中华医学科研管理杂志
中華醫學科研管理雜誌
중화의학과연관리잡지
ZHONGHUA YIXUE KEYAN GUANLI ZAZHI CHINESE JOURNAL OF MEDICAL SCIENCE RESEARCH MANAGEMENT
2011年
2期
80-83
,共4页
医学伦理%药物试验%临床研究%医院伦理委
醫學倫理%藥物試驗%臨床研究%醫院倫理委
의학윤리%약물시험%림상연구%의원윤리위
Medical Ethics%Drug trial%Clinical trials%Ethics Committees in hospital
目的通过对某医院伦理委员会近3年206项临床研究伦理审查情况分析,了解医院伦理审查的一般通过率和常见问题.方法查阅伦理会纪录,归类整理并使用ridit的CMH方法和Bootstrap方法统计分析.结果药物试验通过率为36.09%,器械为1 8.42%,课题为14.29%.在伦理审查发现的问题方面,知情同意占63.59%,方案占14.56%,CRF占7.77%,其他占22.82%;国内申办者的问题明显多于国外申办者.药物伦理审查通过率逐年降低,分别是2006年45.83%、2007年38.78%、2008年19.44%,2008年与2006年相比有统计学上的差异,P=0.029.在药物临床试验中修订项目审查国外明显高于国内,P=0.028.结论医院伦理会对临床研究伦理审查十分必要,审查中尤其要关注知情同意书和研究方案等.
目的通過對某醫院倫理委員會近3年206項臨床研究倫理審查情況分析,瞭解醫院倫理審查的一般通過率和常見問題.方法查閱倫理會紀錄,歸類整理併使用ridit的CMH方法和Bootstrap方法統計分析.結果藥物試驗通過率為36.09%,器械為1 8.42%,課題為14.29%.在倫理審查髮現的問題方麵,知情同意佔63.59%,方案佔14.56%,CRF佔7.77%,其他佔22.82%;國內申辦者的問題明顯多于國外申辦者.藥物倫理審查通過率逐年降低,分彆是2006年45.83%、2007年38.78%、2008年19.44%,2008年與2006年相比有統計學上的差異,P=0.029.在藥物臨床試驗中脩訂項目審查國外明顯高于國內,P=0.028.結論醫院倫理會對臨床研究倫理審查十分必要,審查中尤其要關註知情同意書和研究方案等.
목적통과대모의원윤리위원회근3년206항림상연구윤리심사정황분석,료해의원윤리심사적일반통과솔화상견문제.방법사열윤리회기록,귀류정리병사용ridit적CMH방법화Bootstrap방법통계분석.결과약물시험통과솔위36.09%,기계위1 8.42%,과제위14.29%.재윤리심사발현적문제방면,지정동의점63.59%,방안점14.56%,CRF점7.77%,기타점22.82%;국내신판자적문제명현다우국외신판자.약물윤리심사통과솔축년강저,분별시2006년45.83%、2007년38.78%、2008년19.44%,2008년여2006년상비유통계학상적차이,P=0.029.재약물림상시험중수정항목심사국외명현고우국내,P=0.028.결론의원윤리회대림상연구윤리심사십분필요,심사중우기요관주지정동의서화연구방안등.
Objective To reveal the average pass rate of a general hospital's ethic review and common problems.Methods The records generated by the ethics committee of a hospital in 3 consecutive years were reviewed and analysed with ridit of CMH and Bootstrap statistical methods.Results The pass rate for drug clinical trial is 36.09%,medical instruments 18.42%,and subject evaluation 14.29%.Among the problems,those concerning informed consent take up 63.59%,of protocol 14.56%,of CRF 7.77% and of the others 22.820%.The domestic applicants had more problems than those abroad.Besides,the pass rate of drug trials decreased with year from 45.83% in 2006 to 19.44% in 2008,which was statistically significant (P=0.029).In terms of drug clinical trial,the pass rate of revised projects in foreign countries was significantly higher than the domestic ones (P=0.028).Conclusion Ethics Committee in a hospital plays a very important role in clinical researches.And informed consent and research protocol are very important in the ethic review.
