T\u00fcrkiye Sa\u011fl\u0131k Enstit\u00fcleri Ba\u015fkanl\u0131\u011f\u0131 (T\u00dcSEB) \u00fclkemiz i\u00e7in bir ilki daha ger\u00e7ekle\u015ftirerek T\u00dcSEB Klinik Ara\u015ft\u0131rmalar Merkezi\u2019ni kurdu.<\/p>\n
Ba\u015fkanl\u0131\u011f\u0131n\u0131 Prof. Dr. Adil Mardino\u011flu ve Genel Sekreterli\u011fini Prof. Dr. Hasan T\u00fcrkez\u2019in yapt\u0131\u011f\u0131 T\u00dcSEB yeni y\u00f6netim d\u00f6neminde k\u0131sa s\u00fcre i\u00e7erisinde \u00fclkemiz sa\u011fl\u0131k Ar-Ge ekosistemini geli\u015ftirmeye y\u00f6nelik yenilik\u00e7i yakla\u015f\u0131mlar arac\u0131l\u0131\u011f\u0131 ile \u00f6nemli geli\u015fmelere imza atmaya ba\u015flad\u0131. T\u00dcSEB taraf\u0131ndan yap\u0131lan yaz\u0131l\u0131 a\u00e7\u0131klamada, \u201cKlinik ara\u015ft\u0131rmalar, hastal\u0131klara kar\u015f\u0131 yeni tedavi y\u00f6ntemlerinin geli\u015ftirilmesini ve ila\u00e7 aday\u0131 olacak molek\u00fcllerin belirli a\u015famalardan ge\u00e7erek piyasaya \u00e7\u0131kmas\u0131n\u0131 sa\u011flayan, g\u00f6n\u00fcll\u00fc kat\u0131l\u0131mc\u0131larla ger\u00e7ekle\u015ftirilen ara\u015ft\u0131rmalar b\u00fct\u00fcn\u00fc olarak tan\u0131mlanabilir. Yap\u0131lan bu ara\u015ft\u0131rmalar\u0131n amac\u0131 insanlar\u0131n kullan\u0131m\u0131na sunulacak olan yeni ila\u00e7 veya t\u0131bbi cihaz\u0131n etkin ve g\u00fcvenilir oldu\u011funu kan\u0131tlamakt\u0131r. \u00dclkemizde yap\u0131lan klinik ara\u015ft\u0131rmalar\u0131n uluslararas\u0131 standartlara uygunlu\u011fu Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 taraf\u0131ndan takip edilmektedir. Klinik ara\u015ft\u0131rmalar, T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu taraf\u0131ndan onay verilen Etik Kurullar\u0131n onay\u0131 ve Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131n\u0131n izni ile ger\u00e7ekle\u015ftirilmektedir. Klinik ara\u015ft\u0131rmalar yeni ila\u00e7, t\u0131bbi cihaz ve geli\u015ftirilen tedavi y\u00f6ntemlerini hastalar\u0131n hizmetine sunmak a\u00e7\u0131s\u0131ndan \u00f6nem ta\u015f\u0131maktad\u0131r. Klinik ara\u015ft\u0131rmalar hastalara daha iyi tedavi imk\u00e2nlar\u0131 sa\u011flaman\u0131n yan\u0131 s\u0131ra g\u00fcncel teknolojilerden faydalanarak geli\u015ftirilen ila\u00e7 veya tedavi y\u00f6ntemlerinin hastalara zaman\u0131nda ula\u015ft\u0131r\u0131lmas\u0131n\u0131 ama\u00e7lamaktad\u0131r. Bu do\u011frultuda T\u00dcSEB, hastalar\u0131 yenilik\u00e7i tedavilerle bulu\u015fturmak amac\u0131yla, klinik ara\u015ft\u0131rmalara ve bu \u00e7al\u0131\u015fmalar\u0131n par\u00e7as\u0131 olan unsurlara destek verecektir” ifadesine yer verildi.<\/p>\n
