Provision of investigational drug after clinical research - Review of literature, national and international guidelines

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorDAINESI, Sonia Mansoldo
dc.contributor.authorGOLDBAUM, Moises
dc.date.accessioned2017-11-27T16:34:06Z
dc.date.available2017-11-27T16:34:06Z
dc.date.issued2011
dc.description.abstractProvision of investigational drug after clinical research - Review of literature, national and international guidelines The post-trial access to investigational drugs has been the object of discussion since the late 1980s at least, initially linked to trials carried out in acquired immunodeficiency syndrome and, particularly, in developing countries, where the concern with patient vulnerability is more important. National and international guidelines do mention the subject; however, the complexity of the issue is not easily addressed and usually requires additional and specific discussions. The decision on providing the investigational drug after the trial shall rest on at least two dimensions: efficacy and safety assessments, as the new drug is still on the experimental phase. Each clinical trial shall have its own assessment, taking into account the disease being studied, as well as the study population and their specific needs. Therefore, the nature of post-trial obligations cannot be considered the same in all situations and contexts; nevertheless, it should be assured that the relationship developed between investigators and patients during the study must be always terminated with respect and responsibility.
dc.description.indexMEDLINE
dc.identifier.citationREVISTA DA ASSOCIACAO MEDICA BRASILEIRA, v.57, n.6, p.710-716, 2011
dc.identifier.issn0104-4230
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/23370
dc.language.isopor
dc.publisherASSOC MEDICA BRASILEIRA
dc.relation.ispartofRevista da Associacao Medica Brasileira
dc.rightsopenAccess
dc.rights.holderCopyright ASSOC MEDICA BRASILEIRA
dc.subjectContinuity of patient care
dc.subjectdrugs, investigational
dc.subjectclinical research
dc.subjectbioethics
dc.subjectethics committees, research
dc.subjectvulnerability
dc.subject.otherdeveloping-countries
dc.subject.otherposttrial access
dc.subject.otherresearch participants
dc.subject.othertrials
dc.subject.otherinterventions
dc.subject.otherhiv/aids
dc.subject.otherethics
dc.subject.otherviews
dc.subject.othercare
dc.subject.wosMedicine, General & Internal
dc.titleProvision of investigational drug after clinical research - Review of literature, national and international guidelines
dc.typearticle
dc.type.categoryreview
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.contributor.author-fmusphcSONIA MANSOLDO DAINESI
hcfmusp.contributor.author-fmusphcMOISES GOLDBAUM
hcfmusp.description.beginpage710
hcfmusp.description.endpage716
hcfmusp.description.issue6
hcfmusp.description.volume57
hcfmusp.origemWOS
hcfmusp.origem.pubmed22249554
hcfmusp.origem.wosWOS:000298265100020
hcfmusp.publisher.citySAO PAULO
hcfmusp.publisher.countryBRAZIL
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relation.isAuthorOfPublication.latestForDiscoveryd28ae220-e924-459d-90e6-1cdcddb38877
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