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dc.contributor.authorBansal, Dipika
dc.contributor.authorBhagat, Anil
dc.contributor.authorSchifano, Fabrizio
dc.contributor.authorGudala, Kapil
dc.date.accessioned2020-03-04T01:11:21Z
dc.date.available2020-03-04T01:11:21Z
dc.date.issued2015-05-29
dc.identifier.citationBansal , D , Bhagat , A , Schifano , F & Gudala , K 2015 , ' Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008-2012) ' , Journal of Epidemiology and Global Health , vol. 5 , no. 4 , pp. 385-395 . https://doi.org/10.1016/j.jegh.2015.04.006
dc.identifier.issn2210-6006
dc.identifier.otherPURE: 19282509
dc.identifier.otherPURE UUID: 9a1d317b-e27a-4944-bf1b-4009fdfa28ec
dc.identifier.otherScopus: 84946495377
dc.identifier.otherPubMed: 26031612
dc.identifier.urihttp://hdl.handle.net/2299/22379
dc.description.abstractThe present study aimed at systematically reviewing the role and extent of patient-reported outcomes (PROs) usage within the package of scientific evidence considered for marketing authorization (MA). All regulatory information published by the European Medicines Agency (EMA) for products authorized between January 2008 and December 2012 and appearing in the European Public Assessment Report (EPAR) database was examined for efficacy endpoints. The endpoints here considered included: PROs, clinician reported outcomes (CROs), and laboratory reported outcomes (LROs). LROs were the most frequently reported endpoints. Out of the 180 products here selected, 99 (55%), 67 (37%), and 30 (17%), respectively, used LROs, CROs and PROs as primary endpoints (PEs). PROs as any endpoints were used in 82 (46%) products. Out of these, PROs were documented as PE in 30 (37%), with 27 (33%) products having used PROs both as primary and non-PEs. PRO usage was most frequently identified with nervous system and antineoplastic agents. During the study period, the use of all the three types of endpoints appeared to be static. Both the regulatory bodies and the industry should ensure complete and clear reporting of all endpoints used, including PROs, to improve transparency.en
dc.format.extent11
dc.language.isoeng
dc.relation.ispartofJournal of Epidemiology and Global Health
dc.subjectEuropean Medicines Agency
dc.subjectEuropean Public Assessment Report
dc.subjectHealth related quality of health
dc.subjectPatient reported outcomes
dc.subjectEpidemiology
dc.titleRole of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008-2012)en
dc.contributor.institutionDepartment of Pharmacy, Pharmacology and Postgraduate Medicine
dc.description.statusPeer reviewed
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=84946495377&partnerID=8YFLogxK
rioxxterms.versionVoR
rioxxterms.versionofrecordhttps://doi.org/10.1016/j.jegh.2015.04.006
rioxxterms.typeJournal Article/Review
herts.preservation.rarelyaccessedtrue


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