Transparency and accuracy in funding investigator-initiated clinical trials
Autor(a) principal: | |
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Data de Publicação: | 2019 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | https://doi.org/10.1136/bmjopen-2018-023394 |
Resumo: | Objectives This study aims to identify the sources of funding for investigator-initiated clinical trials (IICTs) in Portugal, and to recommend ways to improve the quality of information collected from clinical trial databases about funding. Design and methods A systematic search of trial registrations over the last 13 years - using the WHO International Clinical Trials Registry Platform (WHO-ICTRP) and four clinical trials registries (CTRs) - was carried out to identify IICTs in Portugal, used as a case study. Data from the databases were compared with data contained in publications to evaluate the consistency of information on funding sources. The term a € database' is used in this study to refer to both the WHO-ICTRP and the CTRs. When mentioned separately, the WHO-ICTRP is referred to as a a € platform', while the CTRs are referred to as a € registries'. Outcome Suggestions to improve clinical trials databases to clearly identify the funding sources and data ownership in IICTs. Results Two hundred and eighty-two IICTs were identified in Portugal. Twenty per cent of trials were supported by industry with unclear information on the ownership of the results. Inaccuracy was found in the information about sponsors and funders. The information about funding in all resulting publications (77 out of 133 completed studies) was also inconsistent between databases in 35 out of 77 (45%) of the studies. Notably, 23% of the trials funded by non-profit organisations (n=226) received funds from international and/or national funding agencies. Conclusions Identification of IICT funding and ownership of results is unclear in the databases used for this study, which may lead to misunderstandings about the independence of the obtained results. Transparency and accuracy are desirable so that public decision makers and strategic partners can accurately evaluate national performance in this particular type of clinical research. |
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Transparency and accuracy in funding investigator-initiated clinical trialsA systematic search in clinical trials databasesclinical trialsclinical trials databaseclinical trials registryinterventional clinical studiesinvestigator-initiated clinical trialsMedicine(all)Objectives This study aims to identify the sources of funding for investigator-initiated clinical trials (IICTs) in Portugal, and to recommend ways to improve the quality of information collected from clinical trial databases about funding. Design and methods A systematic search of trial registrations over the last 13 years - using the WHO International Clinical Trials Registry Platform (WHO-ICTRP) and four clinical trials registries (CTRs) - was carried out to identify IICTs in Portugal, used as a case study. Data from the databases were compared with data contained in publications to evaluate the consistency of information on funding sources. The term a € database' is used in this study to refer to both the WHO-ICTRP and the CTRs. When mentioned separately, the WHO-ICTRP is referred to as a a € platform', while the CTRs are referred to as a € registries'. Outcome Suggestions to improve clinical trials databases to clearly identify the funding sources and data ownership in IICTs. Results Two hundred and eighty-two IICTs were identified in Portugal. Twenty per cent of trials were supported by industry with unclear information on the ownership of the results. Inaccuracy was found in the information about sponsors and funders. The information about funding in all resulting publications (77 out of 133 completed studies) was also inconsistent between databases in 35 out of 77 (45%) of the studies. Notably, 23% of the trials funded by non-profit organisations (n=226) received funds from international and/or national funding agencies. Conclusions Identification of IICT funding and ownership of results is unclear in the databases used for this study, which may lead to misunderstandings about the independence of the obtained results. Transparency and accuracy are desirable so that public decision makers and strategic partners can accurately evaluate national performance in this particular type of clinical research.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)Centro de Estudos de Doenças Crónicas (CEDOC)RUNMadeira, CatarinaSantos, FranciscoKubiak, ChristineDemotes, JacquesMonteiro, Emília Carreira2019-05-30T22:19:58Z2019-05-012019-05-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttps://doi.org/10.1136/bmjopen-2018-023394eng2158-2440PURE: 13528035http://www.scopus.com/inward/record.url?scp=85065888043&partnerID=8YFLogxKhttps://doi.org/10.1136/bmjopen-2018-023394info: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:RCAAP2024-03-11T04:33:37Zoai:run.unl.pt:10362/71287Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:35:12.007878Repositório 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 |
