{"id":917,"date":"2012-12-06T21:07:40","date_gmt":"2012-12-06T19:07:40","guid":{"rendered":"http:\/\/slanedeti.sk\/cms\/klinicke-studie-co-by-mal-pacient-vediet-i-cast-2\/201212"},"modified":"2014-01-01T12:55:06","modified_gmt":"2014-01-01T11:55:06","slug":"klinicke-studie-co-by-mal-pacient-vediet-i-cast-2","status":"publish","type":"post","link":"https:\/\/slanedeti.sk\/cms\/klinicke-studie-co-by-mal-pacient-vediet-i-cast-2\/917","title":{"rendered":"Klinick\u00e9 \u0161t\u00fadie: \u010co by mal pacient vedie\u0165 &#8211; I. \u010das\u0165"},"content":{"rendered":"<p>Klinick\u00e1 \u0161t\u00fadia je pokro\u010dilou f\u00e1zou v\u00fdvoja nov\u00e9ho lieku, ke\u010f sa sk\u00fa\u0161obne pod\u00e1va \u013eudom. Klinick\u00fa \u0161t\u00fadiu je nevyhnutn\u00e9 vykona\u0165 takmer pri v\u0161etk\u00fdch nov\u00fdch liekoch za \u00fa\u010delom z\u00edskania vedeck\u00fdch d\u00f4kazov o \u00fa\u010dinnosti a bezpe\u010dnosti lieku.<\/p>\n<p>Na tieto \u0161t\u00fadie sa samozrejme vz\u0165ahuj\u00fa pr\u00edsne predpisy, ktor\u00fdch cie\u013eom je zabezpe\u010di\u0165 prospech pacienta. Mnoho pacientov m\u00e1 mo\u017enos\u0165 z\u00fa\u010dastni\u0165 sa klinickej \u0161t\u00fadie, \u010di u\u017e na Slovensku, alebo v zahrani\u010d\u00ed. Cie\u013eom tohto \u010dl\u00e1nku je poda\u0165 im inform\u00e1cie ak\u00e9 mo\u017en\u00e9 v\u00fdhody a rizik\u00e1 plyn\u00fa z \u00fa\u010dasti na klinickej \u0161t\u00fadii, \u010do m\u00f4\u017eu v jej priebehu o\u010dak\u00e1va\u0165 a ak\u00fd m\u00e1 pre nich \u00fa\u010das\u0165 v\u00fdznam. Z\u00e1rove\u0148 \u010dl\u00e1nok opisuje ak\u00e9 je postavenie klinick\u00fdch \u0161t\u00fadii v procese v\u00fdvoja nov\u00e9ho lieku a umo\u017enuje t\u00fdm ka\u017ed\u00e9mu z\u00edska\u0165 lep\u0161\u00ed preh\u013ead o procese od n\u00e1jdenia nov\u00e9ho lie\u010diva po uvedenie na trh.<\/p>\n<h4><strong>Vymedzenie a v\u00fdznam klinick\u00e9ho sk\u00fa\u0161ania<\/strong><\/h4>\n<p><strong><\/strong>Klinickou \u0161t\u00fadiou sa rozumie klinick\u00e9 sk\u00fa\u0161anie lieku alebo zdravotn\u00edckej pom\u00f4cky. Na tieto \u0161t\u00fadie sa vz\u0165ahuje mno\u017estvo pr\u00e1vnych a technick\u00fdch predpisov, ktor\u00e9 maj\u00fa zaru\u010di\u0165 predov\u0161etk\u00fdm prvorados\u0165 prospechu pacienta a zabezpe\u010di\u0165 vedeck\u00fa hodnotu v\u00fdsledkov \u0161t\u00fadie. Cie\u013eom klinick\u00fdch \u0161t\u00fadii je z\u00edska\u0165 d\u00f4kaz o \u00fa\u010dinnosti a bezpe\u010dnosti sk\u00fa\u0161an\u00e9ho lie\u010diva, liek m\u00f4\u017ee by\u0165 uveden\u00fd na trh a\u017e po \u00faspe\u0161nej klinickej \u0161t\u00fadii. Klinick\u00e1 \u0161t\u00fadia m\u00f4\u017ee sk\u00fama\u0165 aj \u00fa\u010dinok lieku, ktor\u00fd u\u017e bol uveden\u00fd na trh ,v pr\u00edpade \u017ee sa sk\u00fama jeho \u00fa\u010dinok v novej indik\u00e1cii (na ochorenie na ktor\u00e9 sa