Investigator Initiated Clinical Trials (IICTs)

Detalhes bibliográficos
Autor(a) principal: Madeira, C.
Data de Publicação: 2021
Outros Autores: Hořavová, L., dos Santos, F., Batuca, J. R., Nebeska, K., Součková, L., Kubiak, C., Demotes, J., Demlová, R., Monteiro, E. C.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10362/119497
Resumo: Funding: In the Czech Republic, this work was supported by the European Regional Development Fund - Project CZECRIN_4 PACIENTY (No. CZ.02.1.01/0.0/0.0/16_013/0001826) and Large Research infrastructure CZECRIN – LM2015090. CM and FS were supported by Fundação para a Ciência e a Tecnologia (FCT, through the membership fees to ECRIN-ERIC published at Portaria nº 237/2014). The funders did not interfere with the design of the study, collection, analysis and interpretation of data as well as with the writing of the manuscript.
id RCAP_24e677a1d8c0905678484eed4ddad57b
oai_identifier_str oai:run.unl.pt:10362/119497
network_acronym_str RCAP
network_name_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository_id_str 7160
spelling Investigator Initiated Clinical Trials (IICTs)A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific OutcomesClinical researchClinical research outcomeClinical trialClinical trials registryFundingInvestigator initiated clinical trialsPharmacology, Toxicology and Pharmaceutics (miscellaneous)Public Health, Environmental and Occupational HealthPharmacology (medical)SDG 3 - Good Health and Well-beingFunding: In the Czech Republic, this work was supported by the European Regional Development Fund - Project CZECRIN_4 PACIENTY (No. CZ.02.1.01/0.0/0.0/16_013/0001826) and Large Research infrastructure CZECRIN – LM2015090. CM and FS were supported by Fundação para a Ciência e a Tecnologia (FCT, through the membership fees to ECRIN-ERIC published at Portaria nº 237/2014). The funders did not interfere with the design of the study, collection, analysis and interpretation of data as well as with the writing of the manuscript.Objectives: Clinical trials provide one of the highest levels of evidence to support medical practice. Investigator initiated clinical trials (IICTs) answer relevant questions in clinical practice that may not be addressed by industry. For the first time, two European Countries are compared in terms of IICTs, respective funders and publications, envisaging to inspire others to use similar indicators to assess clinical research outcomes. Methods: A retrospective systematic search of registered IICTs from 2004 to 2017, using four clinical trials registries was carried out in two European countries with similar population, GDP, HDI and medical schools but with different governmental models to fund clinical research. Each IICT was screened for sponsors, funders, type of intervention and associated publications, once completed. Results: IICTs involving the Czech Republic and Portugal were n = 439 (42% with hospitals as sponsors) and n = 328 (47% with universities as sponsors), respectively. The Czech Republic and Portuguese funding agencies supported respectively 61 and 27 IICTs. Among these, trials with medicinal products represent 52% in Czech Republic and 4% in Portugal. In the first, a higher percentage of IICTs’ publications in high impact factor journals with national investigators as authors was observed, when compared to Portugal (75% vs 15%). Conclusion: The better performance in clinical research by Czech Republic might be related to the existence of specific and periodic funding for clinical research, although further data are still needed to confirm this relationship. In upcoming years, the indicators used herein might be useful to tracking clinical research outcomes in these and other European countries.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)Comprehensive Health Research Centre (CHRC) - pólo NMSRUNMadeira, C.Hořavová, L.dos Santos, F.Batuca, J. R.Nebeska, K.Součková, L.Kubiak, C.Demotes, J.Demlová, R.Monteiro, E. C.2021-06-17T22:20:15Z2021-092021-09-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10362/119497eng2168-4790PURE: 32023561https://doi.org/10.1007/s43441-021-00293-winfo: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:RCAAP2024-03-11T05:02:04Zoai:run.unl.pt:10362/119497Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:44:06.224668Repositório 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 Investigator Initiated Clinical Trials (IICTs)
A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes
title Investigator Initiated Clinical Trials (IICTs)
spellingShingle Investigator Initiated Clinical Trials (IICTs)
Madeira, C.
Clinical research
Clinical research outcome
Clinical trial
Clinical trials registry
Funding
Investigator initiated clinical trials
Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Public Health, Environmental and Occupational Health
Pharmacology (medical)
SDG 3 - Good Health and Well-being
title_short Investigator Initiated Clinical Trials (IICTs)
title_full Investigator Initiated Clinical Trials (IICTs)
title_fullStr Investigator Initiated Clinical Trials (IICTs)
title_full_unstemmed Investigator Initiated Clinical Trials (IICTs)
title_sort Investigator Initiated Clinical Trials (IICTs)
author Madeira, C.
author_facet Madeira, C.
Hořavová, L.
dos Santos, F.
Batuca, J. R.
Nebeska, K.
Součková, L.
Kubiak, C.
Demotes, J.
Demlová, R.
Monteiro, E. C.
author_role author
author2 Hořavová, L.
dos Santos, F.
Batuca, J. R.
Nebeska, K.
Součková, L.
Kubiak, C.
Demotes, J.
Demlová, R.
Monteiro, E. C.
author2_role author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
Comprehensive Health Research Centre (CHRC) - pólo NMS
RUN
dc.contributor.author.fl_str_mv Madeira, C.
Hořavová, L.
dos Santos, F.
Batuca, J. R.
Nebeska, K.
Součková, L.
Kubiak, C.
Demotes, J.
Demlová, R.
Monteiro, E. C.
dc.subject.por.fl_str_mv Clinical research
Clinical research outcome
Clinical trial
Clinical trials registry
Funding
Investigator initiated clinical trials
Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Public Health, Environmental and Occupational Health
Pharmacology (medical)
SDG 3 - Good Health and Well-being
topic Clinical research
Clinical research outcome
Clinical trial
Clinical trials registry
Funding
Investigator initiated clinical trials
Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Public Health, Environmental and Occupational Health
Pharmacology (medical)
SDG 3 - Good Health and Well-being
description Funding: In the Czech Republic, this work was supported by the European Regional Development Fund - Project CZECRIN_4 PACIENTY (No. CZ.02.1.01/0.0/0.0/16_013/0001826) and Large Research infrastructure CZECRIN – LM2015090. CM and FS were supported by Fundação para a Ciência e a Tecnologia (FCT, through the membership fees to ECRIN-ERIC published at Portaria nº 237/2014). The funders did not interfere with the design of the study, collection, analysis and interpretation of data as well as with the writing of the manuscript.
publishDate 2021
dc.date.none.fl_str_mv 2021-06-17T22:20:15Z
2021-09
2021-09-01T00:00:00Z
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 http://hdl.handle.net/10362/119497
url http://hdl.handle.net/10362/119497
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 2168-4790
PURE: 32023561
https://doi.org/10.1007/s43441-021-00293-w
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.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
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
institution RCAAP
reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
repository.mail.fl_str_mv
_version_ 1799138049146224640