A\u00e7\u0131klamada, “11. Kalk\u0131nma Plan\u0131 \u00e7er\u00e7evesinde klinik ara\u015ft\u0131rmalarda T\u00fcrkiye\u2019nin b\u00f6lgede lider \u00fclke konumuna gelmesinin sa\u011flanmas\u0131, klinik ara\u015ft\u0131rmalar\u0131n Ar-Ge faaliyeti kapsam\u0131na al\u0131nmas\u0131, klinik ara\u015ft\u0131rma konusunda fark\u0131ndal\u0131\u011f\u0131n artt\u0131r\u0131lmas\u0131 gibi konular \u00f6ng\u00f6r\u00fclmektedir. T\u00dcSEB\u2019e verilen yetkilerle T\u00fcrkiye\u2019deki klinik ara\u015ft\u0131rmalar\u0131n say\u0131s\u0131n\u0131n ve kalitesinin 11. Kalk\u0131nma Plan\u0131\u2019nda belirtilen hedefler do\u011frultusunda artt\u0131r\u0131lmas\u0131 planlanmaktad\u0131r. Bu kapsamda T\u00dcSEB b\u00fcnyesinde kurulmu\u015f olan Klinik Ara\u015ft\u0131rmalar Merkezi \u00fclkemizdeki klinik ara\u015ft\u0131rma pazar pay\u0131n\u0131 artt\u0131rmay\u0131 ama\u00e7lamaktad\u0131r. Klinik ara\u015ft\u0131rma yapmak isteyen ara\u015ft\u0131rmac\u0131lar\u0131n \u00e7al\u0131\u015fmalar\u0131 ger\u00e7ekle\u015ftirecekleri kurumlara y\u00f6nlendirilmesi, \u00e7al\u0131\u015fmalar\u0131n bir kamu kurulu\u015fu olan T\u00dcSEB \u00e7at\u0131s\u0131 alt\u0131nda takip edilmesi ve desteklenmesi sa\u011flanacakt\u0131r. Bu kapsamda T\u00dcSEB ihtiya\u00e7 halinde klinik ara\u015ft\u0131rma alan\u0131nda b\u00fct\u00e7e ve merkez izni s\u00fcre\u00e7lerinin y\u00f6netilmesi, protokol yaz\u0131m\u0131, etik kurul s\u00fcre\u00e7leri, mevzuat\/onay\/izin s\u00fcre\u00e7leri gibi konularda destek sunacakt\u0131r. Bu s\u00fcre\u00e7lere ek olarak, kurulan bu merkez klinik ara\u015ft\u0131rma payda\u015flar\u0131n\u0131 bilgilendirecek ve y\u00f6nlendirecek hasta veri k\u00fcmeleri sa\u011flamay\u0131 ama\u00e7lamaktad\u0131r. Klinik Ara\u015ft\u0131rmalar Merkezi\u2019nin temel ama\u00e7lar\u0131ndan bir di\u011feri ise klinik ara\u015ft\u0131rmalar konusundaki fark\u0131ndal\u0131\u011f\u0131 artt\u0131rmak ve \u00fclkemizde var olan klinik ara\u015ft\u0131rma potansiyelinin ulusal ve uluslararas\u0131 platformlarda tan\u0131n\u0131r olmas\u0131n\u0131 sa\u011flayacak \u00e7al\u0131\u015fmalar ger\u00e7ekle\u015ftirmektir. Bu kapsamda hem halk\u0131n hem de klinik ara\u015ft\u0131rmalar\u0131n yap\u0131laca\u011f\u0131 merkezlerde g\u00f6rev alan sa\u011fl\u0131k personelinin fark\u0131ndal\u0131\u011f\u0131n\u0131n artt\u0131r\u0131lmas\u0131 i\u00e7in \u00e7al\u0131\u015fmalar ger\u00e7ekle\u015ftirilecektir. \u015eehir hastanelerinde, \u00f6zel hastanelerde, \u00fcniversite hastanelerinde ve e\u011fitim ve ara\u015ft\u0131rma hastanelerinde geli\u015ftirilen altyap\u0131n\u0131n ara\u015ft\u0131rmac\u0131lar taraf\u0131ndan kullan\u0131lmas\u0131 te\u015fvik edilerek \u00fclkenin farkl\u0131 \u015fehirlerinde de klinik ara\u015ft\u0131rma yap\u0131lmas\u0131 sa\u011flanacakt\u0131r. T\u00dcSEB Klinik Ara\u015ft\u0131rmalar Merkezi maddi \u00e7\u0131kar g\u00f6zetmeksizin kamu b\u00fcnyesinde bir \u00e7at\u0131 kurum g\u00f6revi \u00fcstlenecektir.” denildi.<\/p>\n
Merkez b\u00fcnyesinde yap\u0131lmas\u0131 planlanan faaliyetler hakk\u0131nda \u015funlar kaydedildi:<\/p>\n
“Klinik ara\u015ft\u0131rma s\u00fcre\u00e7lerinde rol\u00fc olan; sponsor (\u00e7al\u0131\u015fmay\u0131 yapt\u0131ran kurum, kurulu\u015f), merkez (klinik ara\u015ft\u0131rman\u0131n yap\u0131laca\u011f\u0131 merkez), ara\u015ft\u0131rmac\u0131lar, CRO (S\u00f6zle\u015fmeli Ara\u015ft\u0131rma Kurulu\u015flar\u0131) ve SMO\u2018lar\u0131n (Merkez Y\u00f6netimi Organizasyonu) T\u00dcSEB Klinik Ara\u015ft\u0131rma Merkezi\u2019ne entegrasyonu sa\u011flanacakt\u0131r.<\/p>\n
