Risk Management in Clinical Trials

Detalhes bibliográficos
Autor(a) principal: Vale, Margarida
Data de Publicação: 2023
Outros Autores: Leite, Francisca, Madeira, Catarina
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10362/160766
Resumo: Funding Information: The authors would like to acknowledge PtCRIN and all participating healthcare institutions for their availability to answer the survey and contribute to this research. CM acknowledges funding support from Portuguese public funding through Investimento RE-C05-i02 – Missão Interface N.° 01/C05-i02/2022 Publisher Copyright: © 2023 Vale et al.
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spelling Risk Management in Clinical TrialsAssessment of Current Practices at Portuguese Clinical Trial Sitesclinical researchhealthcareoperational risksplanningrisk assessment tooltrial feasibilityHealth PolicyPublic Health, Environmental and Occupational HealthSDG 3 - Good Health and Well-beingFunding Information: The authors would like to acknowledge PtCRIN and all participating healthcare institutions for their availability to answer the survey and contribute to this research. CM acknowledges funding support from Portuguese public funding through Investimento RE-C05-i02 – Missão Interface N.° 01/C05-i02/2022 Publisher Copyright: © 2023 Vale et al.Purpose: Over the last years, in response to the increasing complexity and demand of clinical trials, there has been a growing concern with the application of efficient risk management methodologies. The main objective of this work is to assess the current level of implementation of risk management activities by clinical trials sites’ teams and identify points of improvement. Methods: A cross-sectional study was conducted through an original, non-validated questionnaire created to assess the risk management practices at Portuguese clinical trial sites. The web-based survey was sent by e-mail to the clinical trial sites identified, and it was available for one month. Descriptive statistics were used to summarize the findings. Results: In total, 46 clinical trial sites accepted to participate in this study. The surveys’ answers showed that although 57.0% of sites reported the use of a systematic risk management tool, only nine sites (19.6%) described a standard tool or document that captured systematically the analysis of risks at the site level. Most of the sites (87.0%) showed willing to use a risk management tool specifically tailored for their operational needs, with the lack of knowledge about risk management being the main reason against its implementation. Conclusion: This work indicates that the surveyed clinical trial sites generally recognize the importance of risk management methodologies as an opportunity to anticipate difficulties in the trial conduct and optimize the use of sites’ resources. However, mainly due to lack of experience with risk management methodologies, sites are not currently implementing these strategies in the management of their trial-related operations. The development of a risk management tool for sites can be useful in this context.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)Comprehensive Health Research Centre (CHRC) - pólo NMSRUNVale, MargaridaLeite, FranciscaMadeira, Catarina2023-11-30T22:20:00Z2023-102023-10-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article10application/pdfhttp://hdl.handle.net/10362/160766eng1179-1594PURE: 75294347https://doi.org/10.2147/RMHP.S426411info: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:RCAAP2024-03-11T05:43:32Zoai:run.unl.pt:10362/160766Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:58:13.039797Repositório 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 Risk Management in Clinical Trials
Assessment of Current Practices at Portuguese Clinical Trial Sites
title Risk Management in Clinical Trials
spellingShingle Risk Management in Clinical Trials
Vale, Margarida
clinical research
healthcare
operational risks
planning
risk assessment tool
trial feasibility
Health Policy
Public Health, Environmental and Occupational Health
SDG 3 - Good Health and Well-being
title_short Risk Management in Clinical Trials
title_full Risk Management in Clinical Trials
title_fullStr Risk Management in Clinical Trials
title_full_unstemmed Risk Management in Clinical Trials
title_sort Risk Management in Clinical Trials
author Vale, Margarida
author_facet Vale, Margarida
Leite, Francisca
Madeira, Catarina
author_role author
author2 Leite, Francisca
Madeira, Catarina
author2_role 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 Vale, Margarida
Leite, Francisca
Madeira, Catarina
dc.subject.por.fl_str_mv clinical research
healthcare
operational risks
planning
risk assessment tool
trial feasibility
Health Policy
Public Health, Environmental and Occupational Health
SDG 3 - Good Health and Well-being
topic clinical research
healthcare
operational risks
planning
risk assessment tool
trial feasibility
Health Policy
Public Health, Environmental and Occupational Health
SDG 3 - Good Health and Well-being
description Funding Information: The authors would like to acknowledge PtCRIN and all participating healthcare institutions for their availability to answer the survey and contribute to this research. CM acknowledges funding support from Portuguese public funding through Investimento RE-C05-i02 – Missão Interface N.° 01/C05-i02/2022 Publisher Copyright: © 2023 Vale et al.
publishDate 2023
dc.date.none.fl_str_mv 2023-11-30T22:20:00Z
2023-10
2023-10-01T00:00:00Z
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/10362/160766
url http://hdl.handle.net/10362/160766
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 1179-1594
PURE: 75294347
https://doi.org/10.2147/RMHP.S426411
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 10
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
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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
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