predt\u00fdm nepou\u017e\u00edval). V\u0161eobecn\u00fdm princ\u00edpom teda je \u017ee ka\u017ed\u00e9 lie\u010divo (zdravotn\u00edcka pom\u00f4cka) mus\u00ed v ka\u017edej indik\u00e1cii v ktorej sa bude pou\u017e\u00edva\u0165 preuk\u00e1za\u0165 vedeck\u00fdmi met\u00f3dami vhodnos\u0165 pou\u017eitia \u2013 \u010do je princ\u00edp vych\u00e1dzaj\u00faci z konceptu Evidence Based Medicine (EBM, medic\u00edna zalo\u017een\u00e1 na d\u00f4kazoch). \u0160pecifick\u00fdm druhom \u0161t\u00fadie je bioekvivalen\u010dn\u00e1 \u0161t\u00fadia ktor\u00e1 neposudzuje nov\u00e9 lie\u010divo, ale jeho obmenu v inom lieku od in\u00e9ho v\u00fdrobcu \u2013 generick\u00fd liek. Tie\u017e pri niektor\u00fdch pr\u00edpravkoch, ktor\u00e9 s\u00fa registrovan\u00e9 ako lieky, nie s\u00fa klinick\u00e9 \u0161t\u00fadie po\u017eadovan\u00e9 \u2013 v pr\u00edpade homeopat\u00edk a niektor\u00fdch\u00a0 tradi\u010dn\u00fdch rastlinn\u00fdch pr\u00edpravkov. D\u00f4vodom v pr\u00edpade homeopat\u00edk je ich vedecky preuk\u00e1zan\u00e1 ne\u00fa\u010dinnos\u0165.<\/p>\n<div style=\"text-align: center;\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter\" style=\"border: 0px; margin-top: 20px; margin-bottom: 20px;\" title=\"201212062107_klinicka_studia1\" alt=\"201212062107_klinicka_studia1\" src=\"https:\/\/slanedeti.sk\/cms\/picture_migration\/201212062107_klinicka_studia1.jpg\" width=\"400\" height=\"258\" border=\"0\" \/><\/div>\n<p>Okrem tohto jednozna\u010dn\u00e9ho vymedzenia s\u00fa \u010fal\u0161ie pr\u00edpady, ke\u010f postup a cie\u013e m\u00f4\u017ee pripom\u00edna\u0165 klinick\u00fa \u0161t\u00fadiu ale nenap\u013e\u0148a ju tak ako je definovan\u00e1 vy\u0161\u0161ie. Je\u00a0 mno\u017estvo produktov ktor\u00e9 pripom\u00ednaj\u00fa lieky (v\u00fd\u017eivov\u00e9 doplnky, lie\u010debn\u00e1 kozmetika) ale nie s\u00fa nimi v zmysle platnej legislat\u00edvy. To znamen\u00e1 \u017ee v pr\u00edpade t\u00fdchto produktov nie je vedecky dokumentovan\u00e1 ich \u00fa\u010dinnos\u0165. Pr\u00e1ve v\u00fdrobcovia t\u00fdchto produktov sa \u010dasto sna\u017eia spotrebite\u013eov presved\u010di\u0165 \u017ee \u00fa\u010dinnos\u0165 ich produktu je preuk\u00e1zan\u00e1 klinickou \u0161t\u00fadiou. Je potrebn\u00e9 uvedomi\u0165 si \u017ee tieto \u0161t\u00fadie, aj ke\u010f m\u00f4\u017eu by\u0165 publikovan\u00e9 vo vedeck\u00fdch periodik\u00e1ch, nie s\u00fa spravidla uskuto\u010dnovan\u00e9 pod\u013ea \u0161tandardov pre klinick\u00e9 hodnotenie liekov a ich v\u00fdsledky m\u00f4\u017eu by\u0165 vzh\u013eadom na ich dizajn diskutabiln\u00e9.