{"id":918,"date":"2013-01-02T17:26:26","date_gmt":"2013-01-02T15:26:26","guid":{"rendered":"http:\/\/slanedeti.sk\/cms\/klinicke-studie-co-by-mal-pacient-vediet-ii-cast-2\/201301"},"modified":"2014-01-01T12:46:56","modified_gmt":"2014-01-01T11:46:56","slug":"klinicke-studie-co-by-mal-pacient-vediet-ii-cast-2","status":"publish","type":"post","link":"https:\/\/slanedeti.sk\/cms\/klinicke-studie-co-by-mal-pacient-vediet-ii-cast-2\/918","title":{"rendered":"Klinick\u00e9 \u0161t\u00fadie: \u010co by mal pacient vedie\u0165 &#8211; II. \u010das\u0165"},"content":{"rendered":"<p>V\u00fdvoj nov\u00fdch liekov prech\u00e1dza v poslednom obdob\u00ed ur\u010dit\u00fdmi zmenami. Ve\u013ek\u00e9 medzin\u00e1rodn\u00e9 farmaceutick\u00e9 firmy priniesli v poslednom obdob\u00ed na trh men\u0161\u00ed po\u010det nov\u00fdch lie\u010div. V s\u00fa\u010dastnosti t\u00fdmto firm\u00e1m kon\u010dia ochrann\u00e9 doby, po ktorej m\u00f4\u017ee lie\u010divo vyr\u00e1ba\u0165 generick\u00e1 firma. Preto v s\u00fa\u010dastnosti rastie najm\u00e4 generick\u00fd trh a tie\u017e men\u0161ie biotechnologick\u00e9 firmy, ktor\u00e9 zd\u00e1 sa, boli produkt\u00edvnej\u0161ie vo v\u00fdvoji nov\u00fdch molek\u00fal. Z\u00e1rove\u0148 vzrast\u00e1 v\u00fdznam outsourcingu, rast CRO a biotechnologick\u00e9ho sektora sa vz\u00e1jomne podporuj\u00fa.<\/p>\n<h4>Trendy vo v\u00fdvoji lie\u010div<\/h4>\n<p>Zd\u00e1 sa \u017ee regula\u010dn\u00e9 \u00farady (ako FDA) s\u00fa teraz viac predmetom z\u00e1ujmu verejnosti. To bolo vyvolan\u00e9 najm\u00e4 pr\u00edpadmi stiahnut\u00edm niektor\u00fdch liekov (Vioxx, Lipobay) a nespr\u00e1vne veden\u00fdmi \u0161t\u00fadiami (TGN1412). Preto tieto \u00farady sk\u00f4r spr\u00edsnili predpisy pre v\u00fdvoj nov\u00fdch liekov s cie\u013eom \u00faplne vyl\u00fa\u010di\u0165 mo\u017enos\u0165 zopakovania sa podobn\u00fdch probl\u00e9mov. Tento pr\u00edstup sa stal ter\u010dom kritiky farmaceutick\u00e9ho priemyslu, ked\u017ee \u010falej s\u0165a\u017euje v\u00fdvoj nov\u00fdch liekov. Vyspel\u00e9 krajiny prijali e\u0161te v 80-tych rokoch predpisy podporuj\u00face v\u00fdvoj liekov na zriedkav\u00e9 ochorenia (orphan designation). To umo\u017enilo prinies\u0165 na trh, alebo do pokro\u010dil\u00e9ho \u0161t\u00e1dia v\u00fdvoja tie\u017e lieky, ktor\u00e9 by mali men\u0161iu \u0161ancu uspe\u0165 na trhu kv\u00f4li n\u00edzkemu po\u010dtu pacientov.<\/p>\n<div style=\"text-align: center;\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter\" style=\"border: 0px; margin-top: 20px; margin-bottom: 20px;\" title=\"201301021736_klinicka_studia2\" alt=\"201301021736_klinicka_studia2\" src=\"https:\/\/slanedeti.sk\/cms\/picture_migration\/201301021736_klinicka_studia2.jpg\" width=\"400\" height=\"296\" border=\"0\" \/><\/div>\n<p>Medzin\u00e1rodn\u00e9 farmaceutick\u00e9 spolo\u010dnosti objavili stredn\u00fa Eur\u00f3pu ako vhodn\u00e9 miesto pre