研究者发起的临床研究项目实施过程质量评估指标构建探讨
|
摘要
研究者发起的临床研究(IIT)既不同于药物注册为目的的新药临床试验,又不同于基础科学研究,需要独特的研究过程质量评估指标。本研究通过对国内外相关法规及文献的系统分析、专家咨询等方式确定了质量评估指标体系,包括执行进度、执行质量、伦理合规、科学性等4个一级指标(简称P*Q*R*S)。并采用相关性分析和验证性二阶因子模型对该体系进行了理论验证,并通过临床研究实例分析进行了可行性验证。本研究构建的P*Q*R*S体系合理、实用,可为IIT项目临床研究组修正项目执行过程中出现的问题及相关部门项目管理提供参考。
Investigator-initiated trial(IIT) is different from industry-sponsored trial and basic scientific research,which requires unique implementation process quality assessment indexes.Through systematic analysis of relevant laws and documents at home and abroad,expert consultation and other ways to determine the index system of quality assessment,including four first-level indicators:progress,quality,regulation,and science(P*Q*R*S).The theory is based on correlation analysist and the statistical method of second-order latent variable model.The feasibility study was carried out through clinical research examples.The P*Q*R*S constructed in this study is reasonable and practical,and can correct problems in the implementation process of the project and provide decision-making basis for the project management of relevant departments.
Investigator-initiated trial(IIT) is different from industry-sponsored trial and basic scientific research,which requires unique implementation process quality assessment indexes.Through systematic analysis of relevant laws and documents at home and abroad,expert consultation and other ways to determine the index system of quality assessment,including four first-level indicators:progress,quality,regulation,and science(P*Q*R*S).The theory is based on correlation analysist and the statistical method of second-order latent variable model.The feasibility study was carried out through clinical research examples.The P*Q*R*S constructed in this study is reasonable and practical,and can correct problems in the implementation process of the project and provide decision-making basis for the project management of relevant departments.
引文
[1]陈旻,莫楠.论研究者发起临床研究的伦理自律[J].中国医学伦理学,2017,30(5):563-566.
[2]MADEIRA C,PAIS A,KUBIA C,et al.Investigator-initiated clinical trials conducted by the portuguese clinical research infrastructure network(PtCRIN)[J].Contemp Clin Trials Commun,2016,4:141-148.
[3]SUVARN VR.Is there a need for investigator-initiated research?[J].Perspect Clin Res,2017,8(2):55-57.
[4]曹烨,王欣,曹玉,等.我国研究者发起的临床研究管理现况调查与分析[J].中国新药与临床杂志,2018,37(7):395-400.
[5]国家食品药品监督管理总局药品审评中心.已上市抗肿瘤药物增加新适应症技术指导原则[EB/OL].(2012-05-15)[2018-09-09].http://www.cde.org.cn/zdyz.do?method=largePage&id=143.
[6]BERGMAN L,BERNS B,DALGLEISH A,et al.Investigatorinitiated trials of targeted oncology agents:why independent research is at risk?[J].Ann oncol,2010,21(8):1573-1578.
[7]成方哲,刘素菊,张俊华.科技期刊同行评议问题分析与对策[J].编辑学报,2015,27(4):373-374.
[8]张宝生,吕宏迪.科研项目实施过程质量评价体系的构建[J].科技管理研究,2014,34(10):42-47.
[9]李睿,翁维良,易丹辉,等.中医临床研究过程质量控制评估指标的筛选及建立[J].中药新药与临床药理,2015,26(1):128-132.
[10]国家食品药品监督管理总局.《药物临床试验质量管理规范》(局令第3号)[EB/OL].(2003-08-06)[2018-09-09].http://samr.cfda.gov.cn/WS01/CL1031/24473.html.
[11]WHO.Guidelines for good clinical practice(GCP)for trials on pharmaceutical products[EB/OL].(1995)[2018-09-09].http://apps.who.int/medicinedocs/en/d/Jwhozip13e/7.4.html.
[12]ICH.Guideline for good clinical practice E6(R2)[EB/OL].(2016-12-01)[2018-09-09].http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/integrated-addendumgood-clinical-practice.html.
[13]《第三军医大学学报》编辑部.流行病学观察性研究报告规范---STROBE声明介绍[J].第三军医大学学报,2014,36(13):1444.