<\/p>\n<h4><strong>\u0160t\u00e1di\u00e1 klinick\u00e9ho sk\u00fa\u0161ania<\/strong><\/h4>\n<p><strong><\/strong>Klinick\u00e9 \u0161t\u00fadie predstavuj\u00fa pokro\u010dil\u00fa f\u00e1zu v\u00fdvoja nov\u00e9ho lie\u010diva. V\u00fdvoj sa spravidla za\u010d\u00edna v laborat\u00f3riu, nov\u0161ie pr\u00edstupy zah\u0155\u0148aj\u00fa aj po\u010d\u00edta\u010dov\u00e9 modelovanie. Laborat\u00f3rne (in vitro) \u0161t\u00fadiami sa preveruje ve\u013ek\u00e9 mno\u017estvo molek\u00fal no iba pri malom po\u010dte sa zistia vlastnoti, ktor\u00e9 m\u00f4\u017eu nazna\u010dova\u0165 terapeutick\u00fd \u00fa\u010dinok. Pri t\u00fdchto sa sleduje \u00fa\u010dinok na tkanivov\u00fdch kult\u00farach (in situ) a na zvierat\u00e1ch (in vivo). F\u00e1za ktor\u00e1 predch\u00e1dza klinick\u00e9mu sk\u00fa\u0161aniu sa ozna\u010duje predklinick\u00e9 sk\u00fa\u0161anie. Pri \u0148om sa na zvierat\u00e1ch stanovia \u00fadaje o ak\u00fatnej toxicite, mutagenite, karcinogenite, \u00fadaje o d\u00e1vkovan\u00ed, chovan\u00ed sa lie\u010diva v organizme a \u00fa\u010dinkoch. V pr\u00edpade, \u017ee v\u00fdsledky nazna\u010duj\u00fa \u017ee lie\u010divo je bezpe\u010dn\u00e9 zo z\u00edskan\u00fdch\u00a0\u00a0 \u00fadajov sa vytvor\u00ed model d\u00e1vkovania pre \u013eud\u00ed.<\/p>\n<p>Klinick\u00e9 hodnotenie sa \u0161tandardne rozde\u013euje do \u0161tyroch f\u00e1z (I \u2013 IV). Najnov\u0161ie boli publikovan\u00e9 predpisy tie\u017e pre f\u00e1zu 0.<\/p>\n<ul>\n<li><strong>0 f\u00e1za<\/strong> je podanie sk\u00fa\u0161an\u00e9ho lie\u010diva mal\u00e9mu po\u010dtu (10 \u2013 15) zdrav\u00fdch dobrovo\u013en\u00edkov v n\u00edzkych d\u00e1vkach, pri\u010dom sa sleduje osud lie\u010diva v organizme a \u00fa\u010dinky.<\/li>\n<li>V <strong>I. f\u00e1ze<\/strong> je lie\u010divo podan\u00e9 malej skupine (20 &#8211; 80) zdrav\u00fdch dobrovoln\u00edkov. Podan\u00e9 s\u00fa r\u00f4zne d\u00e1vky pre ur\u010denie optim\u00e1lneho d\u00e1vkovania. T\u00e1to f\u00e1za spravidla obsahuje viacero testov chovania sa lie\u010diva a \u00fa\u010dinku ako napr\u00edklad tolerabilita, ovlyvnenie absorbcie jedlom a \u010fal\u0161ie. Dobrovo\u013en\u00edci s\u00fa neust\u00e1le sledovan\u00fd v nemocnici (\u010dasto \u0161pecializovanej na klinick\u00e9 \u0161t\u00fadie) Lie\u010divo aby post\u00fapilo do \u010fal\u0161ej f\u00e1zy (pri ka\u017edej f\u00e1ze) sa mus\u00ed preuk\u00e1za\u0165 by\u0165 dostato\u010dne bezpe\u010dn\u00e9.<\/li>\n<li><strong>F\u00e1za II<\/strong>. je sk\u00f4r roz\u0161\u00edren\u00edm f\u00e1zy I. nako\u013eko zah\u0155\u0148a vy\u0161\u0161\u00ed po\u010det dobovo\u013en\u00edkov a prv\u00fd kr\u00e1t tie\u017e pacientov. Ve\u013ekos\u0165 skupiny je ale st\u00e1la dos\u0165 mal\u00e1 (20 \u2013 300). Niekedy s\u00fa f\u00e1zy I. a II. ch\u00e1pan\u00e9 ako jeden celok.<\/li>\n<li>A\u017e <strong>f\u00e1za III.