非酒精性脂肪性肝炎新药探索性和确证性临床试验方案设计中需重点关注的问题

茅益民

doi:10.3969/j.issn.1001-5256.2018.12.005

非酒精性脂肪性肝炎新药探索性和确证性临床试验方案设计中需重点关注的问题

DOI: 10.3969/j.issn.1001-5256.2018.12.005

茅益民

上海交通大学医学院附属仁济医院,上海市消化疾病研究所,上海市脂肪性肝病诊治研究中心,上海交通大学医学院临床研究中心

基金项目:

十三五科技重大专项(2017ZX09304016)；国家自然科学基金(81670524)；上海交通大学医学院多中心临床研究项目(DLY201607)；上海申康医院发展中心临床创新三年行动计划(16CR2009A)；

详细信息

中图分类号: R575.1
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出版历程
- 出版日期: 2018-12-20

Important issues in protocol design of exploratory and confirmatory clinical trials of new drugs for nonalcoholic steatohepatitis

Mao YiMin

Research funding:

摘要

摘要: 非酒精性脂肪性肝炎的新药研发是目前肝病领域的研究热点。确证性临床试验是新药注册的关键临床试验,而探索性临床试验通常为确证性临床试验提供依据。由于不同阶段的试验目的不同,方案制订的要求、策略并不完全一致。试验设计应兼顾伦理学和科学性。良好的设计需综合考虑临床试验的方法学、药物研发整体策略、研究的新药以及目标适应证,NASH的相关临床流行病学、诊断和评估等问题。
- 肝炎,酒精性 /
- 临床试验 /
- 方案评价
Abstract: The research and development of new drugs for nonalcoholic steatohepatitis (NASH) is a research hotspot in the field of liver diseases. Confirmatory clinical trials are the key clinical trials for new drug registration, while exploratory clinical trials usually provide a basis for confirmatory clinical trials. Due to different objectives of clinical trials in different phases, there are different requirements and strategies for protocol design. Trial design should take into account both ethics and scientificity. Good protocol design needs to consider the methodology of clinical trials, the overall strategy for drug research and development, new drugs under research and their target indications, and clinical epidemiology, diagnosis, and evaluation of NASH.
- hepatitis, non-alcoholic fatty liver /
- clinical trial /
- program evaluation

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参考文献(12)

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