klinick\u00e9 \u0161t\u00fadie v druhej polovici 90-tych rokov a po\u010det \u0161t\u00fadii tu odvtedy rastie. Ni\u017e\u0161ie n\u00e1klady s\u00fa jednozna\u010dne najd\u00f4le\u017eitej\u0161\u00edm faktorom, ktor\u00fd ich k tomu motivuje. Najm\u00e4 platy lek\u00e1rov s\u00fa v strednej Eur\u00f3pe v\u00fdrazne ni\u017e\u0161ie oproti z\u00e1padu. Zad\u00e1vate\u013eia platia pribli\u017ene rovnak\u00e9 odmeny lek\u00e1rom v z\u00e1padnej aj strednej Eur\u00f3pe ale vzhladom na ni\u017e\u0161ie platy je motiv\u00e1cia pre pr\u00e1cu na \u0161t\u00fadi\u00e1ch vy\u0161\u0161ia. \u010eal\u0161\u00edm faktorom je aj \u013eah\u0161\u00ed n\u00e1bor pacientov. Pacienti v strednej Eur\u00f3pe maj\u00fa v\u00e4\u010d\u0161iu d\u00f4veru v odpor\u00fa\u010dania lek\u00e1ra, vr\u00e1tane z\u00fa\u010dastnennia sa klinickej \u0161t\u00fadie. V\u00e4\u010d\u0161ou motiv\u00e1ciou pre pacientov m\u00f4\u017ee by\u0165 aj pr\u00edstup k modern\u00fdm liekom. Aj bez oh\u013eadu na tieto faktory farmaceutick\u00e9 firmy maj\u00fa \u010fal\u0161ie d\u00f4vody h\u013eadat \u010fal\u0161\u00edch pacientov, ktor\u00fdch je v z\u00e1padnej Eur\u00f3pe \u010dasto nedostatok. S\u00fa to nov\u00e9 predpisy pre \u0161t\u00fadie ktor\u00e9 vy\u017eaduj\u00fa v\u00e4\u010d\u0161ie s\u00fabory pacientov a v\u00e4\u010d\u0161iu genetick\u00fa rozmanitos\u0165 aby mohli by\u0165 zaregistrovan\u00e9 aj ve\u013emi zriedkav\u00e9 ne\u017eiad\u00face \u00fa\u010dinky resp. tak\u00e9 ktor\u00e9 sa via\u017eu na v\u00fdskyt m\u00e1lo roz\u0161\u00edren\u00fdch genetick\u00fdch odchyliek. K dobr\u00e9mu menu strednej Eur\u00f3py v klinick\u00fdch \u0161t\u00fadi\u00e1ch prispievaj\u00fa aj v\u00fdsledky medin\u00e1rodn\u00fdch auditov (FDA), ktor\u00e9 s\u00fa \u010dasto lep\u0161ie ako v z\u00e1padnej Eur\u00f3pe a USA. Z rovnak\u00fdch d\u00f4vodov ako v strednej Eur\u00f3pe sa zvy\u0161uje po\u010det \u0161t\u00fadii v da\u013e\u0161\u00edch krajin\u00e1ch, najm\u00e4 v Latinskej Amerike a Indii kde je rast v s\u00fa\u010dastnosti najr\u00fdchlej\u0161\u00ed.<\/p>\n<p style=\"text-align: center;\">Po\u010det klinick\u00fdch \u0161t\u00fadii v strednej a v\u00fdchodnej Eur\u00f3pe, f\u00e1zy I \u2013 III, 2009<\/p>\n<p style=\"text-align: center;\"><a href=\"http:\/\/www.outsourcing-pharma.com\/\">http:\/\/www.outsourcing-pharma.com<\/a><br \/>\n<img loading=\"lazy\" decoding=\"async\" class=\"aligncenter\" style=\"border: 0px; margin-top: 20px; margin-bottom: 20px;\" title=\"201301021736_klinicka_studia3\" alt=\"201301021736_klinicka_studia3\" src=\"https:\/\/slanedeti.sk\/cms\/picture_migration\/201301021736_klinicka_studia3.png\" width=\"450\" height=\"259\" border=\"0\" \/><\/p>\n<p>&nbsp;<\/p>\n<h4><strong>Najd\u00f4le\u017eitej\u0161ie inform\u00e1cie pre pacienta vstupuj\u00faceho do klinickej \u0161t\u00fadie<\/strong><\/h4>\n<h4><strong>Ak\u00e9 s\u00fa pr\u00e1va pacienta v klinickej \u0161t\u00fadii?