{"id":3470,"date":"2022-10-19T19:55:48","date_gmt":"2022-10-19T19:55:48","guid":{"rendered":"https:\/\/clinicaltrials.allmedia.rs\/?page_id=3470"},"modified":"2023-06-25T15:04:51","modified_gmt":"2023-06-25T15:04:51","slug":"about-us","status":"publish","type":"page","link":"https:\/\/clinicaltrials.rs\/sr\/about-us\/","title":{"rendered":"O klini\u010dkim ispitivanjima"},"content":{"rendered":"
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O klini\u010dkim ispitivanjima<\/h3>\r\n\t\t\t\t

Svaki lek koji je danas dostupan nastao je zahvaljuju\u0107i klini\u010dkim ispitivanjima i pacijentima koji su bili voljni da\nu\u010destvuju u studijama.<\/em><\/p>\t\t\t<\/div>\r\n\t\t\t

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\u0160ta su klini\u010dke studije?<\/h3>\r\n\t\t\t\t

Klini\u010dke studije podrazumevaju ispitivanja koja se sprovode na ljudskoj populaciji da bi se ispitala ili potvrdila\nbezbednost i efikasnost ispitivanog medicinskog sredstva ili leka. Da bi novi, bezbedniji i efikasniji lekovi bili dostupni\npacijentima, potrebno je da pro\u0111u kroz kompleksan, vi\u0161egodi\u0161nji istra\u017eiva\u010dki proces.<\/p>

\u010citav proces po\u010dinje u laboratoriji, tkz. In-vitro ispitivanjima supstance koja je kandidat za novi lek. Ukoliko su rezultati\nobe\u0107avaju\u0107i, slede kompleksna ispitivanja na eksperimentalnim \u017eivotinjama, kako bi se prou\u010dili efekti leka u \u017eivom\norganizmu. Nakon ekstenzivnog prikupljanja i analize podataka iz ove faze, ukoliko su ispunjeni svi uslovi za dobijanje\nodobrenja od regulatornih tela, slede klini\u010dka ispitivanja, gde se lek testira u humanoj populaciji. To omogu\u0107ava\nprocenu bezbednosti i efikasnosti novog leka, a tako\u0111e omogu\u0107ava lekaru da pacijentu pru\u017ei novu opciju le\u010denja\nodre\u0111enog oboljenja.<\/p>

Samo 1 od 10 ispitivanih lekova uspe\u0161no prolazi klini\u010dka ispitivanja i dobija odobrenje da se mo\u017ee pojaviti na tr\u017ei\u0161tu\nkao lek koji se koristi u klini\u010dkoj praksi.<\/em><\/p>\t\t\t<\/div>\r\n\t\t\t

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Kako zapravo izgleda jedna klini\u010dka studija?<\/h3>\r\n\t\t\t\t

Bitno je naglasiti da je u\u010de\u0161\u0107e pacijenta u klini\u010dkoj studiji u potpunosti na dobrovoljnoj bazi, i svaki u\u010desnik potpisuje\ninformisani pristanak pre uklju\u010divanja u studiju. Pacijent ima pravo da se, u bilo kom trenutku i iz bilo kojeg razloga,\npovu\u010de iz klini\u010dke studije, bez ikakvih pravnih ili drugih posledica.<\/p>

U najve\u0107em broju slu\u010dajeva, dizajn studije je takav da su pacijenti podeljeni u dve grupe. Pacijenti u jednoj grupi\nprimaju ispitivani lek, dok pacijenti druge grupe (kontrolna grupa) primaju placebo. Placebo je farmakolo\u0161ki neaktivni\npreparat (nema nikakav efekat), koji je dizajniran da izgleda isto kao ispitivani lek i slu\u017ei da se u odnosu na njega\nproveri efikasnost leka. Tako\u0111e, studija mo\u017ee da bude dizajnirana i bez placeba, gde kontrolna grupa umesto placeba\nprima drugi lek koji je ve\u0107 na tr\u017ei\u0161tu.<\/p>

Pojedine studije su dizajnirane tako da pacijenti i istra\u017eiva\u010di ne znaju koji pacijent prima lek, a koji placebo. To\nomogu\u0107ava lekaru da objektivno analizira sve efekte novog leka i izvede pravilne zaklju\u010dke. Bez obzira na to da li prima\nispitivani lek ili placebo, svaki pacijent je tretiran podjednako, dobija istu negu, prolazi ista ispitivanja i njegova\nbezbednost je na prvom mestu.<\/p>\t\t\t<\/div>\r\n\t\t\t

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Ko mo\u017ee da u\u010destvuje u klini\u010dkim ispitivanjima?<\/h3>\r\n\t\t\t\t

