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  • Bueno, HectorCtr Nacl Invest Cardiovasc, Melchor Fernandez Almagro 3, Madrid 28029, Spain;Hosp Univ 12 Octubre, Cardiol Dept, Madrid, Spain;Univ Complutense Madrid, Madrid, Spain (author)

Report of the European Society of Cardiology Cardiovascular Round Table regulatory workshop update of the evaluation of new agents for the treatment of acute coronary syndrome : Executive summary

  • Article/chapterEnglish2019

Publisher, publication year, extent ...

  • 2016-06-29
  • SAGE PUBLICATIONS LTD,2019
  • printrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:uu-400681
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-400681URI
  • https://doi.org/10.1177/2048872616649859DOI

Supplementary language notes

  • Language:English
  • Summary in:English

Part of subdatabase

Classification

  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Regulatory authorities interpret the results of randomized controlled trials according to published principles. The European Medicines Agency (EMA) is planning a revision of the 2000 and 2003 guidance documents on clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) to achieve consistency with current knowledge in the field. This manuscript summarizes the key output from a collaborative workshop, organized by the Cardiovascular Round Table and the European Affairs Committee of the European Society of Cardiology, involving clinicians, academic researchers, trialists, European and US regulators, and pharmaceutical industry researchers. Specific questions in four key areas were selected as priorities for changes in regulatory guidance: patient selection, endpoints, methodologic issues and issues related to the research for novel agents. Patients with ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) should be studied separately for therapies aimed at the specific pathophysiology of either condition, particularly for treatment of the acute phase, but can be studied together for other treatments, especially long-term therapy. Unstable angina patients should be excluded from acute phase ACS trials. In general, cardiovascular death and reinfarction are recommended for primary efficacy endpoints; other endpoints may be considered if specifically relevant for the therapy under study. New agents or interventions should be tested against a background of evidence-based therapy with expanded follow-up for safety assessment. In conclusion, new guidance documents for randomized controlled trials in ACS should consider changes regarding patient and endpoint selection and definitions, and trial designs. Specific requirements for the evaluation of novel pharmacological therapies need further clarification.

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • de Graeff, PieterUniv Groningen, Dept Clin Pharm & Pharmacol, Groningen, Netherlands;Dutch Med Evaluat Board, Utrecht, Netherlands (author)
  • Richard-Lordereau, IsabelleBristol Myers Squibb, Rueil Malmaison, France (author)
  • Emmerich, JosephUniv Paris 05, Cochin Hotel Dieu Hosp, French Natl Agcy Med & Hlth Prod Safety, Paris, France (author)
  • Fox, Keith A. A.Univ Edinburgh, Ctr Cardiovasc Sci, Edinburgh, Midlothian, Scotland;Royal Infirm Edinburgh NHS Trust, Edinburgh, Midlothian, Scotland (author)
  • Friedman, Carola P.Novartis Pharmaceut, E Hanover, NJ USA (author)
  • Gaudin, ChristopheSanofi, Paris, France (author)
  • El-Gazayerly, AmanyDutch Med Evaluat Board, Utrecht, Netherlands (author)
  • Goldman, SamanthaDaiichi Sankyo Dev Ltd, Gerrards Cross, England (author)
  • Hemmrich, MelanieBayer Pharma AG Inc, Berlin, Germany (author)
  • Henderson, Robert A.Nottingham Univ Hosp, Trent Cardiac Ctr, Nottingham, England (author)
  • Himmelmann, AndersAstraZeneca R&D, Molndal, Sweden (author)
  • Irs, AlarUniv Tartu, Dept Cardiol, Tartu, Estonia;Estonian State Agcy Med, Tartu, Estonia (author)
  • Jackson, NevillePfizer Inc, Richmond, VA USA (author)
  • James, Stefan,1964-Uppsala universitet,Kardiologi(Swepub:uu)stjam367 (author)
  • Katus, Hugo A.Univ Klinikum Heidelberg, Med Klin, Heidelberg, Germany (author)
  • Laslop, AndreaAustrian Agcy Hlth & Food Safety, Vienna, Austria (author)
  • Laws, IanGlaxoSmithKline, London, England (author)
  • Mehran, RoxanaZena & Michael A Wiener Cardiovasc Inst, New York, NY USA (author)
  • Ong, SeleenPfizer Inc, Sandwich, Kent, England (author)
  • Prasad, KrishnaMed & Healthcare Prod Regulatory Agcy, London, England;Univ London, St Thomas Hosp, London, England (author)
  • Roffi, MarcoUniv Hosp, Dept Cardiol, Geneva, Switzerland (author)
  • Rosano, Giuseppe M. C.San Raffaele Hosp Roma, IRCCS, Rome, Italy;Univ London, Cardiovasc & Cell Sci Inst, London, England (author)
  • Rose, MartinUS FDA, Rockville, MD 20857 USA (author)
  • Sinnaeve, Peter R.Univ Leuven, Dept Cardiovasc Sci, Leuven, Belgium (author)
  • Stough, Wendy GattisCampbell Univ, Coll Pharm & Hlth Sci, Buies Creek, NC 27506 USA (author)
  • Thygesen, KristianAarhus Univ Hosp, Dept Cardiol, Aarhus, Denmark (author)
  • Van de Werf, FransUniv Leuven, Dept Cardiovasc Sci, Leuven, Belgium (author)
  • Varin, ClaireInst Rech Int Servier, Suresnes, France (author)
  • Verheugt, Freek W. A.OLVG, Amsterdam, Netherlands (author)
  • Garcia, Maria de los Angeles AlonsoEuropean Med Agcy, Sci Advice Working Party, London, England;Imperial Coll Healthcare, Cardiol, London, England (author)
  • Ctr Nacl Invest Cardiovasc, Melchor Fernandez Almagro 3, Madrid 28029, Spain;Hosp Univ 12 Octubre, Cardiol Dept, Madrid, Spain;Univ Complutense Madrid, Madrid, SpainUniv Groningen, Dept Clin Pharm & Pharmacol, Groningen, Netherlands;Dutch Med Evaluat Board, Utrecht, Netherlands (creator_code:org_t)

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