Kklinikuri farmakologiis da samedicino kvlevebis departamenti
P vaxtang WumburiZe
A
30 ianvari 2012
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
Mmulticentruli klinikuri kvelvebidan yoveldRiur klinikur
praqtikamde
Mmulticentuli, multinacionaluri klinikuri kvlevebi
saerTaSoriso rekomendaciebi (gaidlainebi)
Mmkurnalobis meTodebis observaciuli kvleva (Sesabamisoba/ Seusabamoba gaidlainTan)
klinikuri kvlevebi saqarTveloSi
1988-1997 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
Kklinikuri kvlevebi saqarTveloSi: 1997 - 2011
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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.
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
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
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CROMOS
PHARMATHERA
PARAXEL
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 (20042005, 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)
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)
Kklinikuri kvlevebi saqarTveloSi
kardiovaskuluri mimarTulebiT Catarebuli klinikuri kvlevebi – 21 :
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mwvave koronaruli sindromi -7
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gulis ukmarisoba – 5 + 1
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stabiluri stenokardia – 4 + 1 +1
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miokardiumis mwvave infarqti – 4
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arteriuli hipertenzia – 2
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iSemiuri kardiomiopaTia – 1
Kklinikuri kvlevebi saqarTveloSi:
mimdinare
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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)
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)
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
Mmulticentruli klinikuri kvelvebidan yoveldRiur klinikur
praqtikamde
Mmulticentuli, multinacionaluri klinikuri kvlevebi
saerTaSoriso rekomendaciebi (gaidlainebi)
Mmkurnalobis meTodebis observaciuli kvleva (Sesabamisoba/ Seusabamoba gaidlainTan)
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)
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
Kklinikuri farmakologiis da samedicino kvlevebis departamenti
ZiriTadi klinikuri mimarTuleba:
maRali riskis mqone pacientebis marTva gulis
qronikuli daavadebebis da maTTan SeuRlebuli
Tanmxlebi paTologiis arsebobisas:
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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
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
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So are trials a good thing, have they improved healthcare?
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Formal record of clinical trials dates back to the time of the
“Trialists”:
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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
10 study sites in Tbilisi,
Georgia