多囊卵巢综合征不孕症临床试验偏离方案情况分析及应对策略
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摘要
药物临床试验设计和实施应遵循临床试验管理规范及标准操作规程的相关要求,尽可能减少试验中偏离方案和违反方案的发生,但在实施过程中偏离试验方案却难以避免。介绍方案偏离的定义及分类,认为常见的原因多来源于受试者因素、研究者因素、试验组织者因素,偏离方案的轻重将对研究结果产生不同程度的影响。以多囊卵巢综合征不孕症中医药临床研究为例,对试验过程中偏离方案的基本情况进行分析,提出解决策略,以期为提升中医临床试验研究质量提供思路。
The design and implementation of drug clinical trials should follow the relevant requirements of clinical trial management norms and standard operating procedures,minimize the occurrence of deviations and violations in the trial,but it is difficult to avoid deviation from the experimental scheme during the implementation process. This paper introduced the definition and classification of program deviations. It is believed that the common causes are mostly from the subject factors,the researcher factors,and the trial organizer factors. The weight of the deviation scheme will have different effects on the research results. Taking the clinical research on traditional Chinese medicine( TCM) infertility in polycystic ovary syndrome as an example,the basic situation of the deviation program in the test process was analyzed,and the solution strategy was proposed to provide ideas for improving the quality of TCM clinical trial research.
The design and implementation of drug clinical trials should follow the relevant requirements of clinical trial management norms and standard operating procedures,minimize the occurrence of deviations and violations in the trial,but it is difficult to avoid deviation from the experimental scheme during the implementation process. This paper introduced the definition and classification of program deviations. It is believed that the common causes are mostly from the subject factors,the researcher factors,and the trial organizer factors. The weight of the deviation scheme will have different effects on the research results. Taking the clinical research on traditional Chinese medicine( TCM) infertility in polycystic ovary syndrome as an example,the basic situation of the deviation program in the test process was analyzed,and the solution strategy was proposed to provide ideas for improving the quality of TCM clinical trial research.
引文
[1]沈文娟,张跃辉,张多加,等.国际临床试验规范化实施过程及其在中医药领域的应用[J].中医杂志,2018,59(8):649-653.
[2]高敬书,吴效科,马红丽,等.大型不孕症临床试验的质量控制与方案依从性事件[J].中华中医药杂志,2018,33(8):3666-3670.
[3]陆芳,李睿,张菀桐,等.基于量化评价的临床研究过程质量控制及其案例分析[J].中医杂志,2017,10(19):1641-1645.
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[5]李见明,孙振球,高荣,等.我国药物临床试验的现状与发展方向[J].中国临床药理学杂志,2013,29(6):473-476.
[6]吴翠云,曹国英,伍蓉,等.临床试验伦理委员会对临床研究中不依从/违背或偏离方案报告的管理[J].中国医学伦理学,2018,31(3):328-331.
[7]朱俊.如何在中国开展临床试验(二):一个临床研究者的经验分享[J].中国处方药,2010,103(10):10-17.
[8]卜擎燕,谢立群,熊宁宁.临床试验中偏离方案的管理[J].中国新药杂志,2012,21(18):2121-2125.
[9]朱赛楠,于永沛,阎小妍,等.新药临床试验数据盲态审核中常见方案偏离情况分析[J].中国新药杂志,2012,21(3):283-288.
[10]BRINKMAN-DENNEY S.An international comparison of the clinical trials nurse role[J].Nurs Manag(Harrow),2013,20(8):32-40.
[11]VEAL GJ,MALIK S,LUPO M,et al.Investigating the roles and training of paediatric research nurses working across Europe:a questionnaire-based survey[J].BMJPaediatr Open,2017,1(1):e000170.
[12]张琳,曾涛,张炜.美国食品和药物管理局针对临床试验研究者发出警告信的分析[J].中国新药与临床杂志,2017,36(8):451-454.
[13]SHETTY YC,SAIYED AA.Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators,institutional review boards and Sponsors:a retrospective study[J].J Med Ethics,2015,41(5):398-403.
[14]WU XK,WANG YY,LIU JP,et al.Randomized controlled trial of letrozole,berberine,or a combination for infertility in the polycystic ovary syndrome[J].Fertil Steril,2016,106(3):757-765.