Transparency and accuracy in funding investigator-initiated clinical trials A systematic search in clinical trials databases |
title |
Transparency and accuracy in funding investigator-initiated clinical trials |
spellingShingle |
Transparency and accuracy in funding investigator-initiated clinical trials Madeira, Catarina clinical trials clinical trials database clinical trials registry interventional clinical studies investigator-initiated clinical trials Medicine(all) |
title_short |
Transparency and accuracy in funding investigator-initiated clinical trials |
title_full |
Transparency and accuracy in funding investigator-initiated clinical trials |
title_fullStr |
Transparency and accuracy in funding investigator-initiated clinical trials |
title_full_unstemmed |
Transparency and accuracy in funding investigator-initiated clinical trials |
title_sort |
Transparency and accuracy in funding investigator-initiated clinical trials |
author |
Madeira, Catarina |
author_facet |
Madeira, Catarina Santos, Francisco Kubiak, Christine Demotes, Jacques Monteiro, Emília Carreira |
author_role |
author |
author2 |
Santos, Francisco Kubiak, Christine Demotes, Jacques Monteiro, Emília Carreira |
author2_role |
author author author author |
dc.contributor.none.fl_str_mv |
NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM) Centro de Estudos de Doenças Crónicas (CEDOC) RUN |
dc.contributor.author.fl_str_mv |
Madeira, Catarina Santos, Francisco Kubiak, Christine Demotes, Jacques Monteiro, Emília Carreira |
dc.subject.por.fl_str_mv |
clinical trials clinical trials database clinical trials registry interventional clinical studies investigator-initiated clinical trials Medicine(all) |
topic |
clinical trials clinical trials database clinical trials registry interventional clinical studies investigator-initiated clinical trials Medicine(all) |
description |
Objectives This study aims to identify the sources of funding for investigator-initiated clinical trials (IICTs) in Portugal, and to recommend ways to improve the quality of information collected from clinical trial databases about funding. Design and methods A systematic search of trial registrations over the last 13 years - using the WHO International Clinical Trials Registry Platform (WHO-ICTRP) and four clinical trials registries (CTRs) - was carried out to identify IICTs in Portugal, used as a case study. Data from the databases were compared with data contained in publications to evaluate the consistency of information on funding sources. The term a € database' is used in this study to refer to both the WHO-ICTRP and the CTRs. When mentioned separately, the WHO-ICTRP is referred to as a a € platform', while the CTRs are referred to as a € registries'. Outcome Suggestions to improve clinical trials databases to clearly identify the funding sources and data ownership in IICTs. Results Two hundred and eighty-two IICTs were identified in Portugal. Twenty per cent of trials were supported by industry with unclear information on the ownership of the results. Inaccuracy was found in the information about sponsors and funders. The information about funding in all resulting publications (77 out of 133 completed studies) was also inconsistent between databases in 35 out of 77 (45%) of the studies. Notably, 23% of the trials funded by non-profit organisations (n=226) received funds from international and/or national funding agencies. Conclusions Identification of IICT funding and ownership of results is unclear in the databases used for this study, which may lead to misunderstandings about the independence of the obtained results. Transparency and accuracy are desirable so that public decision makers and strategic partners can accurately evaluate national performance in this particular type of clinical research. |
publishDate |
2019 |
dc.date.none.fl_str_mv |
2019-05-30T22:19:58Z 2019-05-01 2019-05-01T00:00:00Z |
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 |
https://doi.org/10.1136/bmjopen-2018-023394 |
url |
https://doi.org/10.1136/bmjopen-2018-023394 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
2158-2440 PURE: 13528035 http://www.scopus.com/inward/record.url?scp=85065888043&partnerID=8YFLogxK https://doi.org/10.1136/bmjopen-2018-023394 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
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application/pdf |
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reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
institution |
RCAAP |
reponame_str |
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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