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Diffusion a validation process : learning from patient innovators

datacite.subject.fosCiências Sociais::Economia e Gestão
dc.contributor.advisorOliveira, Pedro
dc.contributor.advisorZejnilović, Leid
dc.contributor.authorNogueira, Tomás Fidélis da Silva
dc.date.accessioned2015-05-13T14:00:46Z
dc.date.available2015-05-13T14:00:46Z
dc.date.issued2013-11-01
dc.date.submitted2013
dc.description.abstractRandomized, 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.por
dc.identifier.tid201181878
dc.identifier.urihttp://hdl.handle.net/10400.14/17590
dc.language.isoengpor
dc.subjectUser innovationpor
dc.subjectPatient innovationpor
dc.subjectDiffusionpor
dc.subjectValidation of health-care innovationspor
dc.subjectObservational trialspor
dc.titleDiffusion a validation process : learning from patient innovatorspor
dc.typemaster thesis
dspace.entity.typePublication
rcaap.rightsopenAccesspor
rcaap.typemasterThesispor
thesis.degree.nameMestrado em Gestão

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