Analysis on the adverse events and risk management in phase Ⅰ clinical trials

LI Yan-fen; HUANG Xing; WANG Rui-hua; MI Bo; HUANG Yu-hong

Abstract：Objective:Through collecting the phase Ⅰ clinical laboratory test project completed in our center in recent years,the adverse reactions/events in the project summary/report were summarized.The adverse events rate and related factors in clinical trials of drugs were also analyzed,which will help to improve the safety of clinical trials and supervision.Methods:Analysis of the dataof the 24 new drugs completed phase Ⅰ clinical trials in the centerresearch in recent years.Based on the analysis of the causes of adverse events in clinical trials and explore phase Ⅰ clinical trial's risk management.Results:Among the 590 subjects,39 had adverse events,so the incidence rate of adverse events was 6.61％.For the 2 drugs of tolerance test,6 cases of adverse events occurred in the total of 62 cases,with the incidence rate of adverse events 9.68％;For the 16 drugs with pharmacokinetics test,21 eases of adverse events occurred inthe total of 352 cases,with the incidence rate of adverse events 5.97％;For the 6drugs with bioequivalence trials,12 cases adverse events occurred in the total of 176 cases,with the incidence rate of adverse events 6.82％.Conclusion:In different stages of phase Ⅰ clinical trials,specific measures should be taken to reduce the incidence of adverse events,risk management should be strengthen to protect the safety of subjects and to ensure the confirmatory trials conclusions,so as to improve the quality of clinical trials.