Kklinikuri farmakologiis da samedicino kvlevebis departamenti

P vaxtang WumburiZeA

30 ianvari 2012

kardiologiis da klinikuri farmakologiis ganyofileba1988 weli – daarsda kardiologiis da klinikuri

farmakologiis ganyofilebamizani : 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 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

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.

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 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 (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)

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 :

mwvave koronaruli sindromi -7

gulis ukmarisoba – 5 + 1

stabiluri stenokardia – 4 + 1 +1

miokardiumis mwvave infarqti – 4 arteriuli hipertenzia – 2

iSemiuri kardiomiopaTia – 1

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)

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 egidiTEURO HEART SURVEY nozologiebis mixedviT:stenokardiaarteriuli hipertenziamwvave 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: 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

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

10 study sites in Tbilisi, 10 study sites in Tbilisi, GeorgiaGeorgia