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Rozhovor mesiaca: Klinické skúšanie predstavuje novú nádej pre pacientov


 | 5.6.2015 | komentárov: 282

25. júna 2015 sa v Bratislave uskutoční konferencia "Transparentnosť klinického skúšania", ktorej spoluorganizátorom je aj Komora pre medicínske právo – MEDIUS.

Obrazok

O tom, aký je aktuálny stav klinického skúšania na Slovensku, nám porozprávala odborná garantka konferencie, Katarína Kováčová.

Pre mnohých z nás je transparentnosť cudzie slovo. Čo si máme pod ním predstaviť?

Transparentnosť je pekné slovo, znamená priehľadný, priesvitný, ale aj zrejmý, či jasný. Transparentnosť je dobrá v každom odvetví. Na základe jasnosti, zrejmosti a priehľadnosti, bude daná činnosť, výrobok, alebo produkt viac uveriteľný, bezpečný a čistý – a je jedno, o akom odvetví hovoríme. V inovácií liekov, alebo v rámci liečebných postupov či diagnostiky, musí byť jasné, akým spôsob sa prišlo k dátam, na základe ktorých nás bude lekár liečiť, diagnostikovať.

Aká je cena inovácií?

Z môjho pohľadu, nevyčísliteľná – ak vieme zrátať, koľko stojí ľudský život, či zlepšená kvalita života pri ochorení človeka.

Ale existujú aj exaktné dáta. EFPIA (Europien Deferation of Pharmaceutical Industires and Associations) vyčíslila, že na inováciu minula v roku 2011 27.5 miliárd EUR. Za každou inováciou musíme vidieť obrovské množstvo odborníkov a účastníkov výskumu. Od nápadu k liečbe, ubehne dlhá doba (viac ako 13 rokov, EFPIA 2011). 


Čo všetko zahŕňajú inovácie? Hovoríme iba o inováciach liekov?

Nie. Ako som spomenula vyššie, ide aj o ďalšie inovácie, ktoré zlepšujú diagnostickú prácu a liečebný proces. To znamená, že do inovácií nie je zahrnutý iba liek, ale aj liečebný postup, alebo nová diagnostická metóda. V dnešnej dobe nastal boom zdravotníckych pomôcok, a tie dokážu uľahčiť život mnohým ľuďom. Pod zdravotníckymi pomôckami si môžeme predstaviť napríklad kardiostimulátor, alebo aj elektronické protézy. 

Kde nás najviac tlačí topánka, čo sa týka klinického skúšania v SR? 

Hoc máme legislatívu vcelku dobre nastavenú, za ostatných 11 rokov neexistoval žiaden vykonávací predpis, ktorý by širokej odbornej verejnosti, hlavne na strane etických komisií a zadávateľov, ujednotil pravidlá. Preto na Slovensku každá etická komisia vykladá zákon v rámci svojich možností, a každý zadávateľ postupuje pri žiadostiach podľa svojho výkladu. Preto je schvaľovací proces veľmi pomalý. V prípade, že by bol pomalý, pretože sa dáva zreteľ na kvalitatívnu stránku, tak si poviem, že je to v poriadku. Ale u nás je problém hlavne z administratívnej stránky. Pevne verím, že nové nariadenie EÚ 536/2014 rozhýbe náš legislatívny systém, a dôjde k uniformite posudzovania klinického skúšania na Slovenku.

Lekári museli vždy postupovať podľa zásad správnej klinickej praxe. Zároveň ma mrzí, že na strane legislatívcov, obecne celý farmaceutický priemysel je braný ako netransparentný biznis, hoc počas inovácie (za marketing, to neviem posúdiť), sú tak prísne nastavené medzinárodné pravidlá, že ku korupcii alebo netransparentnosti nemôže dôjsť. Práca našich lekárov je niekoľkokrát ročne kontrolovaná medzinárodnými auditmi, a každý lekár dostáva odpoveď na to, čo má vo svojej práci zlepšiť. 

Do dnešného dňa, som nikde nevidela oficiálne údaje, koľko ušetrí verejné zdravotníctvo z účasti na klinickom skúšaní. Preto som rada, že na našu konferenciu prijala pozvanie aj zdravotná poisťovňa – s prísľubom, že túto úsporu sa pokúsia vyčísliť. Aj preto sa teším na našu konferenciu Transparentnosť klinického skúšania.

Znamená to, že čím je viac informácií, tým je väčší pokrok v inováciách?

Jasné, o tom niet pochýb. Ak si štát uvedomí, že klinické skúšania sú prospešné nielen pre účastníka skúšania, ale aj pre štát, bude to super. Taktiež, ak by AIFP dokázalo vyčísliť, koľko ľudí priamo, ale aj nepriamo (prekladatelia, personál, nižší zdravotnícky personál, laboratóriá, kuriérne služby...), je zamestnaných týmto spôsobom, možno by sme boli všetci prekvapení. Táto oblasť by sa stala zaujímavejšou pre všetkých, bez obviňovania a očierňovania…

Aj keď, o legálnosti klinického skúšania, sa možno informovať tak na medzinárodných stránkach, ako aj priamo na príslušnej etickej komisii, či na ŠÚKL.

Preto – čím viac máme informácií, tým sa posúvame ďalej a rýchlejšie. No hoci ide o výskum, niektoré dáta musia byť chránené tak, aby nedošlo k nekalej konkurencii, alebo ukradnutiu… Musia existovať aj pravidlá na ochranu údajov. To nám na našej konferencii pokryje Úrad pre ochranu osobných údajov.

Aký význam majú inovácie a klinické skúšania pre všetkých pacientov?

Obrovský. Včasná a dobrá diagnostika zvyšuje možnosť liečby, a s tým súvisí aj kvalita života. Inováciami získavame informácie, ako lepšie, rýchlejšie a bezpečnejšie liečiť. Treba si uvedomiť, že klinické skúšanie je neštandardná terapia/diagnostika – je to stále výskum. Podlieha prísnej kontrole, aby bola bezpečnosť účastníka čo najviac garantovaná. To je zabezpečené pravidelným monitorovaním účastníka a štatistickým spracovaním dát.

Každý účastník by sa mal ku klinickému skúšaniu postaviť tak, že pre niekoho to môže znamenať nádej, no nikomu nemôže lekár sľúbiť vyliečenie. Počas klinického skúšania ide hlavne o zistenie bezpečnosti a účinnosti lieku na dostačnom počte účastníkov – tak, aby sa (po registrácií) dostal na trh čo najbezpečnejší a naúčinnejší liek.





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