Publicação
Transparency and accuracy in funding investigator-initiated clinical trials
| 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. |
|---|---|
| Autores principais: | Madeira, Catarina |
| Outros Autores: | Santos, Francisco; Kubiak, Christine; Demotes, Jacques; Monteiro, Emília Carreira; Monteiro, E.C. |
| Assunto: | clinical trials clinical trials database clinical trials registry interventional clinical studies investigator-initiated clinical trials General Medicine |
| Ano: | 2019 |
| País: | Portugal |
| Tipo de documento: | artigo |
| Tipo de acesso: | acesso aberto |
| Instituição associada: | Universidade Nova de Lisboa |
| Idioma: | inglês |
| Origem: | Repositório Institucional da UNL |
| _version_ | 1868414883689660416 |
|---|---|
| author | Madeira, Catarina |
| author2 | Santos, Francisco Kubiak, Christine Demotes, Jacques Monteiro, Emília Carreira Monteiro, E.C. |
| author2_role | author author author author author |
| author_facet | Madeira, Catarina Santos, Francisco Kubiak, Christine Demotes, Jacques Monteiro, Emília Carreira Monteiro, E.C. |
| author_role | author |
| contributor_name_str_mv | NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM) Centro de Estudos de Doenças Crónicas (CEDOC) BMJ Publishing Group RUN |
| country_str | PT |
| creators_json_txt | [{\"Person.name\":\"Madeira, Catarina\"},{\"Person.name\":\"Santos, Francisco\"},{\"Person.name\":\"Kubiak, Christine\"},{\"Person.name\":\"Demotes, Jacques\"},{\"Person.name\":\"Monteiro, Emília Carreira\"},{\"Person.name\":\"Monteiro, E.C.\",\"Person.identifier.orcid\":\"0000-0002-0570-0765\"}] |
| datacite.contributors.contributor.contributorName.fl_str_mv | NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM) Centro de Estudos de Doenças Crónicas (CEDOC) BMJ Publishing Group RUN |
| datacite.creators.creator.creatorName.fl_str_mv | Madeira, Catarina Santos, Francisco Kubiak, Christine Demotes, Jacques Monteiro, Emília Carreira Monteiro, E.C. |
| datacite.date.Accepted.fl_str_mv | 2019-05-01T00:00:00Z |
| datacite.date.available.fl_str_mv | 2019-05-30T22:19:58Z |
| datacite.date.embargoed.fl_str_mv | 2019-05-30T22:19:58Z |
| datacite.rights.fl_str_mv | http://purl.org/coar/access_right/c_abf2 |
| datacite.subjects.subject.fl_str_mv | clinical trials clinical trials database clinical trials registry interventional clinical studies investigator-initiated clinical trials General Medicine |
| datacite.titles.title.fl_str_mv | Transparency and accuracy in funding investigator-initiated clinical trials A systematic search in clinical trials databases |
| dc.contributor.none.fl_str_mv | NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM) Centro de Estudos de Doenças Crónicas (CEDOC) BMJ Publishing Group RUN |
| dc.creator.none.fl_str_mv | Madeira, Catarina Santos, Francisco Kubiak, Christine Demotes, Jacques Monteiro, Emília Carreira Monteiro, E.C. |
| dc.date.Accepted.fl_str_mv | 2019-05-01T00:00:00Z |
| dc.date.available.fl_str_mv | 2019-05-30T22:19:58Z |
| dc.date.embargoed.fl_str_mv | 2019-05-30T22:19:58Z |
| dc.format.none.fl_str_mv | application/pdf |
| dc.identifier.none.fl_str_mv | http://www.scopus.com/inward/record.url?scp=85065888043&partnerID=8YFLogxK |
| dc.language.none.fl_str_mv | eng |
| dc.rights.none.fl_str_mv | http://purl.org/coar/access_right/c_abf2 |
| dc.subject.none.fl_str_mv | clinical trials clinical trials database clinical trials registry interventional clinical studies investigator-initiated clinical trials General Medicine |
| dc.title.fl_str_mv | Transparency and accuracy in funding investigator-initiated clinical trials A systematic search in clinical trials databases |
| dc.type.none.fl_str_mv | http://purl.org/coar/resource_type/c_6501 |
