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1. Kklinikuri farmakologiis da samedicino kvlevebis departamenti P vaxtang WumburiZe A 30 ianvari 2012

2. kardiologiis da klinikuri farmakologiis ganyofileba 1988 weli – daarsda kardiologiis da klinikuri farmakologiis ganyofileba mizani : mkurnalobis axali principebis SemuSaveba kardiologiaSi saerTaSoriso multicentrul kvlevebSi monawileoba farmakokinetikuri kvlevebis warmoeba yoveldRiur klinikur praqtikaSi saerTaSoriso rekomendaciebis danergva

3. Mmulticentruli klinikuri kvelvebidan yoveldRiur klinikur praqtikamde Mmulticentuli, multinacionaluri klinikuri kvlevebi saerTaSoriso rekomendaciebi (gaidlainebi) Mmkurnalobis meTodebis observaciuli kvleva (Sesabamisoba/ Seusabamoba gaidlainTan)

4. klinikuri kvlevebi saqarTveloSi1988-1997 wlebi Sesrulebulia Semdegi proeqtebi: Kkaptoprili digoqsinis winaamRdeg gulis ukmarisobis mkurnalobisas (1988 -1991,BMS) Bbisoprololis hipotenziuri da antianginaluri efeqtebis Sedareba metoprololTan ormagi –brma meTodis gamoyenebiT (1990-1992, Merck) Pplendilis da adalatis SedarebiTi efeqturoba arteriuli hipertenziis mkurnalobisas (1990-1992, Astra Zeneka) zirtekis efeqturobis Sefaseba bronquli asTmis mkurnalobisas (1988-1991, Jansen) Aamlodipinis da lacidipinis hipotenziuri da antiiSemiuri efeqturobis Sefaseba ormagi-brma, multicentruli, multinacionaluri kvleva ( 1995-1997,Glaxo Welcome) - monitoringi – verona, italia

5. Kklinikuri kvlevebi saqarTveloSi: 1997 - 2011 • 1997 weli – kanoni “wamlis da farmaciis Sesaxeb” miRebul iqna parlamentis mier • 1997 wlidan – yvela klinikuri kvleva saqarTveloSi Catarda ICH GCP standartis dacviT • amave droidan ganviTarda eTikuri komitetebis sistema da 9 IRB (Institutional Review Board) miiRo FWA (Federalwide Assurance) adamianTa dacvis TvalsazrisiT (US Department of Health and Human Services) • 1997-dRemde tardeba uwyveti GCP (Good Clinical Practice) kursebi qarTveli mkvlevarebisaTvis, ramac ganapiroba kvlevebis warmoebis maRali xarsixi. • GCP (Good Clinical Practice) standartis dacva saqarTveloSi mravaljer iqna aRiarebuli rogorc sponsoris, aseve damoukidebeli auditoruli kompaniebis mier, gansakuTrebiT aRsaniSnavia FDA (Food and Drug Administration) mier Catarebuli inspeqciebis Sedegebi. • saqaTvelos mier miwodebuli klinikuri kvlevebis masala yovelTvis samagaliTod ganixileboda.

6. Kklinikuri kvlevebi saqarTveloSi dReisaTvis Dklinikuri kvlevebis warmoeba saqarTveloSi regulirdeba Semdegi kanonmdeblobiT: • Kkanoni “wamlisa da farmaciis” Sesaxeb, 1997 wlis aprili • Kkanoni “licenzirebisa da approval “ Sesaxeb, 2005 wlis noemberi • BbrZaneba #176 “ klinikuri kvlevebis warmoebis wesebi da mdgomareobebi”, 2005 wlis oqtomberi • saqrTvelos janmrTelobis da socialuri dacvis saministros brZaneba # 233 “klinikuri kvlevebis warmoebis International Conference on Hatmonization ICH Guideline for Good Clinical Practice GCP E6, 1996 mixedviT”, 2010 weli, agvisto

7. Kklinikuri kvlevebi saqarTveloSi CRO (Clinical Research Organization) – klinikuri kvelvis warmatebiT Catarebis sawindari • WCT Georgia – 1998 wlidan (winaT Evidence Georgia), gamoirCeva: kvlevaSi CarTvis maRali maCveneblebiT kvlevis warmoebis nebarTvis srafi miRweviT ICH da FDA GCP standartis mudmivi danergviT maRali donis gamocdili monitorebis gundiT klinikuri centrebis didi monacemTa baziT Tanamedrove sakomunikacio teqnologiebis, centraluri CTM deposa da logistikuri momsaxurebis arsebobiT • CROMOS • PHARMATHERA • PARAXEL

