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Analysis of clinical and methodological characteristics of early COVID-19 treatment clinical trials

Bibliographic Details
Main Author: Mainoli, Beatrice
Publication Date: 2021
Other Authors: Machado, Tiago, Duarte, Gonçalo S., Prada, Luísa, Gonçalves, Nilza, Ferreira, Joaquim J., Costa, João
Format: Article
Language: eng
Source: Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
Download full: http://hdl.handle.net/10362/115954
Summary: Mainoli, B., Machado, T., Duarte, G. S., Prada, L., Gonçalves, N., Ferreira, J. J., & Costa, J. (2021). Analysis of clinical and methodological characteristics of early COVID-19 treatment clinical trials: so much work, so many lost opportunities. BMC Medical Research Methodology, 21(1), 1-10. [42]. https://doi.org/10.1186/s12874-021-01233-w
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spelling Analysis of clinical and methodological characteristics of early COVID-19 treatment clinical trialsso much work, so many lost opportunitiesClinical endpointsClinical trialsCOVID-19Meta-researchTrial methodologyEpidemiologyHealth InformaticsMainoli, B., Machado, T., Duarte, G. S., Prada, L., Gonçalves, N., Ferreira, J. J., & Costa, J. (2021). Analysis of clinical and methodological characteristics of early COVID-19 treatment clinical trials: so much work, so many lost opportunities. BMC Medical Research Methodology, 21(1), 1-10. [42]. https://doi.org/10.1186/s12874-021-01233-wBackground: The COVID-19 pandemic continues to rage on, and clinical research has been promoted worldwide. We aimed to assess the clinical and methodological characteristics of treatment clinical trials that have been set forth as an early response to the COVID-19 pandemic. Methods: First, we reviewed all registered clinical trials on COVID-19. The World Health Organization International Trials Registry Platform and national trial registries were searched for COVID-19 trials through April 19th, 2020. For each record, independent researchers extracted interventions, participants, and methodological characteristics. Second, on September 14th, 2020 we evaluated the recruitment status and availability of the results of COVID-19 treatment trials previously identified. Results: In April 2020, a total of 580 trials evaluating COVID-19 treatment were registered. Reporting quality was poor (core participant information was missing in 24.1 to 92.7%). Between 54.0 and 93.8% of the trials did not plan to include older people or those with a higher baseline risk. Most studies were randomised (67.9%), single-centre (58.3%), non-industry-funded (81.1%), to be conducted in China (47.6%), with a median duration of 184 days and a median sample size of 100 participants. Core endpoints (mortality, clinical status, and hospitalization length) were planned to be assessed in 5.2 to 13.1% of the trials. Five months later, 66 trials (11.4%) were reported as “Completed”, and only 46 (7.9%) had public results available. One hundred forty-four of 580 trials (24.8%) either had the status “Not yet recruiting” or “Suspended”, and 18 (3.1%) trials were prematurely stopped (“Terminated” or “Withdrawn”) The number of completed trials and trials with results are much lower than anticipated, considering the planned follow-up. Conclusions: Our results raise concerns about the success of the initial global research effort on COVID-19 treatment. The clinical and methodological characteristics of early COVID-19 treatment trials limit their capability to produce clear answers to critical questions in the shortest possible time.NOVA Information Management School (NOVA IMS)RUNMainoli, BeatriceMachado, TiagoDuarte, Gonçalo S.Prada, LuísaGonçalves, NilzaFerreira, Joaquim J.Costa, João2021-04-21T22:42:25Z2021-122021-12-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article10application/pdfhttp://hdl.handle.net/10362/115954engPURE: 29313066https://doi.org/10.1186/s12874-021-01233-winfo:eu-repo/semantics/openAccessreponame:Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)instname:FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiainstacron:RCAAP2024-05-22T17:52:02Zoai:run.unl.pt:10362/115954Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireinfo@rcaap.ptopendoar:https://opendoar.ac.uk/repository/71602025-05-28T17:23:00.540187Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) - FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiafalse
dc.title.none.fl_str_mv Analysis of clinical and methodological characteristics of early COVID-19 treatment clinical trials
so much work, so many lost opportunities
title Analysis of clinical and methodological characteristics of early COVID-19 treatment clinical trials
spellingShingle Analysis of clinical and methodological characteristics of early COVID-19 treatment clinical trials
Mainoli, Beatrice
Clinical endpoints
Clinical trials
COVID-19
Meta-research
Trial methodology
Epidemiology
Health Informatics
title_short Analysis of clinical and methodological characteristics of early COVID-19 treatment clinical trials
title_full Analysis of clinical and methodological characteristics of early COVID-19 treatment clinical trials
title_fullStr Analysis of clinical and methodological characteristics of early COVID-19 treatment clinical trials
title_full_unstemmed Analysis of clinical and methodological characteristics of early COVID-19 treatment clinical trials
title_sort Analysis of clinical and methodological characteristics of early COVID-19 treatment clinical trials
author Mainoli, Beatrice
author_facet Mainoli, Beatrice
Machado, Tiago
Duarte, Gonçalo S.
Prada, Luísa
Gonçalves, Nilza
Ferreira, Joaquim J.
Costa, João
author_role author
author2 Machado, Tiago
Duarte, Gonçalo S.
Prada, Luísa
Gonçalves, Nilza
Ferreira, Joaquim J.
Costa, João
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv NOVA Information Management School (NOVA IMS)
RUN
dc.contributor.author.fl_str_mv Mainoli, Beatrice
Machado, Tiago
Duarte, Gonçalo S.
Prada, Luísa
Gonçalves, Nilza
Ferreira, Joaquim J.
Costa, João
dc.subject.por.fl_str_mv Clinical endpoints
Clinical trials
COVID-19
Meta-research
Trial methodology
Epidemiology
Health Informatics
topic Clinical endpoints
Clinical trials
COVID-19
Meta-research
Trial methodology
Epidemiology
Health Informatics
description Mainoli, B., Machado, T., Duarte, G. S., Prada, L., Gonçalves, N., Ferreira, J. J., & Costa, J. (2021). Analysis of clinical and methodological characteristics of early COVID-19 treatment clinical trials: so much work, so many lost opportunities. BMC Medical Research Methodology, 21(1), 1-10. [42]. https://doi.org/10.1186/s12874-021-01233-w
publishDate 2021
dc.date.none.fl_str_mv 2021-04-21T22:42:25Z
2021-12
2021-12-01T00:00:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10362/115954
url http://hdl.handle.net/10362/115954
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv PURE: 29313066
https://doi.org/10.1186/s12874-021-01233-w
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 10
application/pdf
dc.source.none.fl_str_mv reponame:Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
instname:FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologia
instacron:RCAAP
instname_str FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologia
instacron_str RCAAP
institution RCAAP
reponame_str Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
collection Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
repository.name.fl_str_mv Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) - FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologia
repository.mail.fl_str_mv info@rcaap.pt
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