A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials

Detalhes bibliográficos
Autor(a) principal: Fernandes, Ricardo M.
Data de Publicação: 2009
Outros Autores: van der Lee, Johanna H., Offringa, Martin
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10451/48267
Resumo: © 2009 Fernandes et al; licensee BioMed Central Ltd. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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spelling A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials© 2009 Fernandes et al; licensee BioMed Central Ltd. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Background: Decisions about interim analysis and early stopping of clinical trials, as based on recommendations of Data Monitoring Committees (DMCs), have far reaching consequences for the scientific validity and clinical impact of a trial. Our aim was to evaluate the frequency and quality of the reporting on DMC composition and roles, interim analysis and early termination in pediatric trials. Methods: We conducted a systematic review of randomized controlled clinical trials published from 2005 to 2007 in a sample of four general and four pediatric journals. We used full-text databases to identify trials which reported on DMCs, interim analysis or early termination, and included children or adolescents. Information was extracted on general trial characteristics, risk of bias, and a set of parameters regarding DMC composition and roles, interim analysis and early termination. Results: 110 of the 648 pediatric trials in this sample (17%) reported on DMC or interim analysis or early stopping, and were included; 68 from general and 42 from pediatric journals. The presence of DMCs was reported in 89 of the 110 included trials (81%); 62 papers, including 46 of the 89 that reported on DMCs (52%), also presented information about interim analysis. No paper adequately reported all DMC parameters, and nine (15%) reported all interim analysis details. Of 32 trials which terminated early, 22 (69%) did not report predefined stopping guidelines and 15 (47%) did not provide information on statistical monitoring methods. Conclusions: Reporting on DMC composition and roles, on interim analysis results and on early termination of pediatric trials is incomplete and heterogeneous. We propose a minimal set of reporting parameters that will allow the reader to assess the validity of trial results.Springer NatureRepositório da Universidade de LisboaFernandes, Ricardo M.van der Lee, Johanna H.Offringa, Martin2021-05-31T15:07:27Z20092009-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10451/48267engBMC Pediatr. 2009 Dec 13;9:77.10.1186/1471-2431-9-771471-2431info: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:RCAAP2023-11-08T16:51:33Zoai:repositorio.ul.pt:10451/48267Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T22:00:10.777240Repositório 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 A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials
title A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials
spellingShingle A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials
Fernandes, Ricardo M.
title_short A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials
title_full A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials
title_fullStr A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials
title_full_unstemmed A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials
title_sort A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials
author Fernandes, Ricardo M.
author_facet Fernandes, Ricardo M.
van der Lee, Johanna H.
Offringa, Martin
author_role author
author2 van der Lee, Johanna H.
Offringa, Martin
author2_role author
author
dc.contributor.none.fl_str_mv Repositório da Universidade de Lisboa
dc.contributor.author.fl_str_mv Fernandes, Ricardo M.
van der Lee, Johanna H.
Offringa, Martin
description © 2009 Fernandes et al; licensee BioMed Central Ltd. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
publishDate 2009
dc.date.none.fl_str_mv 2009
2009-01-01T00:00:00Z
2021-05-31T15:07:27Z
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/10451/48267
url http://hdl.handle.net/10451/48267
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv BMC Pediatr. 2009 Dec 13;9:77.
10.1186/1471-2431-9-77
1471-2431
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 Springer Nature
publisher.none.fl_str_mv Springer Nature
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
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