8. Kklinikuri kvlevebi 2000 wlidan(saerTaSoriso, kontrolirebadi, multicentruli, ormagi-brma) ranolazonis efeqturobis Sefaseba pacientebSi stabiluri stenokardiiT (2001-2002, CV Terapeutics) ranolazinis efeqturobis Sefaseba pacientebSi gulis qronikuli iSemiuri daavadebiT, (2002-2003, CV Terapeutics) ranolazinis efeqturobis da usafrTxoebis Sefaseba pacientebSi mwvave koronaruli sindromiT (2004-2005, CV Terapeutics) antiTrombulis Terapiis (AZD/klopidogreli) efeqturobis SedarebiTi Sefaseba pacientebSi mwvave koronaruli sindromiT, (2006-2007, Astra Zeneka) dabigartanis da klopidogrelis efeqturobis SedarebiTi Sefaseba pacientebSi mwvave koronaruli sindromiT, (2007-2009, BI)

9. Kklinikuri kvlevebi 2000 wlidan(saerTaSoriso, kontrolirebadi, multicentruli, ormagi-brma) telmisrtanis da telmisartani/hidroqlortiazidis efeqturobis Sefaseba pacientebSi arteriuli hipertenziiT, (2009, BI) CY1221 efeqturobis Sefaseba pacientebSi iSemiuri kardiomiopaTiiT da stabiluri stenokardiiT, (2008-2009, Cytokinetics) RLY5016 efeqturobis Sefaseba pacientebSi gulis ukmarisobiT da Tirkmlis qronikuli ukmarisobiT, (2009, RELYPSA) mildronatis gamoyenebis efeqturobis da usafrTxoebis Sefaseba pacientebSi stabiluri stenokardiiT, (2008-2010,Grindex, 2 sites) AN-CVD -2224 gamoyenebis efeqturobis da usafrTxoebis Sefaseba pacientebSi mwvave koronaruli sindromiT, (2008-2010,AAnthera)

10. Kklinikuri kvlevebi saqarTveloSi kardiovaskuluri mimarTulebiT Catarebuli klinikuri kvlevebi – 21 : • mwvave koronaruli sindromi -7 • gulis ukmarisoba – 5 + 1 • stabiluri stenokardia – 4 + 1 +1 • miokardiumis mwvave infarqti – 4 • arteriuli hipertenzia – 2 • iSemiuri kardiomiopaTia – 1

11. Kklinikuri kvlevebi saqarTveloSi:mimdinare • TOPCAT - aldosteronis antagonistebis gamoyeneba pacientebSi gulis diastoluri ukmarisobiT, (2006 , NIH) • BI/205.452 - tiotropiumis bromidis sxvadasxva formebis gamoyenebis SedarebiTi efeqturobis Sefaseba pacientebSi filtvis qronikuli obstruqciuli daavadebiT, (2010, BI) • CLEOPATRA - pentalongis klinikuri efeqturobis Sefaseba pacientebSi stabiluri stenokardiiT, (2011, Cromos) • CTST 21 - polieleqtrolitis efeqturobis Sefaseba pacientebSi gulis ukmarisobiT da Tirkmlis qronikuli ukmarisobiT, (2011, Sorbent) • AMETHYST - RLY5016 efeqturobis Sefaseba pacientebSi Saqriani diabetiT da Tirkmlis qronikuli ukmarisobiT, (2011, Relypsa) • VISTA16 - AN-CVD2233 efeqturobis Sefaseba pacientebSi mwvave koronaruli sindromiT, (2010, AAnthera) • CHAMPION - pacientebi mwvave koronaruli sindromiT da koronaruli intervenciiT (2011, PPhoenix)

