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Real world evidence :
Real world evidence : Perspectives from a European Society of Cardiology Cardiovascular Round Table with contribution from the European Medicines Agency
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- Szymanski, Piotr (author)
- Natl Inst Med MSW, Clin Cardiol Dept, Warsaw, Poland.;Ctr Postgrad Med Educ, Warsaw, Poland.
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- Weidinger, Franz (author)
- Klin Landstrasse, 2nd Med Dept Cardiol & Intens Care Med, Vienna, Austria.
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- Lordereau-Richard, Isabelle (author)
- Amgen Europe, Gen Med Europe, Rotkreutz ZG, Switzerland.
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- Himmelmann, Anders (author)
- BioPharmaceut R&D, Late stage Dev Cardiovasc Renal & Metab CVRM Clin, AstraZeneca, Gothenburg, Sweden.
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- Arca, Marcello (author)
- Sapienza Univ Rome, Hosp Policlin Umberto1, Dept Translat & Precis Med, Rome, Italy.
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- Chaves, Jose (author)
- Pfizer Biopharmaceut Grp, Internal Med Business Unit, Global Med Affairs, Madrid, Spain.
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- Lee, Charles (author)
- AstraZeneca, BioPharmaceut R&D, Late Dev Cardiovasc, Renal & Metab CVRM Regulatory Affairs, Gaithersburg, MD USA.
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- Jonker, Carla (author)
- European Med Agcy, Data Analyt & Methods Task Force, Amsterdam, Netherlands.
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- Kotecha, Dipak (author)
- Univ Birmingham, Univ Hosp Birmingham NHS Fdn Trust, Inst Cardiovasc Sci, Birmingham, England.
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- O'Kelly, James (author)
- Amgen Inc, Ctr Observat Res CfOR, Cambridge, England.
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- Plueschke, Kelly (author)
- European Med Agcy, Data Analyt & Methods Task Force, Amsterdam, Netherlands.
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- Rys, Andrzej (author)
- European Commiss, Hlth Syst, Med Prod & Innovat, Directorate Gen Hlth & Food Safety DG St E, Brussels, Belgium.
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- Segec, Andrej (author)
- European Med Agcy, Data Analyt & Methods Task Force, Amsterdam, Netherlands.
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- Wallentin, Lars, 1943- (author)
- Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)
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- Veltrop, Rogier (author)
- Maastricht Univ, Dept Biochem, CARIM, Maastricht, Netherlands.;RWTH Aachen Univ Hosp, Inst Mol Cardiovasc Res IMCAR, Aachen, Germany.
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- James, Stefan, 1964- (author)
- Uppsala universitet,Kardiologi
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Natl Inst Med MSW, Clin Cardiol Dept, Warsaw, Poland;Ctr Postgrad Med Educ, Warsaw, Poland. Klin Landstrasse, 2nd Med Dept Cardiol & Intens Care Med, Vienna, Austria. (creator_code:org_t)
- 2023-02-06
- 2023
- English.
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In: European Heart Journal - Quality of Care and Clinical Outcomes. - : Oxford University Press. - 2058-5225 .- 2058-1742. ; 9:2, s. 109-118
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Health Care Service and Management, Health Policy and Services and Health Economy (hsv//eng)
Keyword
- DARWIN EU
- Electronic healthcare records
- EuroHeart
- Fit-for-purpose registries
- Registry-based randomised clinical trials
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Szymanski, Piotr
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Weidinger, Franz
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Lordereau-Richar ...
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Himmelmann, Ande ...
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Arca, Marcello
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Chaves, Jose
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Lee, Charles
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Jonker, Carla
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Kotecha, Dipak
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O'Kelly, James
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Plueschke, Kelly
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Rys, Andrzej
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Segec, Andrej
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Wallentin, Lars, ...
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Veltrop, Rogier
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James, Stefan, 1 ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Health Sciences
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and Health Care Serv ...
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European Heart J ...
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Uppsala University