Practice and consideration of master protocol in clinical trials Article Swipe
Jiali Song
,
Zhiwei Rong
,
Xinwen Zhong
,
Yuhong Lu
,
Jike Huang
,
Yipei Yu
,
Zhilin Liu
,
Xuyuan Quan
,
Nana Chen
,
Kang Li
,
Fengyu Sun
,
Yan Hou
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.36922/td.342
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.36922/td.342
There is considerable interest in expediting late-stage therapy development by efficiently conducting trial designs that encompass multiple therapies or multiple subpopulations simultaneously within a unified protocol. Such trial designs are referred to as master protocols, with specific designs characterized by the terms umbrella, basket, or platform. These designs, in contrast to the traditional trial designs, are full of complexity. What factors should be considered in designing a trial ensuring the safety of human subjects and demonstrating the efficacy of new therapy? This paper overviews the master protocol framework, comprehensively unifies the definitions, and illustrates essential design elements of representative example trials conducted in drugs and medical devices. Besides, to understand the master protocols deeply, it is also a need to summarize the commonly-used types of master protocols in various disease and treatment fields, along with the reasons for these phenomena by analyzing the characteristics of the diseases, the mechanism of therapeutic products, and the principles of various types of master protocols. Finally, we also propose practical considerations, including the design, ethical, statistics, and funding considerations that arise from implementing complex master protocols. This information serves to guide practitioners in designing more effective trials and identifying potentially valuable therapies.
Related Topics
Concepts
Protocol (science)
Computer science
Variety (cybernetics)
Clinical trial
Risk analysis (engineering)
Protocol design
Clinical study design
Design elements and principles
Management science
Data science
Software engineering
Medicine
Communications protocol
Artificial intelligence
Engineering
Alternative medicine
Pathology
Operating system
Metadata
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- Language
- en
- Landing Page
- https://doi.org/10.36922/td.342
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https://openalex.org/W4376869607Canonical identifier for this work in OpenAlex
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https://doi.org/10.36922/td.342Digital Object Identifier
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Practice and consideration of master protocol in clinical trialsWork title
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articleOpenAlex work type
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enPrimary language
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2023Year of publication
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2023-04-28Full publication date if available
- Authors
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Jiali Song, Zhiwei Rong, Xinwen Zhong, Yuhong Lu, Jike Huang, Yipei Yu, Zhilin Liu, Xuyuan Quan, Nana Chen, Kang Li, Fengyu Sun, Yan HouList of authors in order
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https://doi.org/10.36922/td.342Publisher landing page
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YesWhether a free full text is available
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hybridOpen access status per OpenAlex
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https://doi.org/10.36922/td.342Direct OA link when available
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Protocol (science), Computer science, Variety (cybernetics), Clinical trial, Risk analysis (engineering), Protocol design, Clinical study design, Design elements and principles, Management science, Data science, Software engineering, Medicine, Communications protocol, Artificial intelligence, Engineering, Alternative medicine, Pathology, Operating systemTop concepts (fields/topics) attached by OpenAlex
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.basket, | 43 |
| abstract_inverted_index.complex | 179 |
| abstract_inverted_index.deeply, | 113 |
| abstract_inverted_index.design, | 169 |
| abstract_inverted_index.designs | 13, 28, 37 |
| abstract_inverted_index.disease | 129 |
| abstract_inverted_index.example | 99 |
| abstract_inverted_index.factors | 60 |
| abstract_inverted_index.fields, | 132 |
| abstract_inverted_index.funding | 173 |
| abstract_inverted_index.medical | 105 |
| abstract_inverted_index.propose | 164 |
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| abstract_inverted_index.unifies | 89 |
| abstract_inverted_index.various | 128, 156 |
| abstract_inverted_index.Besides, | 107 |
| abstract_inverted_index.Finally, | 161 |
| abstract_inverted_index.contrast | 49 |
| abstract_inverted_index.designs, | 47, 54 |
| abstract_inverted_index.devices. | 106 |
| abstract_inverted_index.efficacy | 77 |
| abstract_inverted_index.elements | 96 |
| abstract_inverted_index.ensuring | 68 |
| abstract_inverted_index.ethical, | 170 |
| abstract_inverted_index.interest | 3 |
| abstract_inverted_index.multiple | 16, 19 |
| abstract_inverted_index.protocol | 86 |
| abstract_inverted_index.referred | 30 |
| abstract_inverted_index.specific | 36 |
| abstract_inverted_index.subjects | 73 |
| abstract_inverted_index.therapy? | 80 |
| abstract_inverted_index.valuable | 196 |
| abstract_inverted_index.analyzing | 141 |
| abstract_inverted_index.conducted | 101 |
| abstract_inverted_index.designing | 65, 189 |
| abstract_inverted_index.diseases, | 146 |
| abstract_inverted_index.effective | 191 |
| abstract_inverted_index.encompass | 15 |
| abstract_inverted_index.essential | 94 |
| abstract_inverted_index.including | 167 |
| abstract_inverted_index.mechanism | 148 |
| abstract_inverted_index.overviews | 83 |
| abstract_inverted_index.phenomena | 139 |
| abstract_inverted_index.platform. | 45 |
| abstract_inverted_index.practical | 165 |
| abstract_inverted_index.products, | 151 |
| abstract_inverted_index.protocol. | 25 |
| abstract_inverted_index.protocols | 112, 126 |
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| abstract_inverted_index.therapies | 17 |
| abstract_inverted_index.treatment | 131 |
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| abstract_inverted_index.considered | 63 |
| abstract_inverted_index.expediting | 5 |
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| abstract_inverted_index.late-stage | 6 |
| abstract_inverted_index.principles | 154 |
| abstract_inverted_index.protocols, | 34 |
| abstract_inverted_index.protocols. | 160, 181 |
| abstract_inverted_index.therapies. | 197 |
| abstract_inverted_index.understand | 109 |
| abstract_inverted_index.complexity. | 58 |
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| abstract_inverted_index.considerations | 174 |
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| abstract_inverted_index.comprehensively | 88 |
| abstract_inverted_index.considerations, | 166 |
| cited_by_percentile_year | |
| countries_distinct_count | 0 |
| institutions_distinct_count | 12 |
| citation_normalized_percentile.value | 0.08104375 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |