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API Journal Authors: Flint Brenton, John Basso, Tim Hinds, Dan Sarel, John Esposito

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Utilisation du système SitePad® de PHT Corporation pour collecter les données électroniques concernant les comprimés d’OTEZLA (apremilast) récemment homologués de Celgene

Celgene Corporation a utilisé le système SitePad® de PHT Corporation afin de collecter les indicateurs de résultat primaires et secondaires pour les études portant sur son médicament Otezla (apremilast) qui a été homologué par la FDA en mars 2014 et qui vise à traiter les adultes atteints d’arthrite psoriasique (AP) active.

PHT est le principal fournisseur de technologies utilisées pour collecter les données électroniques enregistrées par les patients destinées à la recherche clinique. Le système SitePad de PHT inclut une tablette portable à grand écran permettant de capturer les évaluations des cliniciens et des patients, spécifiques à une étude, sur le site d’essai. Un accès en temps réel à toutes les données collectées est disponible dans StudyWorks™, le portail en ligne de PHT destiné à la consultation et à la gestion des données. L’utilisation du système SitePad aide à accroître la qualité des données collectées, le délai de blocage de la base de données et réduit les délais ainsi que les coûts de la surveillance.

L'innocuité et l'efficacité d’Otezla, un inhibiteur oral de la phosphodiestérase-4 (PDE-4), ont été évaluées dans le cadre de trois essais cliniques impliquant 1 493 patients souffrant d’AP active. Par rapport aux patients traités avec un placebo, ceux traités avec Otezla ont bénéficié d’une amélioration des signes et symptômes de l’AP, y compris au niveau des articulations douloureuses et tuméfiées et de la fonction physique.

Philip Lee, Président et PDG de PHT, a déclaré : « PHT est honorée d’avoir participé à ce programme de développement, qui a abouti à un succès pour Celgene et pour les patients souffrant d’AP à travers le monde. Les membres de l’équipe PHT qui ont travaillé sur ce projet sont satisfaits, tant personnellement que professionnellement, de participer à la mise sur le marché de cet important nouveau traitement. »

À propos de PHT Corporation

PHT Corporation est l'innovateur en clinique électronique qui promeut l'adoption des applications mobiles axées sur les patients pour améliorer la recherche clinique. Le système d'évaluation électronique des résultats cliniques de PHT recueille et établit des rapports sur les données sécurisées des patients en temps réel depuis les derniers modèles d'appareils mobiles. L'expertise scientifique, réglementaire et technologique de PHT, associée aux données de résultats de qualité, permet à ses clients de prendre en toute confiance des décisions par rapport à leurs recherches. Les commanditaires et sociétés de recherche sous contrat ont utilisé la suite logicielle PHT Patient Suite dans plus de 650 essais, qui ont débouché sur plus de 16 autorisations réglementaires. Visitez phtcorp.com pour plus d’informations au sujet de PHT. Suivez PHT sur LinkedIn, Twitter, Google+ et YouTube.

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