Portuguese Authorship in Published Clinical Trials: Differences in Industry and Investigator Initiated Trials

Detalhes bibliográficos
Autor(a) principal: Pinheiro Andrade, Maria
Data de Publicação: 2021
Outros Autores: Matias, Daniela, Batuca, Joana, Gouveia, Nélia, Mota-Filipe, Hélder, Carreira Monteiro, Emília, Madeira, Catarina
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/14554
Resumo: Introduction: The aim of this study was to investigate the Portuguese authorship in publications resulting from trials initiated by the industry or investigators and run in Portugal.Material and Methods: Clinical trials with Portuguese institutions as sponsor or recruiting centers, and registered in four clinical trial registries, in the last 14 years, were assessed. Publications of completed trials, from both the initiative of the industry and investigatorswere screened and compared.Results: The percentage of published trials initiated by industry and investigators was similar (28.0%). However, the percentage of completed investigator-initiated trials (43.6%) was lower when compared to industry trials (69.7%). There was a higher percentage of Portuguese authorship in published investigator-initiated trials when compared with industry-initiated trials (47.1% vs 8.5%, respectively). Moreover, industry-initiated trials with Portuguese authors were published in journals with lower journal impact factor when compared with those published without authorship of Portuguese investigators. Oncology was the therapeutic area with the highest number of clinical trial registrations and publications. However, in publications with Portuguese authors, industry Initiated trials mainly focused on neurology while investigator-initiated trials had a higher number of papers in the fields of gastroenterology and infection diseases. Published trials with Portuguese authorship, initiated by the industry or investigators, also targeted different populations and had different purposes. In both cases, no significant differences were observed in terms of the journal impact factor or in the alignment of the published randomized trials with the respective reporting guidelines.Discussion: When compared with previous publications, this study showed an increasing trend in the number of clinical trials in Portugal, published within similar timeframes, after trial conclusion. Even though both industry and investigator trials are published within the standards for reporting trials, the low number of Portuguese authorships in industry publications might underline the need for invigorating these independent clinical trials in Portugal by capacitating and empowering national clinical research teams.Conclusion: This study confirmed that even though all registered trials had the involvement of Portuguese institutions as a recruiting center, not all the published trials had Portuguese investigators as authors, mainly those initiated by the industry.
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spelling Portuguese Authorship in Published Clinical Trials: Differences in Industry and Investigator Initiated TrialsAutoria Portuguesa dos Ensaios Clínicos Publicados: Diferenças entre Ensaios Clínicos Iniciados pela Indústria e por InvestigadoresAuthorshipClinical Trials as TopicPortugalPublishingAutoriaEnsaios Clínicos como AssuntoPortugalPublicaçãoIntroduction: The aim of this study was to investigate the Portuguese authorship in publications resulting from trials initiated by the industry or investigators and run in Portugal.Material and Methods: Clinical trials with Portuguese institutions as sponsor or recruiting centers, and registered in four clinical trial registries, in the last 14 years, were assessed. Publications of completed trials, from both the initiative of the industry and investigatorswere screened and compared.Results: The percentage of published trials initiated by industry and investigators was similar (28.0%). However, the percentage of completed investigator-initiated trials (43.6%) was lower when compared to industry trials (69.7%). There was a higher percentage of Portuguese authorship in published investigator-initiated trials when compared with industry-initiated trials (47.1% vs 8.5%, respectively). Moreover, industry-initiated trials with Portuguese authors were published in journals with lower journal impact factor when compared with those published without authorship of Portuguese investigators. Oncology was the therapeutic area with the highest number of clinical trial registrations and publications. However, in publications with Portuguese authors, industry Initiated trials mainly focused on neurology while investigator-initiated trials had a higher number of papers in the fields of gastroenterology and infection diseases. Published trials with Portuguese authorship, initiated by the industry or investigators, also targeted