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Sökning: onr:"swepub:oai:DiVA.org:uu-501855" > Real world evidence :

  • Szymanski, PiotrNatl Inst Med MSW, Clin Cardiol Dept, Warsaw, Poland.;Ctr Postgrad Med Educ, Warsaw, Poland. (författare)

Real world evidence : Perspectives from a European Society of Cardiology Cardiovascular Round Table with contribution from the European Medicines Agency

  • Artikel/kapitelEngelska2023

Förlag, utgivningsår, omfång ...

  • 2023-02-06
  • Oxford University Press,2023
  • printrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:uu-501855
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-501855URI
  • https://doi.org/10.1093/ehjqcco/qcad009DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • 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.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Weidinger, FranzKlin Landstrasse, 2nd Med Dept Cardiol & Intens Care Med, Vienna, Austria. (författare)
  • Lordereau-Richard, IsabelleAmgen Europe, Gen Med Europe, Rotkreutz ZG, Switzerland. (författare)
  • Himmelmann, AndersBioPharmaceut R&D, Late stage Dev Cardiovasc Renal & Metab CVRM Clin, AstraZeneca, Gothenburg, Sweden. (författare)
  • Arca, MarcelloSapienza Univ Rome, Hosp Policlin Umberto1, Dept Translat & Precis Med, Rome, Italy. (författare)
  • Chaves, JosePfizer Biopharmaceut Grp, Internal Med Business Unit, Global Med Affairs, Madrid, Spain. (författare)
  • Lee, CharlesAstraZeneca, BioPharmaceut R&D, Late Dev Cardiovasc, Renal & Metab CVRM Regulatory Affairs, Gaithersburg, MD USA. (författare)
  • Jonker, CarlaEuropean Med Agcy, Data Analyt & Methods Task Force, Amsterdam, Netherlands. (författare)
  • Kotecha, DipakUniv Birmingham, Univ Hosp Birmingham NHS Fdn Trust, Inst Cardiovasc Sci, Birmingham, England. (författare)
  • O'Kelly, JamesAmgen Inc, Ctr Observat Res CfOR, Cambridge, England. (författare)
  • Plueschke, KellyEuropean Med Agcy, Data Analyt & Methods Task Force, Amsterdam, Netherlands. (författare)
  • Rys, AndrzejEuropean Commiss, Hlth Syst, Med Prod & Innovat, Directorate Gen Hlth & Food Safety DG St E, Brussels, Belgium. (författare)
  • Segec, AndrejEuropean Med Agcy, Data Analyt & Methods Task Force, Amsterdam, Netherlands. (författare)
  • Wallentin, Lars,1943-Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)(Swepub:uu)larswall (författare)
  • Veltrop, RogierMaastricht Univ, Dept Biochem, CARIM, Maastricht, Netherlands.;RWTH Aachen Univ Hosp, Inst Mol Cardiovasc Res IMCAR, Aachen, Germany. (författare)
  • James, Stefan,1964-Uppsala universitet,Kardiologi(Swepub:uu)stjam367 (författare)
  • 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)

Sammanhörande titlar

  • Ingår i:European Heart Journal - Quality of Care and Clinical Outcomes: Oxford University Press9:2, s. 109-1182058-52252058-1742

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