| 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. |
| dirty | 0 |
| eu_rights_str_mv | openAccess |
| format | article |
| fulltext.url.fl_str_mv | https://run.unl.pt/bitstreams/ada6e8bb-957b-4c38-891c-e825d1e288bd/download |
| id | run_12df8bcf271affc76b63e85795fea7df |
| identifier.url.fl_str_mv | http://www.scopus.com/inward/record.url?scp=85065888043&partnerID=8YFLogxK |
| instacron_str | unl |
| institution | Universidade Nova de Lisboa |
| instname_str | Universidade Nova de Lisboa |
| language | eng |
| network_acronym_str | run |
| network_name_str | Repositório Institucional da UNL |
| oai_identifier_str | oai:run.unl.pt:10362/71287 |
| organization_str_mv | urn:organizationAcronym:unl |
| person_str_mv | Madeira, Catarina Santos, Francisco Kubiak, Christine Demotes, Jacques Monteiro, Emília Carreira Monteiro, E.C. Monteiro, E.C. https://www.ciencia-id.pt/5918-54A6-FAA0 5918-54A6-FAA0 http://orcid.org/0000-0002-0570-0765 0000-0002-0570-0765 |
| publishDate | 2019 |
| reponame_str | Repositório Institucional da UNL |
| repository_id_str | urn:repositoryAcronym:run |
| service_str_mv | urn:repositoryAcronym:run |
| spelling | engenObjectives 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.application/pdfenTransparency and accuracy in funding investigator-initiated clinical trialsSubtitleenA systematic search in clinical trials databasesMadeira, CatarinaSantos, FranciscoKubiak, ChristineDemotes, JacquesMonteiro, Emília CarreiraPersonalMonteiro, E.C.DSpacehttp://dspace.org/items/631292a4-58bc-4ec4-97ee-1143e44df2c0DSpacehttp://dspace.org/items/631292a4-58bc-4ec4-97ee-1143e44df2c0MonteiroEmília CarreiraCiência IDhttps://www.ciencia-id.pt5918-54A6-FAA0ORCIDhttp://orcid.org0000-0002-0570-0765Scopus Author IDhttps://www.scopus.com7102113853NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)Centro de Estudos de Doenças Crónicas (CEDOC)BMJ Publishing GroupHostingInstitutionOrganizationalRUNe-mailmailto:run@unl.ptrun@unl.ptISSNIsPartOf2158-2440URNIsPartOfPURE: 13528035URNIsPartOfPURE UUID: c58cadc8-223b-42c6-bfcc-0d02ac3775b7URNIsPartOfScopus: 85065888043URNIsPartOfPubMed: 31092640URNIsPartOfWOS: 000471192800034DOIIsPartOf10.1136/bmjopen-2018-0233942019-05-30T22:19:58Z2019-05-012019-05-01T00:00:00ZURLhttp://www.scopus.com/inward/record.url?scp=85065888043&partnerID=8YFLogxKhttp://purl.org/coar/access_right/c_abf2open accessclinical trialsclinical trials databaseclinical trials registryinterventional clinical studiesinvestigator-initiated clinical trialsGeneral Medicine2298914 bytesliteraturehttp://purl.org/coar/resource_type/c_6501journal articlehttp://purl.org/coar/access_right/c_abf2application/pdffulltexthttps://run.unl.pt/bitstreams/ada6e8bb-957b-4c38-891c-e825d1e288bd/download |
| 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 General Medicine |
| status | SINGLETON |
| subject.fl_str_mv | clinical trials clinical trials database clinical trials registry interventional clinical studies investigator-initiated clinical trials General Medicine |
| title | 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_short | Transparency and accuracy in funding investigator-initiated clinical trials |
| title_sort | Transparency and accuracy in funding investigator-initiated clinical trials |
| topic | clinical trials clinical trials database clinical trials registry interventional clinical studies investigator-initiated clinical trials General Medicine |
| topic_facet | clinical trials clinical trials database clinical trials registry interventional clinical studies investigator-initiated clinical trials General Medicine |
| url | http://www.scopus.com/inward/record.url?scp=85065888043&partnerID=8YFLogxK |
| visible | 1 |