Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis

Detalhes bibliográficos
Autor(a) principal: Gates, Allison
Data de Publicação: 2019
Outros Autores: Caldwell, Patrina, Curtis, Sarah, Dans, Leonila, Fernandes, Ricardo M., Hartling, Lisa, Kelly, Lauren E., Vandermeer, Ben, Williams, Katrina, Woolfall, Kerry, Dyson, Michele P.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10451/54297
Resumo: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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spelling Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysisData collectionEthicsGeneral paediatrics© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.Objectives: For 300 paediatric trials, we evaluated the reporting of: a data monitoring committee (DMC); interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints. Methods: For this cross-sectional evaluation, we randomly selected 300 paediatric trials published in 2012 from the Cochrane Central Register of Controlled Trials. We collected data on the reporting of a DMC; interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints. We reported the findings descriptively and stratified by trial characteristics. Results: Eighty-five (28%) of the trials investigated drugs, and 18% (n=55/300) reported a DMC. The reporting of a DMC was more common among multicentre than single centre trials (n=41/132, 31% vs n=14/139, 10%, p<0.001) and industry-sponsored trials compared with those sponsored by other sources (n=16/50, 32% vs n=39/250, 16%, p=0.009). Trials that reported a DMC enrolled more participants than those that did not (median [range]): 224 (10-60480) vs 91 (10-9528) (p<0.001). Only 25% of these trials reported interim analyses, and 42% reported stopping rules. Less than half (n=143/300, 48%) of trials reported on adverse events, and 72% (n=215/300) reported on harm-related endpoints. Trials that reported a DMC compared with those that did not were more likely to report adverse events (n=43/55, 78% vs 100/245, 41%, p<0.001) and harm-related endpoints (n=52/55, 95% vs. 163/245, 67%, p<0.001). Only 32% of drug trials reported a DMC; 18% and 19% did not report on adverse events or harm-related endpoints, respectively. Conclusions: The reporting of a DMC was infrequent, even among drug trials. Few trials reported stopping rules or interim analyses. Reporting of adverse events and harm-related endpoints was suboptimal.This work was supported by the Canadian Institutes of Health Research (#KRS 140989)BMJ Publishing GroupRepositório da Universidade de LisboaGates, AllisonCaldwell, PatrinaCurtis, SarahDans, LeonilaFernandes, Ricardo M.Hartling, LisaKelly, Lauren E.Vandermeer, BenWilliams, KatrinaWoolfall, KerryDyson, Michele P.2022-09-05T13:19:30Z20192019-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10451/54297engBMJ Paediatr Open. 2019 Mar 20;3(1):e00042610.1136/bmjpo-2018-0004262399-9772info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-11-08T16:59:53Zoai:repositorio.ul.pt:10451/54297Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T22:04:44.094028Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis
title Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis
spellingShingle Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis
Gates, Allison
Data collection
Ethics
General paediatrics
title_short Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis
title_full Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis
title_fullStr Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis
title_full_unstemmed Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis
title_sort Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis
author Gates, Allison
author_facet Gates, Allison
Caldwell, Patrina
Curtis, Sarah
Dans, Leonila
Fernandes, Ricardo M.
Hartling, Lisa
Kelly, Lauren E.
Vandermeer, Ben
Williams, Katrina
Woolfall, Kerry
Dyson, Michele P.
author_role author
author2 Caldwell, Patrina
Curtis, Sarah
Dans, Leonila
Fernandes, Ricardo M.
Hartling, Lisa
Kelly, Lauren E.
Vandermeer, Ben
Williams, Katrina
Woolfall, Kerry
Dyson, Michele P.
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Repositório da Universidade de Lisboa
dc.contributor.author.fl_str_mv Gates, Allison
Caldwell, Patrina
Curtis, Sarah
Dans, Leonila
Fernandes, Ricardo M.
Hartling, Lisa
Kelly, Lauren E.
Vandermeer, Ben
Williams, Katrina
Woolfall, Kerry
Dyson, Michele P.
dc.subject.por.fl_str_mv Data collection
Ethics
General paediatrics
topic Data collection
Ethics
General paediatrics
description © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
publishDate 2019
dc.date.none.fl_str_mv 2019
2019-01-01T00:00:00Z
2022-09-05T13:19:30Z
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/10451/54297
url http://hdl.handle.net/10451/54297
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv BMJ Paediatr Open. 2019 Mar 20;3(1):e000426
10.1136/bmjpo-2018-000426
2399-9772
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv BMJ Publishing Group
publisher.none.fl_str_mv BMJ Publishing Group
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
institution RCAAP
reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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