{"id":928,"date":"2013-07-16T20:40:24","date_gmt":"2013-07-16T18:40:24","guid":{"rendered":"http:\/\/slanedeti.sk\/cms\/otvoreny-pristup-k-udajom-klinickych-studii-2\/201307"},"modified":"2013-12-31T17:35:45","modified_gmt":"2013-12-31T16:35:45","slug":"otvoreny-pristup-k-udajom-klinickych-studii-2","status":"publish","type":"post","link":"https:\/\/slanedeti.sk\/cms\/otvoreny-pristup-k-udajom-klinickych-studii-2\/928","title":{"rendered":"Otvoren\u00fd pr\u00edstup k \u00fadajom klinick\u00fdch \u0161t\u00fadii"},"content":{"rendered":"<p>European Medicines Agency (EMA) sa sna\u017e\u00ed presadi\u0165 zmeny, ktor\u00e9 maj\u00fa vies\u0165 k v\u00e4\u010d\u0161ej transparentnosti a doh\u013eadu odbornej verejnosti nad vedeck\u00fdmi \u00fadajmi, z\u00edskan\u00fdmi farmaceutick\u00fdmi spolo\u010dnos\u0165ami po\u010das klinick\u00fdch \u0161t\u00fadii.<\/p>\n<p>Ak chce farmaceutick\u00e1 firma uvies\u0165 na trh nov\u00fd liek, mus\u00ed ho podrobi\u0165 viacer\u00fdm f\u00e1zam klinick\u00e9ho sk\u00fa\u0161ania (bli\u017e\u0161ie inform\u00e1cie o klinick\u00fdch \u0161t\u00fadi\u00e1ch v \u010dl\u00e1nku <a href=\"http:\/\/www.slanedeti.sk\/view.php?cisloclanku=2012120001\">Klinick\u00e9 \u0161t\u00fadie: \u010do by mal pacient vedie\u0165<\/a>). V\u00fdsledky t\u00fdchto \u0161t\u00fadii s\u00fa potom predlo\u017een\u00e9 ako podklad pre registr\u00e1ciu \u2013 schv\u00e1lenie uvedenia lieku na trh. Tieto v\u00fdsledky boli doteraz pova\u017eovan\u00e9 za komer\u010dne citliv\u00e9 inform\u00e1cie. Be\u017ene neboli \u00faradom predlo\u017een\u00e9 \u00fapln\u00e9 v\u00fdsledky \u0161t\u00fadii. Anal\u00fdza t\u00fdchto \u00fadajov tret\u00edmi stranami (najm\u00e4 na farmaceutickom priemysle nez\u00e1visl\u00fdmi farmakol\u00f3gmi) bola ve\u013emi problematick\u00e1 \u2013 \u010dasto z\u00e1visl\u00e1 od ochoty farmaceutick\u00fdch firiem tieto \u00fadaje poskytn\u00fa\u0165, pri\u010dom tak\u00e1 ochota zd\u00e1 sa bola sk\u00f4r v\u00fdnimkou ako pravidlom. Tie\u017e, aj ke\u010f boli \u00fadaje hodnoten\u00e9 expertmi na \u00faradoch zodpovedn\u00fdch za doh\u013ead nad liekmi, jednalo sa o ve\u013emi obmedzen\u00fd po\u010det os\u00f4b, ktor\u00e9 mohli vyjadri\u0165 vedeck\u00e9 stanovisko. Navy\u0161e je vhodn\u00e9 spomen\u00fa\u0165, \u017ee v pr\u00edpade niektor\u00fdch liekov sa vynorili aj \u010fal\u0161ie s\u00favisiace podozrenia \u2013 ako napr\u00edklad prisp\u00f4sobovanie dizajnu protokolov \u0161t\u00fadie pod\u013ea ich \u017eelan\u00fdch v\u00fdsledkov, alebo syst\u00e9m publikovania v odborn\u00fdch medic\u00ednskych \u010dasopisoch, ktor\u00fd v mnohom u\u013eah\u010duje farmaceutick\u00fdm spolo\u010dnostiam prezentova\u0165 inform\u00e1cie s marketingov\u00fdm v\u00fdznamom ako \u010disto odborn\u00e9. Tento stav sa stal ter\u010dom kritiky, dobre op\u00edsanej napr\u00edklad vo vplyvnom \u010dl\u00e1nku \u201c<a href=\"http:\/\/blogs.plos.org\/speakingofmedicine\/2012\/12\/07\/now-is-the-time-for-transparency-and-access-to-clinical-trial-data\/\">\u010cas na tranparentnos\u0165 a pr\u00edstup k \u00fadajom klinick\u00fdch \u0161t\u00fadii je teraz<\/a>\u201c Dr. Carla Henegena z University of Oxford.