[14]周庆辉,陈红云,黄念.学术研究实施与报告和医学期刊编辑与发表的推荐规范[J].中国循证儿科杂志,2017,12(3):209-218.
[15]国家食品药品监督管理总局.药物临床试验数据现场核查要点[EB/OL].(2015-11-10)[2018-09-09].http://samr.cfda.gov.cn/WS01/CL0087/134440.html.
[16]谢崇波.高校基础研究评价体系初探[J].中国基础科学,2018,20(2):59-62.
[17]周晟,胡佳卉,孟庆刚.雷达图在中医药领域的应用探索[J].北京中医药大学学报,2018,41(1):9-13.
[18]徐秀娟,倪进东,王效军.基于二阶验证性因子分析的SF-36量表结构效度的分析[J].中国卫生统计,2013,30(6):846-848.
[19]周霞,曹晓岚,王兴臣,等.应用项目管理理念提高中医临床研究课题质量[J].中华中医药学刊,2010,28(7):1378-1379.
[2]MADEIRA C,PAIS A,KUBIA C,et al.Investigator-initiated clinical trials conducted by the portuguese clinical research infrastructure network(PtCRIN)[J].Contemp Clin Trials Commun,2016,4:141-148.
[3]SUVARN VR.Is there a need for investigator-initiated research?[J].Perspect Clin Res,2017,8(2):55-57.
[4]曹烨,王欣,曹玉,等.我国研究者发起的临床研究管理现况调查与分析[J].中国新药与临床杂志,2018,37(7):395-400.
[5]国家食品药品监督管理总局药品审评中心.已上市抗肿瘤药物增加新适应症技术指导原则[EB/OL].(2012-05-15)[2018-09-09].http://www.cde.org.cn/zdyz.do?method=largePage&id=143.
[6]BERGMAN L,BERNS B,DALGLEISH A,et al.Investigatorinitiated trials of targeted oncology agents:why independent research is at risk?[J].Ann oncol,2010,21(8):1573-1578.
[7]成方哲,刘素菊,张俊华.科技期刊同行评议问题分析与对策[J].编辑学报,2015,27(4):373-374.
[8]张宝生,吕宏迪.科研项目实施过程质量评价体系的构建[J].科技管理研究,2014,34(10):42-47.
[9]李睿,翁维良,易丹辉,等.中医临床研究过程质量控制评估指标的筛选及建立[J].中药新药与临床药理,2015,26(1):128-132.
[10]国家食品药品监督管理总局.《药物临床试验质量管理规范》(局令第3号)[EB/OL].(2003-08-06)[2018-09-09].http://samr.cfda.gov.cn/WS01/CL1031/24473.html.
[11]WHO.Guidelines for good clinical practice(GCP)for trials on pharmaceutical products[EB/OL].(1995)[2018-09-09].http://apps.who.int/medicinedocs/en/d/Jwhozip13e/7.4.html.
[12]ICH.Guideline for good clinical practice E6(R2)[EB/OL].(2016-12-01)[2018-09-09].http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/integrated-addendumgood-clinical-practice.html.
[13]《第三军医大学学报》编辑部.流行病学观察性研究报告规范---STROBE声明介绍[J].第三军医大学学报,2014,36(13):1444.
[14]周庆辉,陈红云,黄念.学术研究实施与报告和医学期刊编辑与发表的推荐规范[J].中国循证儿科杂志,2017,12(3):209-218.
[15]国家食品药品监督管理总局.药物临床试验数据现场核查要点[EB/OL].(2015-11-10)[2018-09-09].http://samr.cfda.gov.cn/WS01/CL0087/134440.html.
[16]谢崇波.高校基础研究评价体系初探[J].中国基础科学,2018,20(2):59-62.
[17]周晟,胡佳卉,孟庆刚.雷达图在中医药领域的应用探索[J].北京中医药大学学报,2018,41(1):9-13.
[18]徐秀娟,倪进东,王效军.基于二阶验证性因子分析的SF-36量表结构效度的分析[J].中国卫生统计,2013,30(6):846-848.
[19]周霞,曹晓岚,王兴臣,等.应用项目管理理念提高中医临床研究课题质量[J].中华中医药学刊,2010,28(7):1378-1379.