Semantic and Geographical Analysis of COVID-19 Trials Reveals a Fragmented Clinical Research Landscape Likely to Impair Informativeness
Background: The unprecedented impact of the COVID-19 pandemic on modern society has ignited a “gold rush” for effective treatment and diagnostic strategies, with a significant diversion of economic, scientific, and human resources toward dedicated clinical research. We aimed to describe trends in th...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2020-06-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fmed.2020.00367/full |
| _version_ | 1819060677845712896 |
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| author | Giulia Tini Bruno Achutti Duso Federica Bellerba Federica Corso Sara Gandini Saverio Minucci Pier Giuseppe Pelicci Pier Giuseppe Pelicci Luca Mazzarella Luca Mazzarella |
| author_facet | Giulia Tini Bruno Achutti Duso Federica Bellerba Federica Corso Sara Gandini Saverio Minucci Pier Giuseppe Pelicci Pier Giuseppe Pelicci Luca Mazzarella Luca Mazzarella |
| author_sort | Giulia Tini |
| collection | DOAJ |
| description | Background: The unprecedented impact of the COVID-19 pandemic on modern society has ignited a “gold rush” for effective treatment and diagnostic strategies, with a significant diversion of economic, scientific, and human resources toward dedicated clinical research. We aimed to describe trends in this rapidly changing landscape to inform adequate resource allocation.Methods: We developed an online repository (COVID Trial Monitor) to analyze in real time the growth rate, geographical distribution, and characteristics of COVID-19 related trials. We defined structured semantic ontologies with controlled vocabularies to categorize trial interventions, study endpoints, and study designs. Analyses are publicly available at https://bioinfo.ieo.it/shiny/app/CovidCT.Results: We observe a clear prevalence of monocentric trials with highly heterogeneous endpoints and a significant disconnect between geographic distribution and disease prevalence, implying that most countries would need to recruit unrealistic percentages of their total prevalent cases to fulfill enrolment.Conclusions: This geographically and methodologically incoherent growth casts doubts on the actual feasibility of locally reaching target sample sizes and the probability of most of these trials providing reliable and transferable results. We call for the harmonization of clinical trial design criteria for COVID-19 and the increased use of larger master protocols incorporating elements of adaptive designs. COVID Trial Monitor identifies critical issues in current COVID-19-related clinical research and represents a useful resource with which researchers and policymakers can improve the quality and efficiency of related trials. |
| first_indexed | 2024-12-21T14:30:48Z |
| format | Article |
| id | doaj.art-1521cd968aef43509c454dbd80681587 |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-12-21T14:30:48Z |
| publishDate | 2020-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj.art-1521cd968aef43509c454dbd806815872022-12-21T19:00:29ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2020-06-01710.3389/fmed.2020.00367562105Semantic and Geographical Analysis of COVID-19 Trials Reveals a Fragmented Clinical Research Landscape Likely to Impair InformativenessGiulia Tini0Bruno Achutti Duso1Federica Bellerba2Federica Corso3Sara Gandini4Saverio Minucci5Pier Giuseppe Pelicci6Pier Giuseppe Pelicci7Luca Mazzarella8Luca Mazzarella9Department of Experimental Oncology, IEO European Institute of Oncology IRCSS, Milan, ItalyDepartment of Experimental Oncology, IEO European Institute of Oncology IRCSS, Milan, ItalyDepartment of Experimental Oncology, IEO European Institute of Oncology IRCSS, Milan, ItalyDepartment of Experimental Oncology, IEO European Institute of Oncology IRCSS, Milan, ItalyDepartment of Experimental Oncology, IEO European Institute of Oncology IRCSS, Milan, ItalyDepartment of Experimental Oncology, IEO European Institute of Oncology IRCSS, Milan, ItalyDepartment of Experimental Oncology, IEO European Institute of Oncology IRCSS, Milan, ItalyDepartment of Hemato-Oncology, University of Milan, Milan, ItalyDepartment of Experimental Oncology, IEO European Institute of Oncology IRCSS, Milan, ItalyDivision of Early Drug Development for Innovative Therapies, IEO European Institute of Oncology IRCCS, Milan, ItalyBackground: The unprecedented impact of the COVID-19 pandemic on modern society has ignited a “gold rush” for effective treatment and diagnostic strategies, with a significant diversion of economic, scientific, and human resources toward dedicated clinical research. We aimed to describe trends in this rapidly changing landscape to inform adequate resource allocation.Methods: We developed an online repository (COVID Trial Monitor) to analyze in real time the growth rate, geographical distribution, and characteristics of COVID-19 related trials. We defined structured semantic ontologies with controlled vocabularies to categorize trial interventions, study endpoints, and study designs. Analyses are publicly available at https://bioinfo.ieo.it/shiny/app/CovidCT.Results: We observe a clear prevalence of monocentric trials with highly heterogeneous endpoints and a significant disconnect between geographic distribution and disease prevalence, implying that most countries would need to recruit unrealistic percentages of their total prevalent cases to fulfill enrolment.Conclusions: This geographically and methodologically incoherent growth casts doubts on the actual feasibility of locally reaching target sample sizes and the probability of most of these trials providing reliable and transferable results. We call for the harmonization of clinical trial design criteria for COVID-19 and the increased use of larger master protocols incorporating elements of adaptive designs. COVID Trial Monitor identifies critical issues in current COVID-19-related clinical research and represents a useful resource with which researchers and policymakers can improve the quality and efficiency of related trials.https://www.frontiersin.org/article/10.3389/fmed.2020.00367/fullCOVIDtrialgeographyendpointdesign |
| spellingShingle | Giulia Tini Bruno Achutti Duso Federica Bellerba Federica Corso Sara Gandini Saverio Minucci Pier Giuseppe Pelicci Pier Giuseppe Pelicci Luca Mazzarella Luca Mazzarella Semantic and Geographical Analysis of COVID-19 Trials Reveals a Fragmented Clinical Research Landscape Likely to Impair Informativeness Frontiers in Medicine COVID trial geography endpoint design |
| title | Semantic and Geographical Analysis of COVID-19 Trials Reveals a Fragmented Clinical Research Landscape Likely to Impair Informativeness |
| title_full | Semantic and Geographical Analysis of COVID-19 Trials Reveals a Fragmented Clinical Research Landscape Likely to Impair Informativeness |
| title_fullStr | Semantic and Geographical Analysis of COVID-19 Trials Reveals a Fragmented Clinical Research Landscape Likely to Impair Informativeness |
| title_full_unstemmed | Semantic and Geographical Analysis of COVID-19 Trials Reveals a Fragmented Clinical Research Landscape Likely to Impair Informativeness |
| title_short | Semantic and Geographical Analysis of COVID-19 Trials Reveals a Fragmented Clinical Research Landscape Likely to Impair Informativeness |
| title_sort | semantic and geographical analysis of covid 19 trials reveals a fragmented clinical research landscape likely to impair informativeness |
| topic | COVID trial geography endpoint design |
| url | https://www.frontiersin.org/article/10.3389/fmed.2020.00367/full |
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