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Search: L773:2058 1742 > (2023) > Real world evidence :

LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00005623naa a2200553 4500
001oai:DiVA.org:uu-501855
003SwePub
008230522s2023 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-5018552 URI
0247 a https://doi.org/10.1093/ehjqcco/qcad0092 DOI
040 a (SwePub)uu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Szymanski, Piotru Natl Inst Med MSW, Clin Cardiol Dept, Warsaw, Poland.;Ctr Postgrad Med Educ, Warsaw, Poland.4 aut
2451 0a Real world evidence :b Perspectives from a European Society of Cardiology Cardiovascular Round Table with contribution from the European Medicines Agency
264 c 2023-02-06
264 1b Oxford University Press,c 2023
338 a print2 rdacarrier
520 a Real world data (RWD) refers to healthcare information that is routinely collected in electronic healthcare records (EHR), hospital and pharmacy records, patient and disease registries, and health insurance databases. The collection and analysis of this vast amount of data is an important complement to that obtained from conventional randomised controlled trials (RCT). Real world data has been used for healthcare quality improvements, to conduct clinical trials, to support drug and device development, and to inform medical guidelines. The utility of RWD may be facilitated by common data models, which standardise format and content, and allow data from different health systems to be analysed together.The European Society of Cardiology (ESC) supports the use of RWD in collaboration with national cardiac societies, regulatory authorities, and industry to encourage continuous quality of care improvements at the hospital and country level, to conduct registry-based randomised clinical trials (R-RCT) and to facilitate safety surveillance of novel drugs and devices.The European Medicines Agency (EMA) is developing systems and processes to enable the use of RWD that can help in trial planning, defining clinical contexts, and enhancing outcome assessments. RWD can also contribute to the measurement of the impact of regulatory actions, such as contraindications or restriction of indications by looking at medicines use patterns over time across European Member States. A number of other initiatives from the European Commission and the EMA are underway to strengthen the EU's health security framework, and foster the collection and utilisation of RWD.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Kardiologi0 (SwePub)302062 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cardiac and Cardiovascular Systems0 (SwePub)302062 hsv//eng
650 7a MEDICIN OCH HÄLSOVETENSKAPx Hälsovetenskapx Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi0 (SwePub)303012 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Health Sciencesx Health Care Service and Management, Health Policy and Services and Health Economy0 (SwePub)303012 hsv//eng
653 a DARWIN EU
653 a Electronic healthcare records
653 a EuroHeart
653 a Fit-for-purpose registries
653 a Registry-based randomised clinical trials
7001 a Weidinger, Franzu Klin Landstrasse, 2nd Med Dept Cardiol & Intens Care Med, Vienna, Austria.4 aut
7001 a Lordereau-Richard, Isabelleu Amgen Europe, Gen Med Europe, Rotkreutz ZG, Switzerland.4 aut
7001 a Himmelmann, Andersu BioPharmaceut R&D, Late stage Dev Cardiovasc Renal & Metab CVRM Clin, AstraZeneca, Gothenburg, Sweden.4 aut
7001 a Arca, Marcellou Sapienza Univ Rome, Hosp Policlin Umberto1, Dept Translat & Precis Med, Rome, Italy.4 aut
7001 a Chaves, Joseu Pfizer Biopharmaceut Grp, Internal Med Business Unit, Global Med Affairs, Madrid, Spain.4 aut
7001 a Lee, Charlesu AstraZeneca, BioPharmaceut R&D, Late Dev Cardiovasc, Renal & Metab CVRM Regulatory Affairs, Gaithersburg, MD USA.4 aut
7001 a Jonker, Carlau European Med Agcy, Data Analyt & Methods Task Force, Amsterdam, Netherlands.4 aut
7001 a Kotecha, Dipaku Univ Birmingham, Univ Hosp Birmingham NHS Fdn Trust, Inst Cardiovasc Sci, Birmingham, England.4 aut
7001 a O'Kelly, Jamesu Amgen Inc, Ctr Observat Res CfOR, Cambridge, England.4 aut
7001 a Plueschke, Kellyu European Med Agcy, Data Analyt & Methods Task Force, Amsterdam, Netherlands.4 aut
7001 a Rys, Andrzeju European Commiss, Hlth Syst, Med Prod & Innovat, Directorate Gen Hlth & Food Safety DG St E, Brussels, Belgium.4 aut
7001 a Segec, Andreju European Med Agcy, Data Analyt & Methods Task Force, Amsterdam, Netherlands.4 aut
7001 a Wallentin, Lars,d 1943-u Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)4 aut0 (Swepub:uu)larswall
7001 a Veltrop, Rogieru Maastricht Univ, Dept Biochem, CARIM, Maastricht, Netherlands.;RWTH Aachen Univ Hosp, Inst Mol Cardiovasc Res IMCAR, Aachen, Germany.4 aut
7001 a James, Stefan,d 1964-u Uppsala universitet,Kardiologi4 aut0 (Swepub:uu)stjam367
7102 a Natl Inst Med MSW, Clin Cardiol Dept, Warsaw, Poland.;Ctr Postgrad Med Educ, Warsaw, Poland.b Klin Landstrasse, 2nd Med Dept Cardiol & Intens Care Med, Vienna, Austria.4 org
7730 t European Heart Journal - Quality of Care and Clinical Outcomesd : Oxford University Pressg 9:2, s. 109-118q 9:2<109-118x 2058-5225x 2058-1742
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-501855
8564 8u https://doi.org/10.1093/ehjqcco/qcad009

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