different populations and had different purposes. In both cases, no significant differences were observed in terms of the journal impact factor or in the alignment of the published randomized trials with the respective reporting guidelines.Discussion: When compared with previous publications, this study showed an increasing trend in the number of clinical trials in Portugal, published within similar timeframes, after trial conclusion. Even though both industry and investigator trials are published within the standards for reporting trials, the low number of Portuguese authorships in industry publications might underline the need for invigorating these independent clinical trials in Portugal by capacitating and empowering national clinical research teams.Conclusion: This study confirmed that even though all registered trials had the involvement of Portuguese institutions as a recruiting center, not all the published trials had Portuguese investigators as authors, mainly those initiated by the industry.Introdução: Este estudo teve por objetivo investigar a autoria Portuguesa em publicações que resultem de ensaios clínicos iniciados pela indústria e por investigadores, que tenham decorrido em Portugal.Material e Métodos: Quatro plataformas de registo de ensaios clínicos foram utilizadas para encontrar ensaios clínicos tendo instituições Portuguesas como promotor ou centro de recrutamento nos últimos 14 anos. Foram analisadas e comparadas as publicações dos estudos completos, da iniciativa da indústria e de investigadoresResultados: A percentagem de ensaios da iniciativa da indústria e de investigadores que são publicados era semelhante (~ 28,0%). Porém, a percentagem de ensaios completos da iniciativa de investigadores era mais baixa (43,6%) quando comparada com os ensaios completos da indústria (69,7%). Existiu uma maior percentagem de autores portugueses em ensaios publicados da iniciativa do investigador quando comparado com os ensaios da iniciativa da indústria (47,1% vs 8,5%). Para além disso, ensaios da iniciativa da indústria com autores portugueses foram publicados em jornais com fatores de impacto inferiores quando comparados com aqueles publicados sem autores portugueses. A oncologia foi a área terapêutica com maior número de ensaios registados e publicados. No entanto, em publicações com autores Portugueses, a indústria focou-se sobretudo na neurologia e os investigadores em gastroenterologia e doenças infeciosas. Ensaios publicados com autores portugueses, iniciados tanto pela indústria como por investigadores, focaram-se em populações diferentes e têm propósitos diferentes. Em ambos os casos, não foram encontradas diferenças estatisticamente significativas no fator de impacto dos jornais, nem no alinhamento dos ensaios aleatorizados publicados com as normas sobre escrita de artigos científicos.Discussão: Quando comparado com publicações anteriores, este estudo mostrou uma tendência de crescimento no número de ensaios clínicos em Portugal, sendo publicados em intervalos de tempo semelhantes após a sua conclusão. Embora os ensaios publicados da iniciativa da indústria e de investigadores estejam alinhados com as normas sobre escrita de artigos científicos, o baixo número de autorias nacionais em publicações de ensaios da indústria, sublinha a necessidade de revigorar os ensaios clínicos da iniciativa de investigadores através da capacitação e emancipação das equipas de investigação nacionais.Conclusão: Apesar de todos os ensaios registados terem o envolvimento de instituições portuguesas como centros de recrutamento, nem todos os ensaios têm autores portugueses nas publicações, principalmente aqueles que são iniciados pela indústria.Ordem dos Médicos2021-11-02info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfapplication/pdfapplication/pdfhttps://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/14554oai:ojs.www.actamedicaportuguesa.com:article/14554Acta Médica Portuguesa; Vol. 34 No. 11 (2021): November; 733-740Acta Médica Portuguesa; Vol. 34 N.º 11 (2021): Novembro; 733-7401646-07580870-399Xreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAPenghttps://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/14554https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/14554/6459https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/14554/6460https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/14554/6461Direitos de Autor (c) 2021 Acta Médica Portuguesainfo:eu-repo/semantics/openAccessPinheiro Andrade, MariaMatias, DanielaBatuca, JoanaGouveia, NéliaMota-Filipe, HélderCarreira Monteiro, EmíliaMadeira, Catarina2022-12-20T11:07:15Zoai:ojs.www.actamedicaportuguesa.com:article/14554Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T16:20:29.376432Repositório 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 Portuguese Authorship in Published Clinical Trials: Differences in Industry and Investigator Initiated Trials
