk management and control measures of innovative drug clinical trials from four aspects of risk management plan,risk identification,risk assessment and risk management and control strategy by using the risk management theory,and proposed the corresponding guarantee mechanism,to provide reference for the management and control of innovative drug clinical trials.In order to comprehensively promote the development of innovative drugs in China,the state has issued a series of policy and legal documents related to clinical trials of innovative drugs since 2015.During this time,The clinical trial review and approval procedures have been gradually optimized,the management of clinical trial institutions has been gradually improved,and the management of clinical trial data has been gradually strengthened.China has formed an innovative drug research and development policy system oriented by "clinical value".Chinese innovative drug research and development is facing important development opportunities,and putting forward higher and stricter requirements for innovative drug clinical trials at the same time.By using the work breakdown structure method to sort out the main links of innovative drug clinical trials,learning relevant policies,legal documents and related literature,and combining expert opinions,this article summarized the risk factors of innovative drug clinical trials into 9 first-level indicators and 31 second-level indicators.Using questionnaire survey method to evaluate the occurrence probability and influence degree of 31 secondary index risk factors.On this basis,principal component analysis was used to quantitatively evaluate the risk of innovative drug clinical trials,and the 31 risk factors were comprehensively summarized as seven major risks including drug and biological sample management risk,trial plan design risk,clinical trial institution risk,safety report management risk,ethical review risk,policy and legal risk and subject management risk.The risks of innovative drug clinical trials exist in the whole process of clinical trials.It is necessary to focus on strengthening the risk management and control of key links to avoid or reduce the risks of clinical trials as much as possible.Combined with the risk identification and evaluation results of innovative drug clinical trials,actual clinical trials and expert opinions,the corresponding control strategies were proposed from nine aspects,including policy and law,clinical trial institution,trial scheme design,ethical review,subject management,experimental drugs,biological sample management,data management and safety report management.And it proposed to establish four major guarantee mechanisms,including risk management and control organization and coordination mechanism,risk management and control expert consultation mechanism,risk dynamic monitoring mechanism and risk management and control evaluation mechanism,to ensure that the management and control strategy is implemented in place.