<\/p>\n<p>&nbsp;<\/p>\n<div style=\"text-align: center;\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter\" style=\"border: 0px; margin-top: 20px; margin-bottom: 20px;\" title=\"graf\" alt=\"graf\" src=\"https:\/\/slanedeti.sk\/cms\/picture_migration\/graf.png\" width=\"300\" height=\"225\" border=\"0\" \/><\/div>\n<p>&nbsp;<\/p>\n<p>Prelomov\u00fdm v tejto oblasti bol <a href=\"http:\/\/www.plosmedicine.org\/article\/info:doi\/10.1371\/journal.pmed.1001202\">\u010dl\u00e1nok<\/a> pod veden\u00edm Dr. Hans-Georg Eichlera z European Medicines Agency v ktorom sa vyjadril, \u017ee cie\u013eom EMA je spr\u00edstupni\u0165 \u00fadaje z klinick\u00fdch \u0161t\u00fadii a definoval ciele, ktor\u00e9 by sa t\u00fdm mali dosiahnu\u0165, ako aj obmedzenia ktor\u00e9 m\u00e1 EMA ma\u0165 na zreteli. Hlavn\u00fdm d\u00f4vodom pre spr\u00edstupnenie je mo\u017enos\u0165 na z\u00e1klade \u010fal\u0161ej anal\u00fdzy z\u00edska\u0165 nov\u00e9 vedeck\u00e9 poznatky, vy\u0161\u0161ia transparentnos\u0165 a naplnenie z\u00e1v\u00e4zku vo\u010di pacientom, ktor\u00fdch motiv\u00e1cia v \u00fa\u010dasti na klinick\u00fdch \u0161t\u00fadi\u00e1ch je prispie\u0165 k pokroku medic\u00ednskej vedy (\u010do nie je celkom naplnen\u00e9, ak s\u00fa \u00fadaje pova\u017eovan\u00e9 za komer\u010dn\u00e9 a dostupn\u00e9 iba vedcom pracuj\u00facim pre dan\u00fa farmaceutick\u00fa firmu). Ako obmedzenia\/rizik\u00e1 definoval ochranu osobn\u00fdch \u00fadajov, mo\u017enos\u0165, \u017ee \u00fadaje bud\u00fa spracovan\u00e9 nespr\u00e1vnymi metodol\u00f3giami, alebo \u00fa\u010delovo interpretovan\u00e9.<\/p>\n<p>Na t\u00e9mu spr\u00edstupnenia \u00fadajov klinick\u00fdch \u0161t\u00fadii sa na p\u00f4de European Medicines Agency\u00a0 22.novembra 2012 konal workshop, kde boli pozvan\u00ed z\u00e1stupcovia vedeckej komunity, farmaceutick\u00e9ho priemyslu, pacientskych organiz\u00e1cii a boli diskutovan\u00e9 podrobnosti a technick\u00e9 ot\u00e1zky s\u00favisiace so zverejnen\u00edm t\u00fdchto \u00fadajov. Ako \u00favodom uviedol Guido Rasi, v\u00fdkonn\u00fd riadite\u013e EMA, \u201cZ\u00e1v\u00e4zkom European Medicines Agency je proakt\u00edvne publikovanie \u00fadajov klinick\u00fdch \u0161t\u00fadii pre v\u0161etky lieky, ktor\u00e9 s\u00fa uveden\u00e9 na trh. Nie sme tu preto, aby sme rozhodovali o tom, \u010di spr\u00edstupni\u0165 \u00fadaje, ale ako\u201c. Cel\u00fd z\u00e1znam workshopu je zverejnen\u00fd na <a href=\"http:\/\/youtu.be\/upinaTryTho\">EMA youtube kan\u00e1li<\/a>\u00a0(anglicky, 2 hod.)<\/p>\n<p>Na z\u00e1klade tejto diskusie pripavila EMA <a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Other\/2013\/06\/WC500144730.pdf\">n\u00e1rvh politiky publik\u00e1cie a pr\u00edstupu k \u00fadajom klinick\u00fdch \u0161t\u00fadii<\/a>, ktor\u00fd 26. j\u00fana zverejnila <a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2013\/06\/news_detail_001825.jsp&amp;mid=WC0b01ac058004d5c1\">na svojej str\u00e1nke<\/a>, pri\u010dom vyzvala na jeho verejn\u00e9 pripomienkovanie. Pripomienky by mali by\u0165 zaslan\u00e9 do 30. septembra 2013.<\/p>\n<p>Hlavn\u00e9 body n\u00e1vrhu s\u00fa:<\/p>\n<ul>\n<li>Spr\u00edstupnenie \u00fadajov je na z\u00e1klade opodstatnen\u00fdch po\u017eiadaviek z\u00fa\u010dasnen\u00fdch str\u00e1n (najm\u00e4 vedeckej obce a z\u00e1stupcov pacientov), je to krok k v\u00e4\u010d\u0161ej transparentnosti, cesta k vy\u0161\u0161\u00edm \u0161tandardom v klinickom hodnoten\u00ed liekov, potenci\u00e1lny n\u00e1stroj pre z\u00edskavanie nov\u00fdch vedeck\u00fdch poznatkov.