Diffusion a validation process : learning from patient innovators
Autor(a) principal: | |
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Data de Publicação: | 2013 |
Tipo de documento: | Dissertação |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10400.14/17590 |
Resumo: | Randomized, controlled clinical trials, although important for ensuring safety and efficacy, are criticized for being an inadequate validation process for certain medical innovation modalities and conditions. The main limitations and causes for critique are high costs, long duration, low patient recruitment, design rigidity and ethical issues. At the same time, there is growing evidence that patients and their family members innovate in treatments, therapies, and medical devices. These patient innovators are increasingly recognized as an important source of innovation. Although there is a fairly complex structure developed to formally validate healthcare products, little is known about the paths patient innovators take to validate their solutions before involving health regulators. In this context, we attempt to answer the following research questions: What are the patterns of the validation processes undertaken by patient innovators for their innovations? How can current practices of patient innovation validation be improved from its comparison with observational studies and clinical trials? To address these questions, we study cases of patient innovators who attempted to share their innovations with other patients. More specifically, we structure the observed processes of patient innovation diffusion as a process model for an iterative observational trial process in which incremental validation of the innovation is performed by diffusing it to other patients. We contrast this process with a general streamlined process of randomized clinical trials. We argue learning from the patient innovators practices is important for discussing viable frameworks and structures for improving the safety and efficacy of these processes. We discuss related implications to innovation research, management and policy. |
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Diffusion a validation process : learning from patient innovatorsUser innovationPatient innovationDiffusionValidation of health-care innovationsObservational trialsDomínio/Área Científica::Ciências Sociais::Economia e GestãoRandomized, controlled clinical trials, although important for ensuring safety and efficacy, are criticized for being an inadequate validation process for certain medical innovation modalities and conditions. The main limitations and causes for critique are high costs, long duration, low patient recruitment, design rigidity and ethical issues. At the same time, there is growing evidence that patients and their family members innovate in treatments, therapies, and medical devices. These patient innovators are increasingly recognized as an important source of innovation. Although there is a fairly complex structure developed to formally validate healthcare products, little is known about the paths patient innovators take to validate their solutions before involving health regulators. In this context, we attempt to answer the following research questions: What are the patterns of the validation processes undertaken by patient innovators for their innovations? How can current practices of patient innovation validation be improved from its comparison with observational studies and clinical trials? To address these questions, we study cases of patient innovators who attempted to share their innovations with other patients. More specifically, we structure the observed processes of patient innovation diffusion as a process model for an iterative observational trial process in which incremental validation of the innovation is performed by diffusing it to other patients. We contrast this process with a general streamlined process of randomized clinical trials. We argue learning from the patient innovators practices is important for discussing viable frameworks and structures for improving the safety and efficacy of these processes. We discuss related implications to innovation research, management and policy.Oliveira, PedroZejnilović, LeidVeritati - Repositório Institucional da Universidade Católica PortuguesaNogueira, Tomás Fidélis da Silva2015-05-13T14:00:46Z2013-11-0120132013-11-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisapplication/pdfhttp://hdl.handle.net/10400.14/17590TID:201181878enginfo: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:RCAAP2023-10-31T01:33:21Zoai:repositorio.ucp.pt:10400.14/17590Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T18:14:42.527417Repositório 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 |
Diffusion a validation process : learning from patient innovators |
title |
Diffusion a validation process : learning from patient innovators |
spellingShingle |
Diffusion a validation process : learning from patient innovators Nogueira, Tomás Fidélis da Silva User innovation Patient innovation Diffusion Validation of health-care innovations Observational trials Domínio/Área Científica::Ciências Sociais::Economia e Gestão |
title_short |
Diffusion a validation process : learning from patient innovators |
title_full |
Diffusion a validation process : learning from patient innovators |
title_fullStr |
Diffusion a validation process : learning from patient innovators |
title_full_unstemmed |
Diffusion a validation process : learning from patient innovators |
title_sort |
Diffusion a validation process : learning from patient innovators |
author |
Nogueira, Tomás Fidélis da Silva |
author_facet |
Nogueira, Tomás Fidélis da Silva |
author_role |
author |
dc.contributor.none.fl_str_mv |
Oliveira, Pedro Zejnilović, Leid Veritati - Repositório Institucional da Universidade Católica Portuguesa |
dc.contributor.author.fl_str_mv |
Nogueira, Tomás Fidélis da Silva |
dc.subject.por.fl_str_mv |
User innovation Patient innovation Diffusion Validation of health-care innovations Observational trials Domínio/Área Científica::Ciências Sociais::Economia e Gestão |
topic |
User innovation Patient innovation Diffusion Validation of health-care innovations Observational trials Domínio/Área Científica::Ciências Sociais::Economia e Gestão |
description |
Randomized, controlled clinical trials, although important for ensuring safety and efficacy, are criticized for being an inadequate validation process for certain medical innovation modalities and conditions. The main limitations and causes for critique are high costs, long duration, low patient recruitment, design rigidity and ethical issues. At the same time, there is growing evidence that patients and their family members innovate in treatments, therapies, and medical devices. These patient innovators are increasingly recognized as an important source of innovation. Although there is a fairly complex structure developed to formally validate healthcare products, little is known about the paths patient innovators take to validate their solutions before involving health regulators. In this context, we attempt to answer the following research questions: What are the patterns of the validation processes undertaken by patient innovators for their innovations? How can current practices of patient innovation validation be improved from its comparison with observational studies and clinical trials? To address these questions, we study cases of patient innovators who attempted to share their innovations with other patients. More specifically, we structure the observed processes of patient innovation diffusion as a process model for an iterative observational trial process in which incremental validation of the innovation is performed by diffusing it to other patients. We contrast this process with a general streamlined process of randomized clinical trials. We argue learning from the patient innovators practices is important for discussing viable frameworks and structures for improving the safety and efficacy of these processes. We discuss related implications to innovation research, management and policy. |
publishDate |
2013 |
dc.date.none.fl_str_mv |
2013-11-01 2013 2013-11-01T00:00:00Z 2015-05-13T14:00:46Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/masterThesis |
format |
masterThesis |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10400.14/17590 TID:201181878 |
url |
http://hdl.handle.net/10400.14/17590 |
identifier_str_mv |
TID:201181878 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
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info:eu-repo/semantics/openAccess |
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openAccess |
dc.format.none.fl_str_mv |
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 |
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RCAAP |
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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) |
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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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1799131825964056576 |