A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials
Autor(a) principal: | |
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Data de Publicação: | 2009 |
Outros Autores: | , |
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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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 |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
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RCAAP |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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