<\/strong> je prv\u00fdm rozsiahlej\u0161\u00edm sk\u00fa\u0161an\u00edm lieku s \u00fa\u010das\u0165ou v\u00e4\u010d\u0161ej pacientskej popul\u00e1cie. Ve\u013ek\u00e1 v\u00e4\u010d\u0161ina pacientov \u010do sa z\u00fa\u010dastn\u00ed nejakej \u0161t\u00fadie je pr\u00e1ve v tejto f\u00e1ze. Konkr\u00e9tny po\u010det z\u00e1vis\u00ed od mnoh\u00fdch faktorov, ako roz\u0161\u00edrenosti ochorenia a odhadu ak\u00fd ve\u013ek\u00fd s\u00fabor je potrebn\u00fd na zaznamenanie ved\u013eaj\u0161\u00edch \u00fa\u010dinkov a terapeutickej variability. Jedn\u00e1 sa od desiatok po tis\u00edcky \u013eud\u00ed. Jedna \u0161t\u00fadia sa spravidla uskuto\u010d\u0148uje vo viacer\u00fdch krajin\u00e1ch \u010di kontinentoch a z\u00e1rove\u0148 v mnoh\u00fdch zdravotn\u00fdch zariadeniach v r\u00e1mci krajiny (\u0161t\u00fadie s\u00fa \u201cmulticentrick\u00e9\u201d ). D\u00f4vodom je jednak z\u00edska\u0165 dostato\u010dn\u00fd po\u010det pacientov a tie\u017e \u010do najv\u00e4\u010d\u0161iu variabilitu. V tejto f\u00e1ze sa sk\u00fa\u0161an\u00e9 lie\u010divo pod\u00e1va pacientom v predpokladan\u00fdch terapeutick\u00fdch d\u00e1vkach, pri\u010dom sa d\u00f4kladne vyhodnocuje zdravotn\u00fd stav a ne\u017eiad\u00face \u00fa\u010dinky. F\u00e1za III. je kritick\u00e1 pre rozhodnutie \u010di bude lie\u010divo uveden\u00e9 na trh. V pr\u00edpade \u017ee v\u00fdsledky s\u00fa uspokojiv\u00e9 \u00fadaje zo \u0161t\u00fadii s\u00fa spracovan\u00e9 do \u017eiadosti o registr\u00e1ciu lieku. Ve\u013ek\u00e1 v\u00e4\u010d\u0161ina \u0161t\u00fadii ktor\u00e9 prebiehaj\u00fa v strednej E\u00far\u00f3pe s\u00fa III. f\u00e1zy.<\/li>\n<li>Ako <strong>f\u00e1za<\/strong> <strong>IIIb<\/strong> sa niekedy ozna\u010duje pokra\u010dovanie \u0161t\u00fadie f\u00e1zy III, po tom \u010do u\u017e bola podan\u00e1 \u017eiados\u0165 o registr\u00e1ciu sk\u00fa\u0161an\u00e9ho lieku.<\/li>\n<li><strong>F\u00e1za IV<\/strong> prebieha a\u017e po uveden\u00ed lieku na trh a predstavuje dlhodob\u00e9 sledovanie jeho terapeutick\u00fdch a pr\u00edpadne \u010fal\u0161\u00edch ne\u017eiad\u00facich \u00fa\u010dinkov. Ved\u013eaj\u0161ie \u00fa\u010dinky a interakcie s in\u00fdmi liekmi s\u00fa najviac sledovan\u00e9 okolnosti po\u010das tejto f\u00e1zy. Na z\u00e1klade \u0161tatistick\u00e9ho spracovania \u00fadajov s\u00fa formulovan\u00e9 \u010fal\u0161ie predpoklady alebo z\u00e1very o terapeutickej hodnote lieku. Taktie\u017e kontroln\u00fd \u00farad, ktor\u00fd schvaluje uvedenie na trh m\u00f4\u017ee nariadi\u0165 dlhodob\u00e9 sledovanie ur\u010dit\u00fdch vlastnost\u00ed ako podmienku uvedenia na trh. V\u00fdsledkom sledovania vo f\u00e1ze IV teda m\u00f4\u017ee by\u0165 jednak \u017eiadne zmeny \u2013 ak neprinesie nov\u00e9 poznatky, \u0161peci\u00e1lne odpor\u00fa\u010dania oh\u013eadom u\u017e\u00edvania lieku, n\u00e1vrh roz\u0161\u00edrenia alebo z\u00fa\u017eenia pou\u017eitia, pr\u00edpadne aj stiahnutie lieku z trhu.