Sponsored multicentric clinical research conducted in Brazil in the respiratory area - losses and gains

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dc.citation.issue2
dc.citation.volume62
dc.contributor.authorda Silveira Carvalho, Andrea Kelly
dc.contributor.authorNascimento, Oliver Augusto
dc.contributor.authorMachado Fonseca, Marcelo Cunio [UNIFESP]
dc.contributor.authorBarros Pereira, Eanes Delgado
dc.contributor.authorJardim, Jose Roberto [UNIFESP]
dc.coverageSao Paulo
dc.date.accessioned2020-08-21T16:59:58Z
dc.date.available2020-08-21T16:59:58Z
dc.date.issued2016
dc.description.abstractObjective: To evaluate the sponsored centers for clinical trial in the respiratory care setting in Brazil: profile; logistics and structure. Methods: Principal investigators (29) and subinvestigators (30) of 39 research centers completed the questionnaires that addressed personal identification and training of researchers, the centers' facilities and advantages and/or disadvantages of performing sponsored trials. Results: 75.6% of the centers were located in southern and southeastern Brazil. Most principal investigators were men with a mean age of 53.4 years. The clinical trials in the respiratory care setting focus on asthma and chronic obstructive pulmonary disease (COPD). 80% of the researchers cited delay of the Conep and Anvisa as a barrier to performing research. The advantages of participating in clinical trials were updating knowledge of the researcher and the team, and additional income for the team. The main disadvantages mentioned by the researchers included low financial compensation for the performed workload, and time availability. The median number of professionals per research center was six people, predominantly physicians. Conclusion: The number of research centers in the respiratory care setting in Brazil is still relatively small. The teams have good training for performing the clinical trials. Asthma and COPD are the most studied diseases in sponsored clinical trials. The main barrier is delay by the Conep and Anvisa. The factors that lead investigators to participate range from being updated along with the team, to site and staff financial issues; the main disadvantage is the low compensation for the required workload demand.en
dc.description.affiliationUniv Fortaleza Unifor, Grad Program Cardioresp Physiotherapy, Fortaleza, CE, Brazil
dc.description.affiliationXlung Pulmoctr, Fortaleza, CE, Brazil
dc.description.affiliationUniv Fed Sao Paulo, Pulm Rehabil Ctr, Sao Paulo, SP, Brazil
dc.description.affiliationUniv Fed Sao Paulo, Dept Gynecol, Womens Hlth Area, Technol Assessment Serv, Sao Paulo, SP, Brazil
dc.description.affiliationUniv Fed Ceara, Dept Internal Med, Fortaleza, CE, Brazil
dc.description.affiliationUniv Fed Sao Paulo, Pneumol, Escola Paulista Med, Sao Paulo, SP, Brazil
dc.description.affiliationUnifespUniv Fed Sao Paulo, Pulm Rehabil Ctr, Sao Paulo, SP, Brazil
dc.description.affiliationUnifespUniv Fed Sao Paulo, Dept Gynecol, Womens Hlth Area, Technol Assessment Serv, Sao Paulo, SP, Brazi
dc.description.affiliationUnifespUniv Fed Sao Paulo, Pneumol, Escola Paulista Med, Sao Paulo, SP, Brazil
dc.description.sourceWeb of Science
dc.format.extent131-137
dc.identifierhttp://dx.doi.org/10.1590/1806-9282.62.02.131
dc.identifier.citationRevista Da Associacao Medica Brasileira. Sao Paulo, v. 62, n. 2, p. 131-137, 2016.
dc.identifier.doi10.1590/1806-9282.62.02.131
dc.identifier.fileS0104-42302016000200131-en.pdf
dc.identifier.issn0104-4230
dc.identifier.scieloS0104-42302016000200131
dc.identifier.urihttps://repositorio.unifesp.br/handle/11600/57816
dc.identifier.wosWOS:000378266400006
dc.language.isoeng
dc.publisherAssoc Medica Brasileira
dc.relation.ispartofRevista Da Associacao Medica Brasileira
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectBiomedical researchen
dc.subjectdrug industryen
dc.subjectclinical trials as topicen
dc.titleSponsored multicentric clinical research conducted in Brazil in the respiratory area - losses and gainsen
dc.typeinfo:eu-repo/semantics/article
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