A Framework for Extension Studies Using Real-World Data to Examine Long-Term Safety and Effectiveness.

Burcu, Mehmet; Manzano-Salgado, Cyntia B; Butler, Anne M; Christian, Jennifer B

Burcu, Mehmet; Manzano-Salgado, Cyntia B; Butler, Anne M; Christian, Jennifer B.

Affiliation

Burcu M; Department of Epidemiology, Merck & Co., Inc., Kenilworth, NJ, USA.
Manzano-Salgado CB; Real-World Solutions, IQVIA, Durham, NC, USA.
Butler AM; Washington University in St. Louis, St. Louis, MO, USA.
Christian JB; Real-World Solutions, IQVIA, Durham, NC, USA. Jennifer.Christian@iqvia.com.

Ther Innov Regul Sci ; 56(1): 15-22, 2022 01.

Article de En | MEDLINE | ID: mdl-34251656

Sujet(s)
Mots clés

Direct-to-patient; Enriched studies; Extension studies; Long-term outcomes; Observational follow-up; Patient-mediated data; Pragmatic approaches; Real-world data; Real-world evidence; Roll-over studies

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Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Plan de recherche / Pharmacoépidémiologie Type d'étude: Guideline / Prognostic_studies Limites: Humans Langue: En Journal: Ther Innov Regul Sci Année: 2022 Type de document: Article Pays d'affiliation: États-Unis d'Amérique Pays de publication: Suisse

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