生物等效性临床试验的伦理审查要点
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摘要
生物等效性临床试验在药物研发和上市过程中发挥着非常重要的作用,伦理委员会审查的目的是保护研究受试者的权益和福利,从临床试验方案、知情同意书及实施过程、招募广告、研究者资质和实施环境、风险与获益的评估等方面详细阐述了生物等效性临床试验的伦理审查重点。通过对生物等效性临床试验伦理审查共性问题和特别关注内容的初步总结与分析,提出伦理委员会审查要点的建议,以期提高我国生物等效性研究的伦理审查水平,保证医学研究的健康发展。
Bioequivalence clinical trial plays a very important role in drug development and marketing.The purpose of the ethics committee review is to protect the rights and welfare of research subjects. This paper elaborated the key points of ethical review of bioequivalence clinical trials from the aspects of clinical trial plan, informed consent and implementation process, recruitment advertisement, researcher qualification and implementation environment, risk/benefit evaluation, etc. Based on the preliminary summary and analysis of the common problems and special concerns in ethical review of bioequivalence clinical trials, this paper put forward some suggestions on the review points of ethical committee in order to improve the level of ethical review of bioequivalence research in China and ensure the healthy development of medical research.
Bioequivalence clinical trial plays a very important role in drug development and marketing.The purpose of the ethics committee review is to protect the rights and welfare of research subjects. This paper elaborated the key points of ethical review of bioequivalence clinical trials from the aspects of clinical trial plan, informed consent and implementation process, recruitment advertisement, researcher qualification and implementation environment, risk/benefit evaluation, etc. Based on the preliminary summary and analysis of the common problems and special concerns in ethical review of bioequivalence clinical trials, this paper put forward some suggestions on the review points of ethical committee in order to improve the level of ethical review of bioequivalence research in China and ensure the healthy development of medical research.
引文
[1] 庞建新,吴婷,许重远,等.我国仿制药人体生物等效性临床试验研究室建设的现状与发展路径[J].药学进展,2016(12):883-889.
[2] CIOMS.International Ethical Guidelines for Health-related Research Involving Humans[Z].2016.
[3] 周吉银,邓璠,刘丹,等.我国医学伦理委员会存在的问题及建议[J].中国临床药理学杂志,2017,33(4):365-368.
[4] Yu L X,Li B V.FDA Bioequivalence Standards[M].Berlin:Springer,2014:465.
[5] 国家药典委员会.中华人民共和国药典(四部)[M].2015年版.北京:中国医药科技出版社,2015.
[6] 齐翔.药品注册生物等效性试验中常见问题[J].当代化工研究,2018(3):169-170.
[7] 刘璨,魏静.长消除半衰期药物的生物等效性研究现状[J].天津医科大学学报,2012,18(3):395-398.
[8] 张煊,闫冬,高静,等.高变异药物生物等效性评价中多组试验的设计及统计分析[J].中国临床药理学与治疗学,2015,20(10):1115-1121.
[9] Gallin JohnI.临床研究规范与准则:伦理与法规[M].北京:科学出版社,2013.
[10] 胡晋红.医学研究知情同意过程及信息告知的伦理审查要点[J].药学服务与研究,2014,14(3):166-169.
[11] 耿雯倩,任静,祝延红,等.临床试验中招募广告的伦理审查与规范管理[J].中国医学伦理学,2018,31(3):332-334.
[12] 林颖,周谏开.关于加强临床试验招募广告伦理审查的探讨[J].中国处方药,2014(9):1-3.
[2] CIOMS.International Ethical Guidelines for Health-related Research Involving Humans[Z].2016.
[3] 周吉银,邓璠,刘丹,等.我国医学伦理委员会存在的问题及建议[J].中国临床药理学杂志,2017,33(4):365-368.
[4] Yu L X,Li B V.FDA Bioequivalence Standards[M].Berlin:Springer,2014:465.
[5] 国家药典委员会.中华人民共和国药典(四部)[M].2015年版.北京:中国医药科技出版社,2015.
[6] 齐翔.药品注册生物等效性试验中常见问题[J].当代化工研究,2018(3):169-170.
[7] 刘璨,魏静.长消除半衰期药物的生物等效性研究现状[J].天津医科大学学报,2012,18(3):395-398.
[8] 张煊,闫冬,高静,等.高变异药物生物等效性评价中多组试验的设计及统计分析[J].中国临床药理学与治疗学,2015,20(10):1115-1121.
[9] Gallin JohnI.临床研究规范与准则:伦理与法规[M].北京:科学出版社,2013.
[10] 胡晋红.医学研究知情同意过程及信息告知的伦理审查要点[J].药学服务与研究,2014,14(3):166-169.
[11] 耿雯倩,任静,祝延红,等.临床试验中招募广告的伦理审查与规范管理[J].中国医学伦理学,2018,31(3):332-334.
[12] 林颖,周谏开.关于加强临床试验招募广告伦理审查的探讨[J].中国处方药,2014(9):1-3.