<\/strong><\/h4>\n<p>Podrobne s\u00fa op\u00edsan\u00e9 v pr\u00e1vnych predpisoch upravuj\u00facich priebeh klinick\u00fdch \u0161t\u00fadii (zoznam pod Ako s\u00fa klinick\u00e9 \u0161t\u00fadie regulovan\u00e9).<br \/>\nZ\u00e1kladn\u00e9 pr\u00e1va \u00fa\u010dastn\u00edka klinickej \u0161t\u00fadie s\u00fa:<\/p>\n<ul>\n<li>By\u0165 informovan\u00fd o cie\u013eoch klinick\u00e9ho sk\u00fa\u0161ania, o mo\u017enom pr\u00ednose, rizik\u00e1ch a nev\u00fdhod\u00e1ch klinick\u00e9ho sk\u00fa\u0161ania, in\u00fdch mo\u017enostiach lie\u010dby<\/li>\n<li>Odmietn\u00fa\u0165 \u00fa\u010dast na \u0161t\u00fadii pri\u010dom nem\u00f4\u017ee by\u0165 v d\u00f4sledku odmietnutia vystaven\u00fd ak\u00fdmkolvek nepriazniv\u00fdm n\u00e1sledkom tohto rozhodnutia<\/li>\n<li>Kedyko\u013evek zo \u0161t\u00fadie vyst\u00fapi\u0165 pri\u010dom nemus\u00ed uvies\u0165 d\u00f4vod rozhodnutia<\/li>\n<li>Pr\u00e1vo na ochranu osobn\u00fdch \u00fadajov \u2013 \u017eiadne vedeck\u00e9 \u00fadaje \u00fadaje nem\u00f4\u017eu by\u0165 uchov\u00e1van\u00e9 tak aby umo\u017enili identifik\u00e1ciu pacienta, \u00fa\u010das\u0165 v \u0161t\u00fadii je d\u00f4vern\u00e1<\/li>\n<\/ul>\n<h4><strong>Ak\u00fd prospech m\u00f4\u017ee pacient z\u00edska\u0165 \u00fa\u010das\u0165ou na klinickej \u0161t\u00fadii?<\/strong><\/h4>\n<ul>\n<li>Najv\u00fdznamnej\u0161\u00ed je terapeutick\u00fd prospech \u2013 pacient je lie\u010den\u00fd najmodernej\u0161\u00edmi liekmi, ktor\u00e9 e\u0161te nie s\u00fa nijak inak dostupn\u00e9 a m\u00f4\u017ee o\u010dak\u00e1va\u0165 zlep\u0161enie zdravotn\u00e9ho stavu. Okrem sk\u00faman\u00e9ho lie\u010diva je pacient tie\u017e d\u00f4slednej\u0161ie sledovan\u00fd a m\u00f4\u017ee absolvova\u0165 vy\u0161etrenia, ktor\u00e9 sa be\u017ene alebo v takom rozsahu nerobia a m\u00f4\u017eu prispie\u0165 k optimaliz\u00e1cii lie\u010dby.<\/li>\n<li>Materi\u00e1lny prospech pacienta je pr\u00e1vnymi predpismi v\u00fdrazne obmedzen\u00fd. Priame finan\u010dn\u00e9 odme\u0148ovanie nie je povolen\u00e9. Je ale akceptovan\u00e9, \u017ee pacient by nemal ma\u0165 v s\u00favislosti so \u0161t\u00fadiou \u017eiadne finan\u010dn\u00e9 v\u00fddavky \u2013 cestovn\u00e9 n\u00e1klady s\u00fa spravidla preplaten\u00e9. Drobn\u00e9 dary (ako napr. ta\u0161ka, hra\u010dky pre deti) s\u00fa povolen\u00e9. V\u00e4\u010d\u0161ina pacientov nie je teda za \u00fa\u010das\u0165 v klinick\u00fdch \u0161t\u00fadi\u00e1ch finan\u010dne honorovan\u00e1, v niektor\u00fdch pr\u00edpadoch ale zad\u00e1vatelia na\u0161li medzery v predpisoch a finan\u010dne odme\u0148uj\u00fa pacientov za \u00fa\u010das\u0165.<\/li>\n<li>Pacient \u00fa\u010das\u0165ou na \u0161t\u00fadii prispieva k medic\u00ednskemu pokroku z ktor\u00e9ho m\u00f4\u017ee profitova\u0165 ke\u010f sa sk\u00faman\u00e9 lieky v\u010faka \u00faspe\u0161n\u00fdm \u0161t\u00fadi\u00e1m dostan\u00fa na trh.