Autoria Portuguesa dos Ensaios Clínicos Publicados: Diferenças entre Ensaios Clínicos Iniciados pela Indústria e por Investigadores
title Portuguese Authorship in Published Clinical Trials: Differences in Industry and Investigator Initiated Trials
spellingShingle Portuguese Authorship in Published Clinical Trials: Differences in Industry and Investigator Initiated Trials
Pinheiro Andrade, Maria
Authorship
Clinical Trials as Topic
Portugal
Publishing
Autoria
Ensaios Clínicos como Assunto
Portugal
Publicação
title_short Portuguese Authorship in Published Clinical Trials: Differences in Industry and Investigator Initiated Trials
title_full Portuguese Authorship in Published Clinical Trials: Differences in Industry and Investigator Initiated Trials
title_fullStr Portuguese Authorship in Published Clinical Trials: Differences in Industry and Investigator Initiated Trials
title_full_unstemmed Portuguese Authorship in Published Clinical Trials: Differences in Industry and Investigator Initiated Trials
title_sort Portuguese Authorship in Published Clinical Trials: Differences in Industry and Investigator Initiated Trials
author Pinheiro Andrade, Maria
author_facet Pinheiro Andrade, Maria
Matias, Daniela
Batuca, Joana
Gouveia, Nélia
Mota-Filipe, Hélder
Carreira Monteiro, Emília
Madeira, Catarina
author_role author
author2 Matias, Daniela
Batuca, Joana
Gouveia, Nélia
Mota-Filipe, Hélder
Carreira Monteiro, Emília
Madeira, Catarina
author2_role author
author
author
author
author
author
dc.contributor.author.fl_str_mv Pinheiro Andrade, Maria
Matias, Daniela
Batuca, Joana
Gouveia, Nélia
Mota-Filipe, Hélder
Carreira Monteiro, Emília
Madeira, Catarina
dc.subject.por.fl_str_mv Authorship
Clinical Trials as Topic
Portugal
Publishing
Autoria
Ensaios Clínicos como Assunto
Portugal
Publicação
topic Authorship
Clinical Trials as Topic
Portugal
Publishing
Autoria
Ensaios Clínicos como Assunto
Portugal
Publicação
description Introduction: The aim of this study was to investigate the Portuguese authorship in publications resulting from trials initiated by the industry or investigators and run in Portugal.Material and Methods: Clinical trials with Portuguese institutions as sponsor or recruiting centers, and registered in four clinical trial registries, in the last 14 years, were assessed. Publications of completed trials, from both the initiative of the industry and investigatorswere screened and compared.Results: The percentage of published trials initiated by industry and investigators was similar (28.0%). However, the percentage of completed investigator-initiated trials (43.6%) was lower when compared to industry trials (69.7%). There was a higher percentage of Portuguese authorship in published investigator-initiated trials when compared with industry-initiated trials (47.1% vs 8.5%, respectively). Moreover, industry-initiated trials with Portuguese authors were published in journals with lower journal impact factor when compared with those published without authorship of Portuguese investigators. Oncology was the therapeutic area with the highest number of clinical trial registrations and publications. However, in publications with Portuguese authors, industry Initiated trials mainly focused on neurology while investigator-initiated trials had a higher number of papers in the fields of gastroenterology and infection diseases. Published trials with Portuguese authorship, initiated by the industry or investigators, also targeted different populations and had different purposes. In both cases, no significant differences were observed in terms of the journal impact factor or in the alignment of the published randomized trials with the respective reporting guidelines.Discussion: When compared with previous publications, this study showed an increasing trend in the number of clinical trials in Portugal, published within similar timeframes, after trial conclusion. Even though both industry and investigator trials are published within the standards for reporting trials, the low number of Portuguese authorships in industry publications might underline the need for invigorating these independent clinical trials in Portugal by capacitating and empowering national clinical research teams.Conclusion: This study confirmed that even though all registered trials had the involvement of Portuguese institutions as a recruiting center, not all the published trials had Portuguese investigators as authors, mainly those initiated by the industry.
publishDate 2021
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dc.publisher.none.fl_str_mv Ordem dos Médicos
publisher.none.fl_str_mv Ordem dos Médicos
dc.source.none.fl_str_mv Acta Médica Portuguesa; Vol. 34 No. 11 (2021): November; 733-740
Acta Médica Portuguesa; Vol. 34 N.º 11 (2021): Novembro; 733-740
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