Comment garantir des données médicales de qualité dans les études cliniques, pharmaco-épidémiologiques et en pharmacovigilance ?
Identifieur interne : 001444 ( Main/Exploration ); précédent : 001443; suivant : 001445Comment garantir des données médicales de qualité dans les études cliniques, pharmaco-épidémiologiques et en pharmacovigilance ?
Auteurs : François Alla [France] ; Myriam Rosilio [France] ; Christian Funck-Brentano [France] ; Philippe Barthélémy [France] ; Sophie Brisset [France] ; Dominic Cellier [France] ; Olivier Chassany [France] ; Jean-Paul Demarez [France] ; Vincent Diebolt [France] ; Alain Francillon [France] ; Laetitia Gambotti [France] ; Hakima Hannachi [France] ; Philippe Lechat [France] ; François Lemaire [France] ; Michel Lièvre [France] ; Christophe Misse [France] ; Marina Nguon [France] ; Antoine Pariente [France] ; Michel Rosenheim [France] ; Nadine Weisslinger-Darmon [France]Source :
- Thérapie [ 0040-5957 ] ; 2013-08-28.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme, Médicament, Recommandation, Santé publique.
English descriptors
- KwdEn :
Abstract
Le développement des médicaments fait l’objet de normes de qualité qui visent à garantir que le contenu d’une base de données soit un reflet fidèle du dossier source. Paradoxalement, ces normes abordent peu la qualité de la donnée source elle-même. L’objectif de ce travail était de proposer des recommandations pour améliorer la qualité des données dans trois champs (études cliniques, pharmaco-épidémiologiques et de pharmacovigilance). L’analyse s’est centrée sur les données et les étapes critiques, qui posent un problème important de qualité et pour lesquelles les recommandations actuelles ne sont pas suffisamment détaillées, peu adaptées et/ou appliquées. Au final, des recommandations ont été formulées qui portent principalement sur la genèse de la donnée et sa transcription.
Url:
DOI: 10.2515/therapie/2013035
Affiliations:
- France
- Aquitaine, Auvergne-Rhône-Alpes, Grand Est, Lorraine (région), Midi-Pyrénées, Nouvelle-Aquitaine, Occitanie (région administrative), Rhône-Alpes, Île-de-France
- Bordeaux, Castres, Lyon, Nancy, Paris, Toulouse
- Université Pierre-et-Marie-Curie, Université de Lorraine
Links toward previous steps (curation, corpus...)
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- to stream Main, to step Merge: 001707
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Le document en format XML
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type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Weisslinger Darmon, Nadine" sort="Weisslinger Darmon, Nadine" uniqKey="Weisslinger Darmon N" first="Nadine" last="Weisslinger-Darmon">Nadine Weisslinger-Darmon</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Laboratoire GlaxoSmithKline, Marly-le-Roi</wicri:regionArea><wicri:noRegion>Marly-le-Roi</wicri:noRegion><wicri:noRegion>Marly-le-Roi</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Thérapie</title><title level="j" type="issue">XXVIIIes Rencontres Nationales de Pharmacologie et Recherche Clinique, Innovation et Évaluation des Technologies de Santé, Tables rondes GIENS – 7 au 9 octobre 2012</title><title level="j" type="abbrev">Therapie</title><title level="j" type="publisher-id">therapie</title><idno type="ISSN">0040-5957</idno><idno type="eISSN">1958-5578</idno><imprint><publisher>EDP Sciences</publisher><date type="Final-Published" when="2013-08-28">2013-08-28</date><date type="ePublished" when="2013-08-28">2013-08-28</date><date type="Published" when="2013-07">2013-07</date><biblScope unit="vol">68</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="209">209</biblScope><biblScope unit="page" to="216">216</biblScope><biblScope unit="page-count">8</biblScope><biblScope unit="ref-count">21</biblScope></imprint><idno type="ISSN">0040-5957</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0040-5957</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical trial</term><term>Data processing</term><term>Drug</term><term>Epidemiology</term><term>Human</term><term>Pharmacovigilance</term><term>Public health</term><term>Quality</term><term>Recommendation</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Epidémiologie</term><term>Essai clinique</term><term>Homme</term><term>Médicament</term><term>Pharmacovigilance</term><term>Pharmacoépidémiologie</term><term>Qualité</term><term>Recommandation</term><term>Santé publique</term><term>Traitement