Platform trials to evaluate the benefit-risk of COVID-19 therapeutics : Successes, learnings, and recommendations for future pandemics
Copyright © 2023 Elsevier Inc. All rights reserved..
BACKGROUND: In response to the COVID-19 global pandemic, multiple platform trials were initiated to accelerate evidence generation of potential therapeutic interventions. Given a rapidly evolving and dynamic pandemic, platform trials have a key advantage over traditional randomized trials: multiple interventions can be investigated under a master protocol sharing a common infrastructure.
METHODS: This paper focuses on nine platform trials that were instrumental in advancing care in COVID-19 in the hospital and community setting. A semi-structured qualitative interview was conducted with the principal investigators and lead statisticians of these trials. Information from the interviews and public sources were tabulated and summarized across trials, and recommendations for best practice for the next health crisis are provided.
RESULTS: Based on the information gathered takeaways were identified as 1) the existence of some aspect of trial design or conduct (e.g., existing network of investigators or colleagues, infrastructure for data capture and relevant statistical expertise) was a key success factor; 2) the choice of treatments (e.g., repurposed drugs) had major impact on the trials as did the choice of primary endpoint; and 3) the lack of coordination across trials was flagged as an area for improvement.
CONCLUSION: These trials deployed during the COVID-19 pandemic demonstrate how to achieve both speed and quality of evidence generation regarding clinical benefit (or not) of existing therapies to treat new pathogens in a pandemic setting. As a group, these trials identified treatments that worked, and many that did not, in a matter of months.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:132 |
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| Enthalten in: |
Contemporary clinical trials - 132(2023) vom: 15. Sept., Seite 107292 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Buenconsejo, Joan [VerfasserIn] |
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| Anmerkungen: |
Date Completed 04.09.2023 Date Revised 06.09.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.cct.2023.107292 |
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| Förderinstitution / Projekttitel: |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: In response to the COVID-19 global pandemic, multiple platform trials were initiated to accelerate evidence generation of potential therapeutic interventions. Given a rapidly evolving and dynamic pandemic, platform trials have a key advantage over traditional randomized trials: multiple interventions can be investigated under a master protocol sharing a common infrastructure | ||
| 520 | |a METHODS: This paper focuses on nine platform trials that were instrumental in advancing care in COVID-19 in the hospital and community setting. A semi-structured qualitative interview was conducted with the principal investigators and lead statisticians of these trials. Information from the interviews and public sources were tabulated and summarized across trials, and recommendations for best practice for the next health crisis are provided | ||
| 520 | |a RESULTS: Based on the information gathered takeaways were identified as 1) the existence of some aspect of trial design or conduct (e.g., existing network of investigators or colleagues, infrastructure for data capture and relevant statistical expertise) was a key success factor; 2) the choice of treatments (e.g., repurposed drugs) had major impact on the trials as did the choice of primary endpoint; and 3) the lack of coordination across trials was flagged as an area for improvement | ||
| 520 | |a CONCLUSION: These trials deployed during the COVID-19 pandemic demonstrate how to achieve both speed and quality of evidence generation regarding clinical benefit (or not) of existing therapies to treat new pathogens in a pandemic setting. As a group, these trials identified treatments that worked, and many that did not, in a matter of months | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Platform trials | |
| 650 | 4 | |a Repurposed drugs | |
| 700 | 1 | |a Liao, Ran |e verfasserin |4 aut | |
| 700 | 1 | |a Lin, Junjing |e verfasserin |4 aut | |
| 700 | 1 | |a Singh, Pritibha |e verfasserin |4 aut | |
| 700 | 1 | |a Cooner, Freda |e verfasserin |4 aut | |
| 700 | 1 | |a Ghosh, Samiran |e verfasserin |4 aut | |
| 700 | 1 | |a Gamalo, Margaret |e verfasserin |4 aut | |
| 700 | 1 | |a Russek-Cohen, Estelle |e verfasserin |4 aut | |
| 700 | 1 | |a Zariffa, Névine |e verfasserin |4 aut | |
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