<\/li>\n<\/ul>\n<h4><strong>Ak\u00e9 s\u00fa nev\u00fdhody a rizik\u00e1 \u00fa\u010dasti na klinickej \u0161t\u00fadii?<\/strong><\/h4>\n<ul>\n<li>Klinick\u00e9 \u0161t\u00fadie s\u00fa \u010dasto randomizovan\u00e9 &#8211; \u010das\u0165 pacientov nedost\u00e1va sk\u00fa\u0161an\u00e9 lie\u010divo ale placebo. Na tomto z\u00e1klade m\u00f4\u017eu vznikn\u00fa\u0165 obavy, \u017ee pacient nie je dostato\u010dne lie\u010den\u00fd. Predpisy a \u0161tandardy klinick\u00fdch \u0161t\u00fadii maj\u00fa za cie\u013e v prvom rade zaru\u010di\u0165 prospech pacienta. Preto je dizajn \u0161t\u00fadie zvolen\u00fd v\u017edy tak aby absencia lie\u010diva nemohla zapr\u00ed\u010dini\u0165 v\u00e1\u017enej\u0161ie zhor\u0161enie zdravotn\u00e9ho stavu. Pri \u0161t\u00fadi\u00e1ch, pri ktor\u00fdch by absencia lie\u010dby mala negat\u00edvne d\u00f4sledky, sa ako kontrola nepou\u017e\u00edva placebo ale \u0161tandardn\u00e9 lie\u010divo pre dan\u00fa indik\u00e1ciu.<\/li>\n<li>Sk\u00fa\u0161an\u00e9 lie\u010divo nie je nato\u013eko dobre pre\u0161tudovn\u00e9 ako registrovan\u00e9 lieky. Je v\u00e4\u010d\u0161ia pravdepodonos\u0165 v\u00fdskytu ne\u010dakan\u00fdch ne\u017eiad\u00facich \u00fa\u010dinkov, pr\u00edpadne zlyhania terapeutick\u00e9ho \u00fa\u010dinku. Pacient by si mal ale z\u00e1rove\u0148 uvedomi\u0165, \u017ee pred t\u00fdm ako mu je lie\u010divo podan\u00e9 bolo podroben\u00e9 rozsiahlemu \u0161t\u00fadiu bezpe\u010dnosti, \u010di u\u017e na zvierat\u00e1ch alebo v skor\u0161\u00edch f\u00e1zach klinick\u00e9ho sk\u00fa\u0161ania. Pr\u00edpady z\u00e1va\u017en\u00fdch ne\u017eiad\u00facich \u00fa\u010dinkov alebo \u00famrtia v s\u00favislosti s podan\u00edm sk\u00fa\u0161an\u00e9ho lie\u010diva s\u00fa ve\u013emi zriedkav\u00e9. Pacient je povinne poisten\u00fd (poistenie plat\u00ed zad\u00e1vate\u013e) pre pr\u00edpad po\u0161kodenia zdravia.<\/li>\n<li>Klinick\u00e1 \u0161t\u00fadia si od pacienta vy\u017eaduje ur\u010dit\u00e9 n\u00e1roky, ktor\u00e9 mus\u00ed dodr\u017ea\u0165. Tie m\u00f4\u017eu zah\u0155\u0148a\u0165 napr\u00edklad kontroln\u00e9 n\u00e1v\u0161tevy u lek\u00e1ra (v niektor\u00fdch pr\u00edpadoch s\u00fa to iba n\u00e1v\u0161tevy, ktor\u00e9 by pacient aj tak absolvoval ako be\u017en\u00e9 kontroly), podrobi\u0165 sa dal\u0161\u00edm vy\u0161etreniam, pobyt v nemocnici, u\u017e\u00edva\u0165 sk\u00fa\u0161an\u00e9 lie\u010divo pod\u013ea sch\u00e9my ur\u010denej lek\u00e1rom, \u010diasto\u010dn\u00e1 \u00faprava denn\u00e9ho re\u017eimu a aktiv\u00edt (ako napr. predp\u00edsan\u00e9 cvi\u010denie)<\/li>\n<\/ul>\n<h4><strong>Ak\u00fd je pre pacienta typick\u00fd priebeh klinickej \u0161t\u00fadie?