<\/li>\n<\/ul>\n<h4><strong>Organiz\u00e1cia klinick\u00e9ho sk\u00fa\u0161ania<\/strong><\/h4>\n<p><strong><\/strong>Klinick\u00fa \u0161t\u00fadiu spravidla vykon\u00e1va farmaceutick\u00e1 firma, ktor\u00e1 vyvinula nov\u00e9 lie\u010divo. Ni\u010d ale neobmedzuje in\u00e9 organiz\u00e1cie (ktor\u00e9 sp\u013a\u0148aj\u00fa z\u00e1konn\u00e9 predpoklady) taktie\u017e organizova\u0165 klinick\u00e9 \u0161t\u00fadie \u010do sa vo vyspel\u00fdch krajin\u00e1ch aj deje. M\u00f4\u017eu to by\u0165 \u0161t\u00e1tne in\u0161tit\u00facie (ako National Institutes of Health), univerzitn\u00e9 v\u00fdskumn\u00e9 pracovisk\u00e1, v poslednej \u010dase s\u00fa v tomto smere akt\u00edvnej\u0161ie aj pacientske organiz\u00e1cie. V strednej Eur\u00f3pe ale jednozna\u010dne\u00a0 ako zad\u00e1vate\u013eia dominuj\u00fa medzin\u00e1rodn\u00e9 farmaceutick\u00e9 spolo\u010dnosti. Nie v\u017edy v\u0161ak firma ktor\u00e1 lie\u010divo vyvinula preber\u00e1 cel\u00fa organiz\u00e1ciu \u0161t\u00fadie. \u010casto si najme \u0161pecializovan\u00e9 servisn\u00e9 firmy \u2013 Contract Research Organization (CRO) ktor\u00e9 organiz\u00e1ciu preber\u00fa a n\u00e1sledne odovzdaj\u00fa zad\u00e1vate\u013eovi v\u00fdsledky \u0161t\u00fadie. To je pr\u00edpadom najm\u00e4 pre mal\u00e9 biotechnologick\u00e9 firmy, ktor\u00e9 ani nemaj\u00fa kapacitu vies\u0165 celosvetov\u00e9 \u0161t\u00fadie. Klinick\u00e9 sk\u00fa\u0161anie je finan\u010dne najn\u00e1ro\u010dnej\u0161ou f\u00e1zou v\u00fdvoja nov\u00e9ho lie\u010diva. Ak sa priemern\u00e9 n\u00e1klady na uvedenie nov\u00e9ho lie\u010diva na trh rovnaj\u00fa pribli\u017ene miliarde dol\u00e1rov, klinick\u00e9 \u0161t\u00fadie m\u00f4\u017eu zhltn\u00fa\u0165 80 %. Obdobie od za\u010diatku klinick\u00e9ho sk\u00fa\u0161ania po z\u00edskanie rozhodnutia o registr\u00e1cii lieku je zvy\u010dajne nieko\u013eko rokov.<\/p>\n<p>Z\u00e1kladn\u00fdmi dokumentmi ktor\u00e9 s\u00fa \u0161tandardizovan\u00e9 a vypracovan\u00e9 pre ka\u017ed\u00fa klinick\u00fa \u0161t\u00fadiu s\u00fa:<\/p>\n<ul>\n<li>\u017diados\u0165 o povolenie klinick\u00e9ho sk\u00fa\u0161ania (Clinical Trial Application) \u2013 predklad\u00e1 sa \u0161t\u00e1tnemu kontroln\u00e9mu \u00faradu spolu s ostatn\u00fdmi ni\u017e\u0161ie uveden\u00fdmi dokumentmi. Na jej z\u00e1klade \u00farad vyd\u00e1 rozhodnutie \u010di schvaluje za\u010datie \u0161t\u00fadie. Podobn\u00e1 \u017eiados\u0165 sa predklad\u00e1 na etick\u00e9 komisie.<\/li>\n<li>Protokol \u0161t\u00fadie (Study Protocol) \u2013 z\u00e1kladn\u00fd dokument ktor\u00fd podrobne opisuje ciele a princ\u00edpy sk\u00fa\u0161ania, \u010dasov\u00fd pl\u00e1n, dizajn \u0161t\u00fadie, met\u00f3dy spracovania v\u00fdsledkov a v\u0161etky relevantn\u00e9 inform\u00e1cie vz\u0165ahuj\u00face sa k \u0161t\u00fadii.<\/li>\n<li>Bro\u017e\u00fara pre sk\u00fa\u0161aj\u00faceho (Investigator Brochure) \u2013 je ur\u010den\u00e1 pre lek\u00e1ra (sk\u00fa\u0161aj\u00faceho), obsahuje s\u00fahrn v\u0161etk\u00fdch relevantn\u00fdch poznatkov o sk\u00fa\u0161anom lie\u010diva na z\u00e1klade doteraj\u0161ieho v\u00fdskumu.