Yap\u0131lan \u00e7al\u0131\u015fmalar ve \u00e7al\u0131\u015fma raporlar\u0131 ile \u00e7al\u0131\u015fmada g\u00f6rev alan ara\u015ft\u0131rmac\u0131lar koordine ve takip edilecektir.<\/p>\n
T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu\u2019na yap\u0131lan ba\u015fvurular ve etik kurul faaliyetleri koordine ve takip edilecektir.<\/p>\n
Etik kurul ba\u015fvuru, takip ve koordinasyon faaliyetleri s\u00fcrecinde elektronik sistem kullan\u0131lmas\u0131 amac\u0131yla \u00e7al\u0131\u015fmalar ger\u00e7ekle\u015ftirilecektir.<\/p>\n
Klinik ara\u015ft\u0131rma yapan b\u00fcy\u00fck \u00f6l\u00e7ekli firmalar\u0131n sorunlar\u0131na \u00e7\u00f6z\u00fcm getirmeye \u00e7al\u0131\u015f\u0131l\u0131rken, k\u00fc\u00e7\u00fck firmalar\u0131n geli\u015fmesi i\u00e7in olanaklar sa\u011flanacakt\u0131r.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"
BA\u015eKANLI\u011eINI PROF. DR. AD\u0130L MARD\u0130NO\u011eLU VE GENEL SEKRETERL\u0130\u011e\u0130N\u0130 PROF. DR. HASAN T\u00dcRKEZ\u2019\u0130N YAPTI\u011eI T\u00dcSEB YEN\u0130 Y\u00d6NET\u0130M D\u00d6NEM\u0130NDE KISA S\u00dcRE \u0130\u00c7ER\u0130S\u0130NDE \u00dcLKEM\u0130Z SA\u011eLIK AR-GE EKOS\u0130STEM\u0130N\u0130 GEL\u0130\u015eT\u0130RMEYE Y\u00d6NEL\u0130K YEN\u0130L\u0130K\u00c7\u0130 YAKLA\u015eIMLAR ARACILI\u011eI \u0130LE \u00d6NEML\u0130 GEL\u0130\u015eMELERE \u0130MZA ATMAYA BA\u015eLADI.<\/p>\n","protected":false},"author":1,"featured_media":194827,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[1],"tags":[22852,9487,415,295,38428],"class_list":["post-194826","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-genel","tag-arastirmalar","tag-klinik","tag-kuruldu","tag-merkezi","tag-tuseb"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/www.tvturk.com\/wp-content\/uploads\/2019\/08\/tuseb-klinik-arastirmalar-merkezi-kuruldu_d83ec06.jpg?fit=615%2C345","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/paKIfm-OGm","_links":{"self":[{"href":"http:\/\/www.tvturk.com\/index.php\/wp-json\/wp\/v2\/posts\/194826","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.tvturk.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.tvturk.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.tvturk.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.tvturk.com\/index.php\/wp-json\/wp\/v2\/comments?post=194826"}],"version-history":[{"count":0,"href":"http:\/\/www.tvturk.com\/index.php\/wp-json\/wp\/v2\/posts\/194826\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/www.tvturk.com\/index.php\/wp-json\/wp\/v2\/media\/194827"}],"wp:attachment":[{"href":"http:\/\/www.tvturk.com\/index.php\/wp-json\/wp\/v2\/media?parent=194826"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.tvturk.com\/index.php\/wp-json\/wp\/v2\/categories?post=194826"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.tvturk.com\/index.php\/wp-json\/wp\/v2\/tags?post=194826"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}