<\/strong><\/h4>\n<p><strong><\/strong>Priebeh ka\u017edej klinickej \u0161t\u00fadie je odli\u0161n\u00fd. V\u0161etky vy\u0161etrenia, d\u00e1vkovanie lie\u010diva s\u00fa stanoven\u00e9 tak aby nap\u013a\u0148ali ciele \u0161t\u00fadie a s\u00fa podrobne pop\u00edsan\u00e9 v protokole \u0161t\u00fadie. Lek\u00e1r by mal informova\u0165 pacienta ako bude \u0161t\u00fadia prebieha\u0165 a \u010do si bude vy\u017eadova\u0165. Tieto inform\u00e1cie musia by\u0165 obsiahnut\u00e9 aj v informovanom s\u00fahlase.<\/p>\n<p>Pred vstupom do \u0161t\u00fadie mus\u00ed pacient podp\u00edsa\u0165 informovan\u00fd s\u00fahlas \u2013 dokument, ktor\u00fd ho obozn\u00e1mi s jeho pr\u00e1vami a so \u0161t\u00fadiou ktorej sa pl\u00e1nuje z\u00fa\u010dastni\u0165 a z\u00e1rove\u0148 potvrd\u00ed svoju v\u00f4lu z\u00fa\u010dastni\u0165 sa \u0161t\u00fadie. V pr\u00edpade det\u00ed podpisuje informovan\u00fd s\u00fahlas rodi\u010d ale die\u0165a m\u00e1 by\u0165 takisto pou\u010den\u00e9 o \u0161t\u00fadii. Pred podpisom informovan\u00e9ho s\u00fahlasu resp. zaradenia do \u0161t\u00fadie by lek\u00e1r \u010di pacient nemal podnika\u0165 \u017eiadne kroky v s\u00falade so z\u00e1mermi klinickej \u0161t\u00fadie (ako napr. \u00faprava medik\u00e1cie). \u00da\u010delom vstupnej n\u00e1v\u0161tevy je zisti\u0165 \u010di pacient sp\u013a\u0148a podmienky na zaradenie do klinickej \u0161t\u00fadie (ako napr. predp\u00edsan\u00e9 hodnoty laborat\u00f3rnych parametrov, vit\u00e1lnej kapacity pl\u00fac resp. in\u00fdch pod\u013ea protokolu). Pri placebom kontrolovan\u00fdch \u0161t\u00fadi\u00e1ch s\u00fa pacienti po zaraden\u00ed do \u0161t\u00fadie n\u00e1hodne rozdelen\u00ed do skup\u00edn, pri\u010dom jedna dost\u00e1va sk\u00fa\u0161an\u00fd liek a druh\u00e1 placebo (randomiz\u00e1cia). Rozdelenie nerob\u00ed lek\u00e1r a je n\u00e1hodn\u00e9, aby sa zaru\u010dila nezaujatos\u0165 pri posudzovan\u00ed \u00fa\u010dinku sk\u00faman\u00e9ho lieku.<\/p>\n<p>N\u00e1sledne je spravidla pacientovi podan\u00e9 sk\u00fa\u0161an\u00e9 lie\u010divo\/placebo, je obozn\u00e1men\u00fd s podrobnos\u0165ami d\u00e1vkovac\u00edeho re\u017eimu, pl\u00e1nom kontrol pri ktor\u00fdch sa bude vyhodnocova\u0165 vplyv sk\u00fa\u0161an\u00e9ho lie\u010diva\/placeba na jeho zdravotn\u00fd stav. D\u013a\u017eka \u0161t\u00fadie b\u00fdva ve\u013emi variabiln\u00e1 \u2013 od nieko\u013eko dn\u00ed po roky. Niektor\u00e9 \u0161t\u00fadie si vy\u017eaduj\u00fa tie\u017e pobyt v nemocnici. Odber vzoriek (mo\u010d, krv) s\u00fa be\u017en\u00e9, rovnako ako aj \u010fal\u0161ie diagnostick\u00e9 vy\u0161etrenia (CT, &#8230; ). Klinick\u00e1 \u0161t\u00fadia m\u00f4\u017ee by\u0165 roz\u0161\u00edren\u00e1 aj o parametre, ktor\u00e9 sa net\u00fdkaj\u00fa v\u00fdlu\u010dne farmakol\u00f3gie ako napr\u00edklad farmakogenetick\u00fd v\u00fdskum. Pr\u00edkladom m\u00f4\u017ee by\u0165 sledovanie ak\u00fd vplyv maj\u00fa g\u00e9ny pacienta na vylu\u010dovanie lieku alebo vplyv g\u00e9nov na \u00fa\u010dinok liekov pri ochoreniach, ktor\u00e9 s\u00fa \u010diasto\u010dne geneticky podmienen\u00e9 (ako napr. rakovina). Pri farmakogenetickom