<\/li>\n<li>Informovan\u00fd s\u00fahlas (Informed Consent) \u2013 je ur\u010den\u00e1 pre \u00fa\u010dastn\u00edka \u0161t\u00fadie (pacienta), informuje ho o cie\u013eoch \u0161t\u00fadie, mo\u017enostiach lie\u010dby, pr\u00e1vach, v\u00fdhod\u00e1ch a rizik\u00e1ch \u00fa\u010dasti, pr\u00edpadne obsahuje \u010fal\u013eie relevantn\u00e9 inform\u00e1cie. \u00da\u010dastn\u00edk (alebo jeho pr\u00e1vny z\u00e1stupca) mus\u00ed podp\u00edsa\u0165 informovan\u00fd s\u00fahlas na to aby mohol by\u0165 zaraden\u00fd do \u0161t\u00fadie.<\/li>\n<li>Technick\u00e1 dokument\u00e1cia k lie\u010divu (Investigational Medicinal Product Dossier) \u2013 obsahuje v\u00fdsledky doteraj\u0161ieho (predklinick\u00e9ho) sk\u00fa\u0161ania, inform\u00e1cie o technol\u00f3gii v\u00fdroby sk\u00fa\u0161an\u00e9ho lieku a v\u00fdrobcovi.<\/li>\n<li>Z\u00e1znamov\u00e9 formul\u00e1re (Case Report Forms) \u2013 sl\u00fa\u017eia sk\u00fa\u0161aj\u00facemu na z\u00e1znam v\u00fdsledkov sk\u00fa\u0161ania, vyp\u013a\u0148aj\u00fa sa priebe\u017ene po\u010das \u0161t\u00fadie, na z\u00e1klade v\u00fdsledkov zisten\u00fdch pri n\u00e1v\u0161tev\u00e1ch pacienta. V s\u00fa\u010dastnosti maj\u00fa preva\u017ene iba elektronick\u00fa podobu.<\/li>\n<\/ul>\n<p>Aj vzh\u013eadom na regula\u010dn\u00e9 predpisy a \u0161tandardy farmaceutick\u00e9ho priemyslu \u0161t\u00fadie maj\u00fa pomerne ust\u00e1len\u00e9 postupy a z\u00e1sady ich projektov\u00e9ho mana\u017ementu zo strany zad\u00e1vate\u013ea. Jednotliv\u00e9 kroky by sa zjednodu\u0161ene dali op\u00edsa\u0165 nasledovne. Po tom \u010do sa pr\u00edjme rozhodnutie, \u017ee dan\u00e9 lie\u010divo sp\u013a\u0148a podmienky pre klinick\u00e9 sk\u00fa\u0161anie a m\u00e1 perspekt\u00edvu pre \u00faspech, na farmaceutickom trhu skupina expertov priprav\u00ed pl\u00e1n \u0161t\u00fadie a protokol. Nasleduje zis\u0165ovanie, ktor\u00ed lek\u00e1ri maj\u00fa podmienky a z\u00e1ujem na \u0161t\u00fadii pracova\u0165 (feasibility study). Toto zis\u0165ovanie sa \u0161tandartne uskuto\u010dn\u00ed rozoslan\u00edm dotazn\u00edkov lek\u00e1rom, ktor\u00ed lie\u010dia pacientov na ochorenie pre ktor\u00e9 je sk\u00fa\u0161an\u00e9 lie\u010divo ur\u010den\u00e9. Na z\u00e1klade v\u00fdsledkov tohto zis\u0165ovania sa pr\u00edjme pl\u00e1n, ktor\u00e9 krajiny a pribli\u017ene ktor\u00ed lek\u00e1ri bud\u00fa zahrnut\u00fd do \u0161t\u00fadie. Hne\u010f na to je mo\u017en\u00e9 za\u010da\u0165 pripravova\u0165 podania na regula\u010dn\u00e9 \u00farady vybran\u00fdch kraj\u00edn a etick\u00e9 komisie. Jedn\u00e1 sa o proces pri ktorom je potrebn\u00e9 skompilova\u0165 zna\u010dn\u00e9 mno\u017etvo dokument\u00e1cie. Z\u00e1rove\u0148 sa za\u010dne pr\u00e1ca na uzatv\u00e1ran\u00ed zml\u00fav so v\u0161etk\u00fdmi zainteresovan\u00fdmi stranami \u2013 lek\u00e1rmi (v r\u00e1mci klinick\u00fdch \u0161t\u00fadii sa tie\u017e ozna\u010duj\u00fa ako sk\u00fa\u0161aj\u00faci