donnée</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term><term>Médicament</term><term>Recommandation</term><term>Santé publique</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="fr">Le développement des médicaments fait l’objet de normes de qualité qui visent à garantir que le contenu d’une base de données soit un reflet fidèle du dossier source. Paradoxalement, ces normes abordent peu la qualité de la donnée source elle-même. L’objectif de ce travail était de proposer des recommandations pour améliorer la qualité des données dans trois champs (études cliniques, pharmaco-épidémiologiques et de pharmacovigilance). L’analyse s’est centrée sur les données et les étapes critiques, qui posent un problème important de qualité et pour lesquelles les recommandations actuelles ne sont pas suffisamment détaillées, peu adaptées et/ou appliquées. Au final, des recommandations ont été formulées qui portent principalement sur la genèse de la donnée et sa transcription.</div></front></TEI><affiliations><list><country><li>France</li></country><region><li>Aquitaine</li><li>Auvergne-Rhône-Alpes</li><li>Grand Est</li><li>Lorraine (région)</li><li>Midi-Pyrénées</li><li>Nouvelle-Aquitaine</li><li>Occitanie (région administrative)</li><li>Rhône-Alpes</li><li>Île-de-France</li></region><settlement><li>Bordeaux</li><li>Castres</li><li>Lyon</li><li>Nancy</li><li>Paris</li><li>Toulouse</li></settlement><orgName><li>Université Pierre-et-Marie-Curie</li><li>Université de Lorraine</li></orgName></list><tree><country name="France"><region name="Grand Est"><name sortKey="Alla, Francois" sort="Alla, Francois" uniqKey="Alla F" first="François" last="Alla">François Alla</name></region><name sortKey="Alla, Francois" sort="Alla, Francois" uniqKey="Alla F" first="François" last="Alla">François Alla</name><name sortKey="Barthelemy, Philippe" sort="Barthelemy, Philippe" uniqKey="Barthelemy P" first="Philippe" last="Barthélémy">Philippe Barthélémy</name><name sortKey="Brisset, Sophie" sort="Brisset, Sophie" uniqKey="Brisset S" first="Sophie" last="Brisset">Sophie Brisset</name><name sortKey="Cellier, Dominic" sort="Cellier, Dominic" uniqKey="Cellier D" first="Dominic" last="Cellier">Dominic Cellier</name><name sortKey="Chassany, Olivier" sort="Chassany, Olivier" uniqKey="Chassany O" first="Olivier" last="Chassany">Olivier Chassany</name><name sortKey="Demarez, Jean Paul" sort="Demarez, Jean Paul" uniqKey="Demarez J" first="Jean-Paul" last="Demarez">Jean-Paul Demarez</name><name sortKey="Diebolt, Vincent" sort="Diebolt, Vincent" uniqKey="Diebolt V" first="Vincent" last="Diebolt">Vincent Diebolt</name><name sortKey="Francillon, Alain" sort="Francillon, Alain" uniqKey="Francillon A" first="Alain" last="Francillon">Alain Francillon</name><name sortKey="Funck Brentano, Christian" sort="Funck Brentano, Christian" uniqKey="Funck Brentano C" first="Christian" last="Funck-Brentano">Christian Funck-Brentano</name><name sortKey="Gambotti, Laetitia" sort="Gambotti, Laetitia" uniqKey="Gambotti L" first="Laetitia" last="Gambotti">Laetitia Gambotti</name><name sortKey="Hannachi, Hakima" sort="Hannachi, Hakima" uniqKey="Hannachi H" first="Hakima" last="Hannachi">Hakima Hannachi</name><name sortKey="Lechat, Philippe" sort="Lechat, Philippe" uniqKey="Lechat P" first="Philippe" last="Lechat">Philippe Lechat</name><name sortKey="Lemaire, Francois" sort="Lemaire, Francois" uniqKey="Lemaire F" first="François" last="Lemaire">François Lemaire</name><name sortKey="Lievre, Michel" sort="Lievre, Michel" uniqKey="Lievre M" first="Michel" last="Lièvre">Michel Lièvre</name><name sortKey="Misse, Christophe" sort="Misse, Christophe" uniqKey="Misse C" first="Christophe" last="Misse">Christophe Misse</name><name sortKey="Nguon, Marina" sort="Nguon, Marina" uniqKey="Nguon M" first="Marina" last="Nguon">Marina Nguon</name><name sortKey="Pariente, Antoine" sort="Pariente, Antoine" uniqKey="Pariente A" first="Antoine" last="Pariente">Antoine Pariente</name><name sortKey="Rosenheim, Michel" sort="Rosenheim, Michel" uniqKey="Rosenheim M" first="Michel" last="Rosenheim">Michel Rosenheim</name><name sortKey="Rosilio, Myriam" sort="Rosilio, Myriam" uniqKey="Rosilio M" first="Myriam" last="Rosilio">Myriam Rosilio</name><name sortKey="Weisslinger Darmon, Nadine" sort="Weisslinger Darmon, Nadine" uniqKey="Weisslinger Darmon N" first="Nadine" last="Weisslinger-Darmon">Nadine Weisslinger-Darmon</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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