vy\u0161etren\u00ed sa odoberie krv a analyzuje sa DNA pacienta. \u010eal\u0161\u00edm pomerne roz\u0161\u00edren\u00fdm sledovan\u00edm je kvalita \u017eivota ktor\u00e1 sa sleduje dotazn\u00edkom a sna\u017e\u00ed sa zisti\u0165 efekt lie\u010dby ako ju subjekt\u00edvne hodnot\u00ed pacient. Za ist\u00fdch okolnost\u00ed m\u00f4\u017ee lek\u00e1r rozhodn\u00fa\u0165 o vyraden\u00ed pacienta z klinickej \u0161t\u00fadie. D\u00f4vodom pre vyradenie m\u00f4\u017ee by\u0165 najm\u00e4 zhor\u0161enie zdravotn\u00e9ho stavu.<\/p>\n<p>Po skon\u010den\u00ed \u0161t\u00fadie je dokument\u00e1cia archivovan\u00e1 pod\u013ea z\u00e1kona minim\u00e1lne 15 rokov. Vedeck\u00e9 \u00fadaje z\u00edskan\u00e9 pri \u0161t\u00fadii s\u00fa odovzdan\u00e9 zad\u00e1vate\u013eovi, ktor\u00fd ich vyhodnot\u00ed. S\u00fahrnn\u00e9 \u00fadaje s vyvoden\u00fdmi z\u00e1vermi o \u00fa\u010dinku sk\u00fa\u0161an\u00e9ho lieku m\u00f4\u017eu by\u0165 publikovan\u00e9 vo vedeck\u00fdch \u010dasopisoch. V pr\u00edpade \u017ee sa liek preuk\u00e1\u017ee by\u0165 \u00fa\u010dinn\u00fd a bezpe\u010dn\u00fd s\u00fa v\u00fdsledky klinick\u00fdch \u0161t\u00fadii predlo\u017een\u00e9 ako s\u00fa\u010das\u0165 registra\u010dnej dokument\u00e1cie pre z\u00edskanie povolenia na uvedenie lieku na trh.<\/p>\n<h4><strong>Ako sa pacient mo\u017ee prihl\u00e1si\u0165 do klinickej \u0161t\u00fadie?<\/strong><\/h4>\n<p><strong><\/strong>Vo v\u00e4\u010d\u0161ine pr\u00edpadov pon\u00fakne pacientovi \u00fa\u010das\u0165 na \u0161t\u00fadii lek\u00e1r. Najm\u00e4 vo vyspel\u00fdch krajin\u00e1ch s\u00fa akt\u00edvnej\u0161\u00ed pri hladan\u00ed pacientov aj zad\u00e1vatelia \u0161t\u00fadii (farmaceutcik\u00e9 firmy). Pacient m\u00f4\u017ee samozrejme oslovi\u0165 lek\u00e1ra alebo farmaceutick\u00fa firmu so \u017eiado\u0165ou by\u0165 zaraden\u00fd do \u0161t\u00fadie &#8211; ak pr\u00e1ve prebieha a naber\u00e1 pacientov. Pacient bude ale zaraden\u00fd iba ak sp\u013a\u0148a podmienky pre zaradenie \u2013 definovan\u00e9 protokolom \u0161t\u00fadie vz\u0165ahuj\u00face sa k zdravotn\u00e9mu stavu. Okrem toho m\u00f4\u017ee lek\u00e1r odmietnu\u0165 zaradi\u0165 pacienta aj z in\u00fdch d\u00f4vodov \u2013 napr\u00edklad ke\u010f o\u010dak\u00e1va od pacienta slab\u00fa spolupr\u00e1cu.<\/p>\n<p>Najjednoduch\u0161\u00edm sp\u00f4sobom ako n\u00e1js\u0165 klinick\u00fa \u0161t\u00fadiu je pou\u017eitie internetov\u00fdch datab\u00e1z. Najkomplexnej\u0161ou datab\u00e1zou klinick\u00fdch \u0161t\u00fadii je <a href=\"http:\/\/www.clinicaltrials.gov\/\">http:\/\/www.clinicaltrials.gov<\/a> zriaden\u00e1 U.S National Institutes of Health. \u017diaden medzin\u00e1rodn\u00fd pr\u00e1vny predpis nebr\u00e1ni \u00fa\u010dasti pacienta na \u0161t\u00fadii v inej krajine ale naopak niektor\u00e9 krajiny obmedzuj\u00fa \u00fa\u010das\u0165 cudzincov na \u0161t\u00fadi\u00e1ch. \u00da\u010das\u0165 pacientov z