<\/li>\n<li>EMA bude obzvl\u00e1\u0161\u0165 dba\u0165 na ochranu osobn\u00fdch \u00fadajov pacientov, aj nad r\u00e1mec Eur\u00f3pskej legislat\u00edvy, so zrete\u013eom na v\u00fdvoj nov\u00fdch IT technol\u00f3gii v oblasti data miningu a n\u00e1strojov datab\u00e1z, ktor\u00e9 by teoreticky mohli deanonymizova\u0165 \u010das\u0165 \u00fadajov, v rozpore so z\u00e1rukami a \u0161tandardmi Eur\u00f3pskej liekovej legislat\u00edvy v oblasti ochrany osobn\u00fdch \u00fadajov pacientov.<\/li>\n<li>Po schv\u00e1len\u00ed uvedenia lieku na trh nebude EMA pova\u017eova\u0165 \u00fadaje klinick\u00fdch \u0161t\u00fadii predlo\u017een\u00e9 v jeho \u017eiadosti o registr\u00e1ciu za komer\u010dne d\u00f4vern\u00e9 inform\u00e1cie, ke\u010f\u017ee zaistenie verejn\u00e9ho zdravia pova\u017euje za d\u00f4le\u017eitej\u0161ie.<\/li>\n<li>EMA vyz\u00fdva v\u0161etk\u00fdch \u010do sa bud\u00fa podie\u013ea\u0165 na sekund\u00e1rnej anal\u00fdze \u00fadajov aby sa prid\u0155\u017eali uzn\u00e1van\u00fdch vedeck\u00fdch \u0161tandardov, ale samotn\u00e1 agent\u00fara nem\u00f4\u017ee nies\u0165 zodpovednos\u0165, ak sa vyskytn\u00fa pr\u00edpady, \u017ee \u00fadaje bud\u00fa tret\u00edmi stranami nespr\u00e1vne spracovan\u00e9 alebo nespr\u00e1vne interpretovan\u00e9.<\/li>\n<li>Spr\u00edstupnenie \u00fadajov sa t\u00fdka liekov, ktor\u00e9 bud\u00fa schv\u00e1len\u00e9 po tom ako t\u00e1to politika vst\u00fapi do platnosti (1. janu\u00e1ra 2014). Vz\u0165ahuje sa k liekom schv\u00e1len\u00fdm centralizovanou proced\u00farou.<\/li>\n<li>S\u00fabory bud\u00fa bu\u010f vo form\u00e1te portable document format (pdf) a m\u00e1 v nich by\u0165 umo\u017enen\u00e9 vyh\u013ead\u00e1vanie, alebo vo form\u00e1te, v ktorom boli prim\u00e1rne spracovan\u00e9, resp. v s\u00falade s po\u017eiadavkami CDISC (Clinical Data Interchange Standards Consortium).<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>European Medicines Agency (EMA) sa sna&#382;&iacute; presadi&#357; zmeny, ktor&eacute; maj&uacute; vies&#357; k v&auml;&#269;&scaron;ej transparentnosti a doh&#318;adu odbornej verejnosti nad vedeck&yacute;mi &uacute;dajmi, z&iacute;skan&yacute;mi farmaceutick&yacute;mi spolo&#269;nos&#357;ami po&#269;as klinick&yacute;ch &scaron;t&uacute;dii. Ak chce farmaceutick&aacute; firma uvies&#357; na trh nov&yacute; liek, mus&iacute; ho podrobi&#357; viacer&yacute;m &hellip; <a href=\"https:\/\/slanedeti.sk\/cms\/otvoreny-pristup-k-udajom-klinickych-studii-2\/928\">Continued<\/a><\/p>\n","protected":false},"author":7,"featured_media":1038,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"kt_blocks_editor_width":"","footnotes":""},"categories":[2],"tags":[],"class_list":["post-928","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-informacie"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Otvoren\u00fd pr\u00edstup k \u00fadajom klinick\u00fdch \u0161t\u00fadii - Slan\u00e9 deti<\/title>\n<meta name=\"description\" content=\"EMA sa sna\u017e\u00ed presadi\u0165 zmeny ved\u00face k v\u00e4\u010d\u0161ej transparentnosti a doh\u013eadu odbornej verejnosti nad \u00fadajmi z\u00edskan\u00fdmi po\u010das klinick\u00fdch \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\/otvoreny-pristup-k-udajom-klinickych-studii-2\/928\" \/>\n<meta property=\"og:locale\" content=\"sk_SK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Otvoren\u00fd pr\u00edstup k \u00fadajom klinick\u00fdch \u0161t\u00fadii - 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