12. Kklinikuri kvlevebi saqarTveloSi ZiriTadi samecniero publikaciebis CamonaTvali saqarTveloSi Catarebuli klinikuri kvlevebis masalis gamoyenebiT: • 1997-2000: CEDIM-2 , Myocardial Infarction (Am Heart J, 2000) • 1998-2001: HERO -2 , Myocardial Infarction (Lancet , 2001) • 2000-2002: MAGIC , Myocardial Infarction (Lancet, 2002) • 2001-2002: CARISA, Stable Angina (Circulation, 2001) • 2002-2003 : CARISA, Stable Angina (JAMA, 2004) • 2005-2006 : MERLIN, Myocardial Infarction (JAMA, 2007 Circulation, 2007) • 2007-2008: DIRECT, Diabetes Mellitus (Lancet, 2008) • 2006-2009: PLATO, Acute Coronary Syndrome (NEJM, 2009) • 2009-2010: REDEEM, Acute Coronary Syndrome (Lancet, 2010)

13. saerTaSoriso epidemiologiuri kvlevebi evropis kardiologTa sazogadoebis egidiT EURO HEART SURVEY nozologiebis mixedviT: stenokardia arteriuli hipertenzia mwvave koronaruli sindromi da a.S Ddiabeti da guli Ggulis qronikuli ukmarisobis epidemiologiis/mkurnalobis meTodebis observaciuli kvleva, 2011-2012 wlebi

14. Mmulticentruli klinikuri kvelvebidan yoveldRiur klinikur praqtikamde Mmulticentuli, multinacionaluri klinikuri kvlevebi saerTaSoriso rekomendaciebi (gaidlainebi) Mmkurnalobis meTodebis observaciuli kvleva (Sesabamisoba/ Seusabamoba gaidlainTan)

15. Mmomavali klinikuri kvlevebi • ivabradinis efeqturobis Sefaseba pacientebSi guli skoronaruli daavadebiT (SIGNIFY, Servie) • Fflutikazonis furiatis/vilanterolis efeqturobis kvleva pacientebSi filtvis qronikuli obstruqciuli daavadebiT (SUMMIT, GlaxoSK) • ranolazinis efeqturobis Seswavla pacientebSi stabiluri stenokardiiT da Saqriani diabetiT tipi 2 (Gillard)

16. Kklinikuri farmakologiis da samedicino kvlevebis departamenti Mmiznebi: Mmkurnalobis Tanamedrove principebis danergva da racionalizacia swori klinikuri praqtikis “GCP”danergva da monitoringi Eevropis kardiologTa sazogadoebis gaidlainebis danergva yoveldRiur praqtikaSi saerTaSoriso, multicentruli, multinacionaluri klinikuri kvlevebis warmoeba saerTaSorisoKklinikuri kvlevebis organizaciebTan “CRO”urTierTkavSiri

17. Kklinikuri farmakologiis da samedicino kvlevebis departamenti ZiriTadi klinikuri mimarTuleba: maRali riskis mqone pacientebis marTva gulis qronikuli daavadebebis da maTTan SeuRlebuli Tanmxlebi paTologiis arsebobisas: • Aarteriuli hipertenziis rezistentuli formebi • Ddiabeti da guli • Ggulis qronikuli ukmarisoba da Tirkmlis ukmarisoba (e.w. “kardio-renaluri sindromi”) • kardiomiopaTia da miokarditi • kardio-pulmonaruli sindromi • gulis dismetaboluri da dishormonaluri daavadebebi

18. What is a Clinical Trial A properly planned and executed clinical trial is a powerful experimental technique for assessing the effectiveness of an intervention Aadekvaturad dagegmili da warmoebuli klinikuri kvleva warmoadgens mZlavr eqsperimentul saSualebas samedicino Carevis Sesafaseblad

19. So are trials a good thing, have they improved healthcare? • Formal record of clinical trials dates back to the time of the “Trialists”: • Dr. Van Helmont’s proposal for a therapeutic trial of bloodletting for fevers [1628] • Dr. Lind’s, a ship surgeon, trial of oranges & limes for scurvy [1747] • Historical Highlights of Drug Trials • 1909: Paul Ehrlich - Arsphenamine • 1929: Alexander Fleming - Penicillin • 1935: Gerhard Domagk - Sulfonamide • 1944: Schatz/Bugie/Waksman – Streptomycin • By 1950, the British Medical Res. Council developed a systematic methodology for studying & evaluating therapeutic interventions

20. 10 study sites in Tbilisi, Georgia