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Overview and applications of master protocol in clinical trials
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Yuan-ming MAO1, 3, Jin-qi ZHAN2, Rong-rong WANG3, Qiu-tang XIE1, Ying-ying DAI1, Shu-wei LIU1, Jin-yu ZHOU4, Hong-jia ZHU5, Jing MA6
Chinese Journal of New Drugs | 2021, 30(22) : 2083 - 2090
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Chinese Journal of New Drugs | 2021, 30(22): 2083-2090
Overview and applications of master protocol in clinical trials
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Yuan-ming MAO1, 3, Jin-qi ZHAN2, Rong-rong WANG3, Qiu-tang XIE1, Ying-ying DAI1, Shu-wei LIU1, Jin-yu ZHOU4, Hong-jia ZHU5, Jing MA6
Affiliations
  • 1Columbia University Mailman School of Public Health, New York 10032, United States
  • 2Yiviva Inc., New York 10013, United States
  • 3U. S.-China Health Summit, Massachusetts 02142, United States
  • 4Cavendish Laboratory, University of Cambridge, Cambridge CB3 0HE, United Kingdom
  • 5Department of Chemistry, University of Cambridge, Cambridge CB2 1EW, United Kingdom
  • 6Active Health and Translational Medicine Center, Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital, Chengdu 610072, China
Published: 2021-11-30
Outline
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Master protocol is a novel and more efficient design for clinical trial research than the traditional clinical trials. Usually a master protocol includes several sub-protocols which could investigate treatment effects of a single drug on several diseases or multiple drugs targeting a single disorder. This review compared master protocol with traditional trials in terms of the research design principle, application, and procedure flow as well as advantages and limitations. We also presented some examples of ongoing applications of master protocol designs including treatment of COVID-19 related illness. Finally, we discussed about potential implementation of master protocol in China especially under the COVID-19 pandemic with an evaluation on the relevant opportunities and challenges.

clinical trial  /  master protocol  /  coronavirus disease  /  drug research and development  /  clinical research
毛元铭, 詹瑨祺, 王榕榕, 谢秋堂, 戴英莹, 刘姝玮, 周瑾瑜, 朱鸿嘉, 马晶. 临床医学试验主方案概述及其应用. 中国新药杂志, 2021 , 30 (22) : 2083 -2090 .
Yuan-ming MAO, Jin-qi ZHAN, Rong-rong WANG, Qiu-tang XIE, Ying-ying DAI, Shu-wei LIU, Jin-yu ZHOU, Hong-jia ZHU, Jing MA. Overview and applications of master protocol in clinical trials[J]. Chinese Journal of New Drugs, 2021 , 30 (22) : 2083 -2090 .
Year 2021 volume 30 Issue 22
32
6
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  • Online Date:2026-10-28
  • Published:2021-11-30
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  • Accepted:2021-08-26
Affiliations
    1Columbia University Mailman School of Public Health, New York 10032, United States
    2Yiviva Inc., New York 10013, United States
    3U. S.-China Health Summit, Massachusetts 02142, United States
    4Cavendish Laboratory, University of Cambridge, Cambridge CB3 0HE, United Kingdom
    5Department of Chemistry, University of Cambridge, Cambridge CB2 1EW, United Kingdom
    6Active Health and Translational Medicine Center, Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital, Chengdu 610072, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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