Sökning: onr:"swepub:oai:DiVA.org:uu-501855" > Real world evidence :
Fältnamn | Indikatorer | Metadata |
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000 | 05623naa a2200553 4500 | |
001 | oai:DiVA.org:uu-501855 | |
003 | SwePub | |
008 | 230522s2023 | |||||||||||000 ||eng| | |
024 | 7 | a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-5018552 URI |
024 | 7 | a https://doi.org/10.1093/ehjqcco/qcad0092 DOI |
040 | a (SwePub)uu | |
041 | a engb eng | |
042 | 9 SwePub | |
072 | 7 | a ref2 swepub-contenttype |
072 | 7 | a art2 swepub-publicationtype |
100 | 1 | a Szymanski, Piotru Natl Inst Med MSW, Clin Cardiol Dept, Warsaw, Poland.;Ctr Postgrad Med Educ, Warsaw, Poland.4 aut |
245 | 1 0 | a 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 | 1 | b 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 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Kardiologi0 (SwePub)302062 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cardiac and Cardiovascular Systems0 (SwePub)302062 hsv//eng |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Hälsovetenskapx Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi0 (SwePub)303012 hsv//swe |
650 | 7 | a 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 | |
700 | 1 | a Weidinger, Franzu Klin Landstrasse, 2nd Med Dept Cardiol & Intens Care Med, Vienna, Austria.4 aut |
700 | 1 | a Lordereau-Richard, Isabelleu Amgen Europe, Gen Med Europe, Rotkreutz ZG, Switzerland.4 aut |
700 | 1 | a Himmelmann, Andersu BioPharmaceut R&D, Late stage Dev Cardiovasc Renal & Metab CVRM Clin, AstraZeneca, Gothenburg, Sweden.4 aut |
700 | 1 | a Arca, Marcellou Sapienza Univ Rome, Hosp Policlin Umberto1, Dept Translat & Precis Med, Rome, Italy.4 aut |
700 | 1 | a Chaves, Joseu Pfizer Biopharmaceut Grp, Internal Med Business Unit, Global Med Affairs, Madrid, Spain.4 aut |
700 | 1 | a Lee, Charlesu AstraZeneca, BioPharmaceut R&D, Late Dev Cardiovasc, Renal & Metab CVRM Regulatory Affairs, Gaithersburg, MD USA.4 aut |
700 | 1 | a Jonker, Carlau European Med Agcy, Data Analyt & Methods Task Force, Amsterdam, Netherlands.4 aut |
700 | 1 | a Kotecha, Dipaku Univ Birmingham, Univ Hosp Birmingham NHS Fdn Trust, Inst Cardiovasc Sci, Birmingham, England.4 aut |
700 | 1 | a O'Kelly, Jamesu Amgen Inc, Ctr Observat Res CfOR, Cambridge, England.4 aut |
700 | 1 | a Plueschke, Kellyu European Med Agcy, Data Analyt & Methods Task Force, Amsterdam, Netherlands.4 aut |
700 | 1 | a Rys, Andrzeju European Commiss, Hlth Syst, Med Prod & Innovat, Directorate Gen Hlth & Food Safety DG St E, Brussels, Belgium.4 aut |
700 | 1 | a Segec, Andreju European Med Agcy, Data Analyt & Methods Task Force, Amsterdam, Netherlands.4 aut |
700 | 1 | a Wallentin, Lars,d 1943-u Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)4 aut0 (Swepub:uu)larswall |
700 | 1 | a Veltrop, Rogieru Maastricht Univ, Dept Biochem, CARIM, Maastricht, Netherlands.;RWTH Aachen Univ Hosp, Inst Mol Cardiovasc Res IMCAR, Aachen, Germany.4 aut |
700 | 1 | a James, Stefan,d 1964-u Uppsala universitet,Kardiologi4 aut0 (Swepub:uu)stjam367 |
710 | 2 | 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 |
773 | 0 | 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 |
856 | 4 8 | u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-501855 |
856 | 4 8 | u https://doi.org/10.1093/ehjqcco/qcad009 |
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