[15]LI Y,KUANG H,SHEN W,et al.Letrozole,berberine,or a combination for infertility in Chinese women with polycystic ovary syndrome:a multicentre,randomised,double-blind,placebo-controlled trial[J].Lancet,2015,386:S70.doi:10.1016/S0140-6736(15)00651-0.
[16]谢婷,王子寿,何韦静.临床试验药物管理规范性要点探讨[J].中药与临床,2015,6(1):45-57.
[17]SAJDAK R,TREMBATH L,THOMAS KS.The importance of standard operating procedures in clinical trials[J].J Nucl Med Technol,2013,41(3):231-233.
[18]沈文娟,吴效科,刘建平.中医药多中心随机对照试验实施过程质量控制的经验体会[J].现代中医临床,2014,21(3):23-26.
[19]刘峘,谢雁鸣,翁维良.国家科技支撑计划课题的现场监查[J].中医杂志,2010,10(S1):8-9.
[2]高敬书,吴效科,马红丽,等.大型不孕症临床试验的质量控制与方案依从性事件[J].中华中医药杂志,2018,33(8):3666-3670.
[3]陆芳,李睿,张菀桐,等.基于量化评价的临床研究过程质量控制及其案例分析[J].中医杂志,2017,10(19):1641-1645.
[4]吉萍.中国药物临床试验的质量管理[J].中国新药杂志,2013,22(1):13-16.
[5]李见明,孙振球,高荣,等.我国药物临床试验的现状与发展方向[J].中国临床药理学杂志,2013,29(6):473-476.
[6]吴翠云,曹国英,伍蓉,等.临床试验伦理委员会对临床研究中不依从/违背或偏离方案报告的管理[J].中国医学伦理学,2018,31(3):328-331.
[7]朱俊.如何在中国开展临床试验(二):一个临床研究者的经验分享[J].中国处方药,2010,103(10):10-17.
[8]卜擎燕,谢立群,熊宁宁.临床试验中偏离方案的管理[J].中国新药杂志,2012,21(18):2121-2125.
[9]朱赛楠,于永沛,阎小妍,等.新药临床试验数据盲态审核中常见方案偏离情况分析[J].中国新药杂志,2012,21(3):283-288.
[10]BRINKMAN-DENNEY S.An international comparison of the clinical trials nurse role[J].Nurs Manag(Harrow),2013,20(8):32-40.
[11]VEAL GJ,MALIK S,LUPO M,et al.Investigating the roles and training of paediatric research nurses working across Europe:a questionnaire-based survey[J].BMJPaediatr Open,2017,1(1):e000170.
[12]张琳,曾涛,张炜.美国食品和药物管理局针对临床试验研究者发出警告信的分析[J].中国新药与临床杂志,2017,36(8):451-454.
[13]SHETTY YC,SAIYED AA.Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators,institutional review boards and Sponsors:a retrospective study[J].J Med Ethics,2015,41(5):398-403.
[14]WU XK,WANG YY,LIU JP,et al.Randomized controlled trial of letrozole,berberine,or a combination for infertility in the polycystic ovary syndrome[J].Fertil Steril,2016,106(3):757-765.
[15]LI Y,KUANG H,SHEN W,et al.Letrozole,berberine,or a combination for infertility in Chinese women with polycystic ovary syndrome:a multicentre,randomised,double-blind,placebo-controlled trial[J].Lancet,2015,386:S70.doi:10.1016/S0140-6736(15)00651-0.
[16]谢婷,王子寿,何韦静.临床试验药物管理规范性要点探讨[J].中药与临床,2015,6(1):45-57.
[17]SAJDAK R,TREMBATH L,THOMAS KS.The importance of standard operating procedures in clinical trials[J].J Nucl Med Technol,2013,41(3):231-233.
[18]沈文娟,吴效科,刘建平.中医药多中心随机对照试验实施过程质量控制的经验体会[J].现代中医临床,2014,21(3):23-26.
[19]刘峘,谢雁鸣,翁维良.国家科技支撑计划课题的现场监查[J].中医杂志,2010,10(S1):8-9.
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