中国药物评价
中國藥物評價
중국약물평개
Chinese Journal of Drug Evaluation
2015年
4期
233-236
,共4页
冯鑫媛%孙烜%安娴%田金徽
馮鑫媛%孫烜%安嫻%田金徽
풍흠원%손훤%안한%전금휘
儿童%临床试验%现状分析
兒童%臨床試驗%現狀分析
인동%림상시험%현상분석
Children%Clinical Trial%Current situation
目的:检索并调查中国临床试验注册中心的儿童临床试验现状。方法:计算机检索中国临床试验注册中心中以儿童为研究对象的临床试验,检索时间截至2014年4月。两名研究者独立筛选检索到的临床试验,并按预先设计的资料提取表提取疾病类型、资助基金和注册时间等内容,并将数据输入Excel ,使用SPSS 17.0软件进行统计分析。结果:检索获得儿童临床试验共计133项,儿童临床试验注册数量随时间推移而不断增加;申请人所在单位为医院的有72项(54.1%);93项(69.9%)临床试验的注册号状态是预注册,85.7%的临床试验获得伦理委员会的批准;政府经费资助的试验项目最多,占29.6%;干预措施类型中,药物干预最多,有62项(46.6%),干预性研究有78项(58.6%),随机平行对照试验占64.7%,仅24.8%的临床试验说明使用了盲法。试验资料收集、分析、管理单位为医院的试验项目数分别为47项(35.1%),45项(33.8%),33项(24.6%)。结论:儿童临床数量在不断增加,且大部分儿童临床试验受政府资助,这将有助于减少部分偏倚,今后研究应更多关注注册的临床试验的注册质量问题,借以推动儿童临床试验的发展。
目的:檢索併調查中國臨床試驗註冊中心的兒童臨床試驗現狀。方法:計算機檢索中國臨床試驗註冊中心中以兒童為研究對象的臨床試驗,檢索時間截至2014年4月。兩名研究者獨立篩選檢索到的臨床試驗,併按預先設計的資料提取錶提取疾病類型、資助基金和註冊時間等內容,併將數據輸入Excel ,使用SPSS 17.0軟件進行統計分析。結果:檢索穫得兒童臨床試驗共計133項,兒童臨床試驗註冊數量隨時間推移而不斷增加;申請人所在單位為醫院的有72項(54.1%);93項(69.9%)臨床試驗的註冊號狀態是預註冊,85.7%的臨床試驗穫得倫理委員會的批準;政府經費資助的試驗項目最多,佔29.6%;榦預措施類型中,藥物榦預最多,有62項(46.6%),榦預性研究有78項(58.6%),隨機平行對照試驗佔64.7%,僅24.8%的臨床試驗說明使用瞭盲法。試驗資料收集、分析、管理單位為醫院的試驗項目數分彆為47項(35.1%),45項(33.8%),33項(24.6%)。結論:兒童臨床數量在不斷增加,且大部分兒童臨床試驗受政府資助,這將有助于減少部分偏倚,今後研究應更多關註註冊的臨床試驗的註冊質量問題,藉以推動兒童臨床試驗的髮展。
목적:검색병조사중국림상시험주책중심적인동림상시험현상。방법:계산궤검색중국림상시험주책중심중이인동위연구대상적림상시험,검색시간절지2014년4월。량명연구자독립사선검색도적림상시험,병안예선설계적자료제취표제취질병류형、자조기금화주책시간등내용,병장수거수입Excel ,사용SPSS 17.0연건진행통계분석。결과:검색획득인동림상시험공계133항,인동림상시험주책수량수시간추이이불단증가;신청인소재단위위의원적유72항(54.1%);93항(69.9%)림상시험적주책호상태시예주책,85.7%적림상시험획득윤리위원회적비준;정부경비자조적시험항목최다,점29.6%;간예조시류형중,약물간예최다,유62항(46.6%),간예성연구유78항(58.6%),수궤평행대조시험점64.7%,부24.8%적림상시험설명사용료맹법。시험자료수집、분석、관리단위위의원적시험항목수분별위47항(35.1%),45항(33.8%),33항(24.6%)。결론:인동림상수량재불단증가,차대부분인동림상시험수정부자조,저장유조우감소부분편의,금후연구응경다관주주책적림상시험적주책질량문제,차이추동인동림상시험적발전。
Objective:To identify clinical trials in children and survey of their characteristics in Chinese Clinical Trial Registry ( Chi-CRT).Methods:All records within the ChiCRT were scanned for clinical trials in children .Two reviewers screened the retrieved records for potentially relevant papers and extracted details on type of disease , clinical study categories ,fund and registration year .Results:133 were included ,the frequency of clinical trials in children were found to increase over time The number of clinical trials in children in Chi -na is increasing, applicant′s institution of 72(54.1%)clinical trials were hospital, registration status of 93(69.9%)clinical trials were prospective registration , 85.7%clinical trials were approved by ethic committee ,29.6%clinical trials were supported by public fund ,62 (46.6%)clinical trials focused on the drug, study type of 78(58.6 %)clinical trials were interventional study,64.7% clinical trials were randomized controlled trials ,only 24.8% clinical trials used blinding .Data collection institution of 47 ( 35.1%) clinical trials were hospital,data analysis institution of 45(33.8%)clinical trials were hospital,data management institution of 33(24.6%)clinical trials were hospital.Conclusion:This investigation shows the number of clinical trials was increased ,majority of clinical trials were supported by public organization,which may be reduce the other bias.Therefore,we suggest that future research on assessment of registration quality of trials in children.