alebo investig\u00e1tori), diagnostick\u00fdmi pracoviskami, je potrebn\u00e9 zabezpe\u010di\u0165 distrib\u00faciu sk\u00fa\u0161an\u00e9ho lieku. Pod\u013ea potreby poskytn\u00fa\u0165 lek\u00e1rom a zdravotn\u00edckemu person\u00e1lu \u0161kolenie alebo tr\u00e9ning, podpori\u0165 n\u00e1bor pacientov (informa\u010dnou kampa\u0148ou). Osoba, ktor\u00e1 reprezentuje zad\u00e1vate\u013ea a komunikuje s lek\u00e1rom ako z\u00e1stupca farmaceutickej firmy, sa ozna\u010duje ako monitor \u0161t\u00fadie (alebo tie\u017e Clinical Research Associate, CRA). Je tie\u017e opr\u00e1vnen\u00e1 kontrolova\u0165 \u010di lek\u00e1r dodr\u017eiava technick\u00e9 a etick\u00e9 po\u017eiadavky na uskuto\u010d\u0148ovanie klinick\u00fdch \u0161t\u00fadii. V\u0161etky vz\u0165ahy medzi lek\u00e1rom a zad\u00e1vate\u013eom s\u00fa upraven\u00e9 v zmluve o klinickej \u0161t\u00fadii (Investigator Agreement). Lek\u00e1ri s\u00fa samozrejme za svoju pr\u00e1cu na \u0161t\u00fadi\u00e1ch honorovan\u00fd. V\u00fd\u0161ka odmeny je ve\u013emi r\u00f4zna, rozdiely s\u00fa aj pod\u013ea zamerania \u0161t\u00fadie \u2013 medzi najlukrat\u00edvnej\u0161ie patria najm\u00e4 onkologick\u00e9 \u0161t\u00fadie, ked\u017ee v tejto skupine je ve\u013ea sk\u00fa\u0161an\u00fdch liekov a najostrej\u0161ia konkurencia. Odmena je zvy\u010dajne fixn\u00fd poplatok za zahrnutie pacienta a n\u00e1sledne platby po\u010das \u0161t\u00fadie, ktor\u00e9 sa odv\u00edjaj\u00fa od po\u010dtu n\u00e1v\u0161tev pacienta a n\u00e1ro\u010dnosti vy\u0161etren\u00ed resp. dal\u0161\u00edch n\u00e1rokov v s\u00favislosti so \u0161t\u00fadiou. V niektor\u00fdch pr\u00edpadoch m\u00f4\u017ee zad\u00e1vate\u013e pom\u00f4c\u0165 lek\u00e1rovi aj zak\u00fapen\u00edm alebo zapo\u017ei\u010dan\u00edm technick\u00e9ho vybavenia, najm\u00e4 ak je potrebn\u00e9 k uskuto\u010dneniu \u0161t\u00fadie a lek\u00e1r n\u00edm nedisponuje. Pracovisko kde sa \u0161t\u00fadia vykon\u00e1va sa tie\u017e ozna\u010duje ako centrum.<\/p>\n<p>V optim\u00e1lnom pr\u00edpade s\u00fa v\u0161etky zmluvy a n\u00e1le\u017eitosti k spusteniu \u0161t\u00fadie pripraven\u00e9 do vydania rozhodnutia regula\u010dn\u00e9ho \u00faradu a etickej komisie. Regula\u010dn\u00e9 \u00farady pomerne \u010dasto po\u017eaduj\u00fa doplnenie dokument\u00e1cie, pr\u00edpadne nov\u00e9 predklinick\u00e9 testy, alebo aj zmeny v dizajne \u0161t\u00fadie. Pr\u00edpady \u00fapln\u00e9ho zamietnutia \u0161t\u00fadii s\u00fa menej \u010dast\u00e9. \u010cas spustenia \u0161t\u00fadie sa preto zvy\u010dajne predl\u017euje minim\u00e1lne na nieko\u013eko mesiacov. Pri za\u010dat\u00ed \u0161t\u00fadie zad\u00e1vate\u013e spravidla zorganizuje stretnutie v\u0161etk\u00fdch sk\u00fa\u0161aj\u00facich kde ich detailne informuje o priebehu a postupoch s priestorom pre diskusiu (investigator`s meeting). \u0160t\u00fadia n\u00e1sledne prebieha