摘要
目的了解申办方为我院药物临床试验购买保险现状，进而了解我国通过购买保险降低药物临床试验风险情况。方法通过我院自主研发的“药物临床试验信息管理系统”下载2009年】月至2012年12月已通过医学伦理委员会审批通过的药物临床试验备案资料工作表251份及相对应的临床试验备案资料，从而转换统计对临床试验投保率随年代变化趋势、国内外申办方为I～Ⅳ期临床试验投保情况、国内外申办方投保与实施概况进行描述性分析。结果2009年至2012年，国外申办方为临床试验年度投保率显著高于国内申办方。结论国内外申办方为药物临床试验投保情况与国家相应法规政策、人们对药物临床试验风险认知相关。应提高对药物临床试验风险认识，完善建立药物临床试验风险社会保障体系和保险制度，使我国药物临床试验能最大程度降低风险并且快速发展。
AIM To investigate the status of insurance purchased by sponsor for drug clinical trials in our hospital and analyze the possible situation through the purchase of insurance to reduce the risk of drug clinical trials in our country. METHODS The 251 drug clinical trial information on record, which approved by Independent Ethics Committee from January 2009 to December 2012, was collected though the drug clinical trials information management system as excel record worksheets. With some conversion and statistiction, the data were descriped and analyzed as the clinical trials insurance rate trend by years, the status of phase I - IV clinical trials insured by internal and external sponsors, the overview of internal and external sponsors insure and implementation. RESULTS The clinical trials annual insurance rate of external sponsors were significantly higher than internal sponsors＇ from 2009 to 2012. CONCLUSION The status of insurance purchased by sponsor for drug clinical trials was related to the corresponding national regulations and policies, so as the cognitive people on the risk of drug clinical trials. Not only the understanding of the risk on drug clinical trial should be improved but also the social security system and the insurance system on risk of drug clinical trials well- established. It is the way may minimise risk and develop rapidily of our drug clinical trials.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2013年第12期946-949,共4页
Chinese Journal of New Drugs and Clinical Remedies
基金
国家科技重大专项子课题项目(2012ZX09303004-002)
关键词
药物临床试验
保险
降低风险行为
社会保障
drug clinical trials
insurance
risk reduction behavior
social security