Za svaku studiju postoje detaljne smernice koje govore koji pacijenti mogu da se uklju\u010de u tu studiju i potencijalni\nu\u010desnici moraju da ih ispune da bi bili uvr\u0161teni.<\/p>

Uslovi koji moraju biti ispunjeni da bi pacijent bio uvr\u0161ten u studiju se zovu kriterijumi za uklju\u010divanje. Nasuprot tome,\nsvi faktori koji mogu da spre\u010de pacijenta da bude uklju\u010den se nazivaju kriterijumi za isklju\u010denje, i dovoljno je da je\nprisutan samo jedan od njih da pacijent ne bi bio uklju\u010den.<\/p>

Primer ovih kriterijuma su godine starosti, pol, vrsta i stepen\noboljenja, podaci iz medicinske istorije pacijenta, dodatna terapija koju pacijent koristi. Svaka studija ima svoj set\nkriterijuma i svaka se sprovodi za odre\u0111eno stanje ili oboljenje. <\/p>\t\t\t<\/div>\r\n\t\t\t

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\u0160ta je informisani pristanak?<\/h3>\r\n\t\t\t\t

Pre nego \u0161to se uklju\u010di u studiju, svaki pacijent ima pravo da zna i da razume \u0161ta podrazumeva u\u010de\u0161\u0107e u studiji. Taj\nproces se naziva informisani pristanak.<\/p>


Informisani pristanak podrazumeva interaktivnu komunikaciju izme\u0111u pacijent i lekara, sa ciljem da pacijentu u\npotpunosti, na njemu razumljiv na\u010din, bude razja\u0161njeno \u0161ta sve nosi u\u010de\u0161\u0107e u studiji. To uklju\u010duje i\ninformacije o tome da li se u studiji koristi placebo i koja je verovatno\u0107a da pacijent bude u grupi koja prima placebo,\nzatim da li postoje ve\u0107 dostupni lekovi ili tretmani na tr\u017ei\u0161tu za ispitivano oboljenje, o svim potencijalnim rizicima ili\nbenefitima uklju\u010divanja u studiju. Dakle, informisani pristanak je daleko vi\u0161e od samog potpisivanja formulara.<\/p>

Potpisivanjem informisanog pristanka, pacijent potvr\u0111uje da svojom slobodnom voljom pristupa klini\u010dkoj studiji, kao i\nda je upoznat sa svim potencijalnim posledicama i benefitima koje to u\u010de\u0161\u0107e nosi. Uprkos tome, pacijent svakako ima\npravo da, u bilo kom trenutku i iz bilo kog razloga, povu\u010de svoj pristanak i napusti studiju. <\/p>\t\t\t<\/div>\r\n\t\t\t

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Zbog \u010dega se pacijenti uklju\u010duju u klini\u010dka ispitivanja?<\/h3>\r\n\t\t\t\t

Svaki pacijent ima sopstveni razlog za priklju\u010divanje studiji.\nZa neke, razlog mogu da budu razli\u010dite medicinske usluge koje su deo protokola studije, a za druge to mo\u017ee da bude\n\u0161ansa da dobiju novi lek koji bi mogao da im pomogne.<\/p>

Jo\u0161 jednom, bitno je naglasiti da je u\u010de\u0161\u0107e u studiji apsolutno na dobrovoljnoj fazi i da svaki pacijent treba da\nprodiskutuje detaljno sa svojim lekarom o svim mogu\u0107im prednostima ili posledicama uklju\u010divanja u studiju.\nMi, u MSB Centru za klini\u010dka ispitivanja, se staramo o tome da pacijent dobije sve potrebne informacije da bi doneo\ninformisanu odluku o pristupu studiji. <\/p>\t\t\t<\/div>\r\n\t\t\t

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Za vi\u0161e informacija posetite<\/h3>\r\n\t\t\t\t

ALIMS \u2013 Agencija za lekove i medicinska sredstva<\/a>
Brochure for participants and potential participants in clinical trials, by ALIMS<\/a>
EOS \u2013 Ethic committee of Serbia<\/a>\u00a0<\/p>\t\t\t<\/div>\r\n\t\t\t

\r\n\t\t\t\t\t\t\t<\/div>\r\n\t\t<\/div> \r\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

About clinical trials All the treatments and medications used regularly today were made possible by past clinical trials and the patients who participated in them. What is clinical research? A […]<\/p>\n","protected":false},"author":2,"featured_media":4067,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3470","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"\nMedical System Belgrade | Serbia Clinical Research | MSB CRC<\/title>\n<meta name=\"description\" content=\"Medical System Belgrade, specialized clinical research center in Serbia. New drugs and medication research. Phase 1-4 studies. 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