pod\u013ea toho ako je op\u00edsan\u00e1 v protokole. Ve\u013ek\u00fd d\u00f4raz sa kladie na hl\u00e1senie ne\u017eiad\u00facich \u00fa\u010dinkov, o ktor\u00fdch musia pod\u013ea stup\u0148a z\u00e1va\u017enosti by\u0165 informovan\u00e9 regula\u010dn\u00e9 \u00farady. Zad\u00e1vate\u013e tie\u017e raz ro\u010dne po\u010das trvania \u0161t\u00fadie regula\u010dn\u00e9mu \u00faradu pod\u00e1va spr\u00e1vu o jej priebehu. Pri ukon\u010den\u00ed \u0161t\u00fadie musia by\u0165 v\u0161etky pracovisk\u00e1 ofici\u00e1lne ukon\u010di\u0165 pr\u00e1cu na v\u00fdskumnom projekte a zad\u00e1vate\u013e tie\u017e vypracuje spr\u00e1vu o \u0161t\u00fadii, ktor\u00fa odovzd\u00e1 regula\u010dn\u00e9mu \u00faradu. V\u0161etky balenia sk\u00fa\u0161an\u00fdch liekov musia by\u0165 odovzdan\u00e9 nasp\u00e4\u0165 zad\u00e1vate\u013eovi.<\/p>\n<p>V nasleduj\u00facej \u010dasti:<\/p>\n<ul>\n<li>Trendy vo v\u00fdvoji lie\u010div<\/li>\n<li>Ak\u00e9 s\u00fa pr\u00e1va pacienta v klinickej \u0161t\u00fadii?<\/li>\n<li>Ak\u00fd prospech m\u00f4\u017ee pacient z\u00edska\u0165 \u00fa\u010das\u0165ou na klinickej \u0161t\u00fadii?<\/li>\n<li>Ak\u00e9 s\u00fa nev\u00fdhody a rizik\u00e1 \u00fa\u010dasti na klinickej \u0161t\u00fadii?<\/li>\n<li>Ak\u00fd je pre pacienta typick\u00fd priebeh klinickej \u0161t\u00fadie?<\/li>\n<li>Ako sa pacient mo\u017ee prihl\u00e1si\u0165 do klinickej \u0161t\u00fadie?<\/li>\n<li>Ako s\u00fa klinick\u00e9 \u0161t\u00fadie regulovan\u00e9?<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Klinick&aacute; &scaron;t&uacute;dia je pokro&#269;ilou f&aacute;zou v&yacute;voja nov&eacute;ho lieku, ke&#271; sa sk&uacute;&scaron;obne pod&aacute;va &#318;udom. Klinick&uacute; &scaron;t&uacute;diu je nevyhnutn&eacute; vykona&#357; takmer pri v&scaron;etk&yacute;ch nov&yacute;ch liekoch za &uacute;&#269;elom z&iacute;skania vedeck&yacute;ch d&ocirc;kazov o &uacute;&#269;innosti a bezpe&#269;nosti lieku. Na tieto &scaron;t&uacute;die sa samozrejme vz&#357;ahuj&uacute; pr&iacute;sne &hellip; <a href=\"https:\/\/slanedeti.sk\/cms\/klinicke-studie-co-by-mal-pacient-vediet-i-cast-2\/917\">Continued<\/a><\/p>\n","protected":false},"author":7,"featured_media":1110,"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-917","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 v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Klinick\u00e9 \u0161t\u00fadie: \u010co by mal pacient vedie\u0165 - I. \u010das\u0165 - Slan\u00e9 deti<\/title>\n<meta name=\"description\" content=\"Cie\u013eom tohto \u010dl\u00e1nku je poda\u0165 inform\u00e1cie o mo\u017en\u00fdch v\u00fdhod\u00e1ch a rizik\u00e1ch plyn\u00facich z \u00fa\u010dasti na klinickej \u0161t\u00fadii.\" \/>\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-i-cast-2\/917\" \/>\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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