Analysis Of Reasons For Suspension Or Termination Of Drug Clinical Trials

Objective:To collect the clinical trial databases at home and abroad and the clinical trials suspended or terminated by ten medical institutions in Guangdong Province,classify and summarize the statistics according to the year,indication,stage and drug type,compare the reasons for the suspension and termination of clinical trials at home and abroad,compare the reasons for the suspension or termination between medical institutions and databases,and analyze the impact of different reasons on the implementation process of clinical trials,Provide corresponding suggestions to shorten the progress of clinical trials,reduce the suspension or termination rate of clinical trials,and improve the efficiency of clinical trials.Method:1.Search the literature,laws and regulations related to the suspension or termination of clinical trials at home and abroad,understand the difficulties that may be encountered in the implementation of clinical trials,and understand the current legislative status of the suspension or termination of clinical trials.2.Collect the reasons for the suspended or terminated clinical trials at home and abroad,carry out primary and secondary classification,and compare the suspended trials,terminated trials,the reasons for the suspended or terminated trials at home and abroad,as well as the differences in general information such as indications,year,trial stage and drug type at home and abroad.3.Analyze the reasons for suspension or termination of domestic and foreign trials with different indications,different stages and different trial years,and the correlation between different reasons.Result:According to the collected data of clinical trials suspended or terminated at home and abroad,that is,as of December 31,2021,119664 clinical trials have been carried out at home and abroad,of which 8470 have been suspended or terminated.According to the data at home and abroad,the proportion of suspension or termination of drug clinical trials was 7.08%(8470 /119664).The proportion of suspension or termination of drug clinical trials accounted for 4.0%(624 / 15522)of the total domestic clinical trials,including 122 projects in medical institutions and 502 projects on the publicity platform.Clinical Trials.Gov screening time is from January 1,2017 to December 31,2021.The intervention measure is "drug".A total of 7846 clinical trials were suspended or terminated,accounting for 7.53%(7846 / 104142)of foreign clinical trials.The reasons for the suspension or termination of clinical trials at home and abroad are the sponsor(strategy,capital and business,etc.),the test results,the progress of subjects’ enrollment,safety considerations,scheme design adjustment,trial drugs,relevant clinical research units,epidemic impact and other aspects.The main reasons for the suspension or termination of medical institutions are the sponsor’s strategy,business and capital,followed by the progress problems related to clinical research centers.The progress problems such as enrollment are the third largest reason,in which chemical drugs and biological products account for the majority,and phase Ⅲ clinical trials account for the most.The main reason for the suspension or termination of domestic publicity platforms is the sponsor’s strategy,business and capital,and the secondary reason is that the test results are related,in which chemical drugs account for the highest proportion and the suspension or termination rate of be clinical trials is the highest.In the clinical trials suspended or terminated abroad,the main reasons are the progress problems such as the enrollment of subjects,and the secondary reasons are the results of clinical trials,the sponsor’s strategy,business and capital.Among them,the classification of drug clinical trials accounts for the highest proportion,and the suspension or termination of phase Ⅱ clinical trials accounts for a higher proportion.The reasons for the suspension or termination of foreign phase Ⅰ trials are different in different stages.The reasons for the suspension or termination of foreign phase Ⅱ-Ⅳ trials are the strategy,business and capital of the sponsor,and the main reasons for the suspension or termination of foreign phase Ⅱ-Ⅳ trials are the enrollment progress of subjects.The suspension or termination rate of domestic trials in recent three years has decreased year by year,and the suspension or termination rate of foreign trials in recent four years has increased year by year.The three main indications for suspension or termination are tumor test,cardiovascular and hematological diseases and nervous system diseases.The main reasons for domestic trials are the sponsor’s strategy,business,capital and the correlation of test results.The main reasons for foreign trials are the integration progress of subjects and the correlation of test results.There were significant differences in the items suspended or terminated at home and abroad(p<0.05),in the items suspended or terminated at home and abroad in different years,stages and indications(p<0.05),and in the clinical trial items suspended or terminated by different drug types at home(p<0.05).Conclusion:By analyzing the reasons for suspension or termination in the implementation of drug clinical trials at home and abroad,it can be seen that the progress of subjects’ enrollment accounts for the main factor,and the second major factor is related to the test results.The reasons for suspension or termination also include the sponsor(strategy,capital,business,etc.),safety considerations,scheme design adjustment,trial drugs,clinical research center,epidemic impact,etc,The following aspects should be paid attention to during the implementation of drug clinical trials:(1)formulate a perfect subject inclusion strategy.(2)The sponsor shall make correct and reasonable decisions.(3)The experimental design is scientific and feasible.(4)Focus on the effectiveness and safety indicators of the test.(5)Strengthen the management of experimental drugs.(6)Improve the personnel,facilities and equipment of clinical research units.(7)Formulate risk response measures for public health emergencies.(8)Ensure the integrity of test data and strengthen communication with regulatory authorities.Strengthen the management of each stage of clinical trial,ensure the quality of clinical research,reduce the incidence of trial suspension or termination,and improve the efficiency of clinical trial.