viacer\u00fdch kraj\u00edn je v pr\u00edpade ve\u013emi zriedkav\u00fdch ochoren\u00ed nevyhnutn\u00e1 \u2013 ked\u017ee v jednej krajine nemus\u00ed by\u0165 dostatok pacientov. Pri niektor\u00fdch chronick\u00fdch ochoreniach s\u00fa pomerne \u010dast\u00e9 da\u013e\u0161ie \u2013 sekund\u00e1ne po\u0161kodenia (napr\u00edklad ako po\u0161kodenie zraku pri diabete). Preto niekedy prich\u00e1dza do \u00favahy pre pacienta aj \u00fa\u010das\u0165 vo viacer\u00fdch \u0161t\u00fadi\u00e1ch ale na druhej strane protokol \u0161t\u00fadie \u010dasto tak\u00e9to mo\u017enosti obmedzuje a stanovuje, \u017ee pacient by nemal ma\u0165 in\u00e9 z\u00e1va\u017en\u00e9 ochorenie. D\u00f4vodom je najm\u00e4 z\u00edskanie koherentn\u00fdch \u00fadajov o \u00fa\u010dinku lieku tak aby neboli ovplyvnen\u00e9 in\u00fdmi faktormi.<\/p>\n<p>Za ist\u00fdch v\u00fdnimo\u010dn\u00fdch okolnost\u00ed m\u00f4\u017ee by\u0165 sk\u00fa\u0161an\u00fd liek podan\u00fd aj pacientovi ktor\u00fd sa nez\u00fa\u010dast\u0148uje \u0161t\u00fadie, pri\u010dom mot\u00edvom jeho podania je prepoklad zlep\u0161enia jeho zdravotn\u00e9ho stavu. Toto podanie si tie\u017e vy\u017eaduje s\u00fahlas zad\u00e1vatela a ozna\u010duje sa ako \u201ccompassionate use\u201d. Pou\u017eitie neregistrovan\u00fdch liekov pri \u201ccompassionate use\u201d upravuje Compassionate Use Guideline od EMEA.<\/p>\n<h4><strong>Ako s\u00fa klinick\u00e9 \u0161t\u00fadie regulovan\u00e9?<\/strong><\/h4>\n<p><strong><\/strong>Pred t\u00fdm ako sa za\u010dne, ka\u017ed\u00e1 klinick\u00e1 \u0161t\u00fadia podlieha schv\u00e1leniu kontroln\u00fdm \u00faradom &#8211; na Slovensku je to \u0160t\u00e1tny \u00fastav pre kontrolu lie\u010div. Na Eur\u00f3pskej \u00farovni je kompetentn\u00fdm \u00faradom European Medicines Agency (EMEA) a v USA Food and Drug Administration (FDA). Okrem toho ka\u017ed\u00e1 klinick\u00e1 \u0161t\u00fadia mus\u00ed by\u0165 schv\u00e1len\u00e1 minim\u00e1lne jednou etickou komisiou v ktorej p\u00f4sobnosti je zdravotn\u00edcke pracovisko kde \u0161t\u00fadia prebieha. Pod\u013ea z\u00e1kona Etick\u00e1 komisia rie\u0161i ot\u00e1zky vznikaj\u00face pri zdravotnej starostlivosti a etick\u00fa prijate\u013enos\u0165 projektov biomedic\u00ednskeho v\u00fdskumu. \u010clenmi etickej komisie zo z\u00e1kona musia by\u0165 aj osoby bez (zdravotn\u00edckej) odbornej sp\u00f4sobilosti. \u010clenmi teda m\u00f4\u017eu by\u0165 napr\u00edklad z\u00e1stupcovia pacientsk\u00fdch organiz\u00e1cii, \u010d\u00edm z\u00edskavaj\u00fa mo\u017enos\u0165 by\u0165 partnerom a vyjadrova\u0165 svoje pripomienky ku klinick\u00e9mu v\u00fdskumu. T\u00fato mo\u017enos\u0165 zatia\u013e pacientske organiz\u00e1cie na Slovensku pr\u00edli\u0161 nevyu\u017e\u00edvaj\u00fa.