Objective:Based on the analysis of the time consumption in each link of the ethical review on clinical trials,the strategies to further improve the efficiency of review are discussed.Methods:The medical research ethics committee of a grade-A third-level Hospital accepted 278 initial review trials and 522 amendment review trails in 2023,the time consumption,including waiting time,review time and approval time of different review types and different review methods,of different link in review progression were analyzed.Results:The average time of waiting consumption and approval consumption for initial review on drug or medical device clinical trials took 12 and 22days,and it for the initial review on the clinical trials of in vitro diagnostic reagents were 3 and 9.5 days.When expedited review was adopted for amendments,the average time of waiting consumption and approval consumption were 6 and 11 days,while,it for full board review on amendments were 13 and 15.5 days,respectively.Conclusion:EC should strengthen the formal review to improve the one-time approval rate of the full board review,Optimize the ethical management and review process to improve the efficiency of the expedited review,and strengthen communication between sponsors,researchers and EC offices to improve the efficiency of ethical review.
ethical reviewclinical trailsethics committeeefficiency of ethical review
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