<\/p>\n<p>Normat\u00edvne z\u00e1klady vykon\u00e1vania klinick\u00e9ho v\u00fdskumu:<\/p>\n<ul>\n<li>Helsinsk\u00e1 deklar\u00e1cia (1964 a n\u00e1sledn\u00e9 rev\u00edzie) \u2013 pr\u00e1vne nez\u00e1v\u00e4zn\u00fd ale v\u0161eobecne akceptovan\u00fd dokument definuj\u00faci etick\u00e9 princ\u00edpy medic\u00ednskeho v\u00fdskumu na ktorom sa z\u00fa\u010dast\u0148uj\u00fa \u013eudia<\/li>\n<li>Directive 2001\/83\/EC on the Community code relating to medicinal products for human use<\/li>\n<li>Directive 2001\/20\/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use<\/li>\n<li>V\u0161eobecne uzn\u00e1van\u00e9 technick\u00e9 predpisy vz\u0165ahuj\u00face sa k vykon\u00e1vaniu klinick\u00fdch \u0161t\u00fadii boli vypracovan\u00e9 International Conference on Harmonisation<\/li>\n<li>Eur\u00f3pska legislat\u00edva je aproximovan\u00e1 v Slovensk\u00fdch pr\u00e1vnych predpisoch:<\/li>\n<li>Z\u00e1kon 362\/2011 o liekoch a zdravotn\u00edckych pom\u00f4ckach v znen\u00ed neskor\u0161\u00edch predpisov<\/li>\n<li>Z\u00e1kon 576\/2004 o zdravotnej starostlivosti, slu\u017eb\u00e1ch s\u00favisiacich s poskytovan\u00edm zdravotnej starostlivosti<\/li>\n<li>Vyhl\u00e1\u0161ka MZ SR 433\/2011 o po\u017eiadavk\u00e1ch na klinick\u00e9 sk\u00fa\u0161anie a spr\u00e1vnu klinick\u00fa prax<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>V&yacute;voj nov&yacute;ch liekov prech&aacute;dza v poslednom obdob&iacute; ur&#269;it&yacute;mi zmenami. Ve&#318;k&eacute; medzin&aacute;rodn&eacute; farmaceutick&eacute; firmy priniesli v poslednom obdob&iacute; na trh men&scaron;&iacute; po&#269;et nov&yacute;ch lie&#269;iv. V s&uacute;&#269;astnosti t&yacute;mto firm&aacute;m kon&#269;ia ochrann&eacute; doby, po ktorej m&ocirc;&#382;e lie&#269;ivo vyr&aacute;ba&#357; generick&aacute; firma. Preto v s&uacute;&#269;astnosti &hellip; <a href=\"https:\/\/slanedeti.sk\/cms\/klinicke-studie-co-by-mal-pacient-vediet-ii-cast-2\/918\">Continued<\/a><\/p>\n","protected":false},"author":7,"featured_media":1105,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"kt_blocks_editor_width":"","footnotes":""},"categories":[3],"tags":[231,210],"class_list":["post-918","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-lieky-a-liecba","tag-klinicka-studia","tag-lieky"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Klinick\u00e9 \u0161t\u00fadie: \u010co by mal pacient vedie\u0165 - II. \u010das\u0165 - Slan\u00e9 deti<\/title>\n<meta name=\"description\" content=\"Ak\u00e9 s\u00fa pr\u00e1va pacienta v klinickej \u0161t\u00fadii, ak\u00fd prospech m\u00f4\u017ee z\u00edska\u0165, ak\u00e9 s\u00fa nev\u00fdhody a rizik\u00e1, ak\u00fd je typick\u00fd priebeh klinickej \u0161t\u00fadie?\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/slanedeti.sk\/cms\/klinicke-studie-co-by-mal-pacient-vediet-ii-cast-2\/918\" \/>\n<meta property=\"og:locale\" content=\"sk_SK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Klinick\u00e9 \u0161t\u00fadie: \u010co by mal pacient vedie\u0165 - 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