POBOLJŠANJE REGULATIVE ZA KLINIČKO ISPITIVANJE ANTIEPILEPTIKA
Sažetak
Uvod: Klinički razvoj antiepileptika je zahtevan process zbog kompleksnog karaktera epilepsije, njenih različitih oblika i etiologije.
Cilj: Cilj ovog preglednog članka je da ukaže na moguća poboljšanja regulative kliničkog razvoja antiepileptika.
Metod: Sledeće baze podataka su pretražene: MEDLINE, SCOPUS i SCINDEKS. Ukupno je pronađeno 558 publikacija iz kategorija pregledni članak, klinička studija i pismo autoru.
Rezultati: Postoji nekoliko promena regulative koje su neophodne za poboljšanje procesa kliničkog razvoja antiepileptika: u studijama gde se novi antiepileptik nadodaje na postojeću terapiju treba obavezno primeniti dizajn sa paralelnim grupama; u dizajnu studija sa monoterapijom treba da bude prihvatljiv cilj dokazati da novi lek nije manje efikasan od komparatora; restrikcije vezane za kliičke studije na deci treba ublažiti; agencije za lekove S.A.D. i Evropske unije treba da usklade zahteve u pogledu mera efikasnosti antiepileptika; stav prema otkrivanju neželjenih dejstava novih lekova treba da bude proaktivan; zahtevi za studije u kojima se dokazuje antiepileptogeni efekat treba da budu jasniji.
Zaključak: Potojeća regulative je u mnogo čemu nekompletna; neophodan je međunarodni napor da se poboljšaju i harmonizuju vodiči za klinički razvoj antiepileptika kako bi se taj process poboljšao.
Reference
Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders. European Medicines Agency, 22 July 2010, CHMP/EWP/566/98 Rev.2/Corr, Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070043.pdf, [Last accessed 22 February 2015].
Guidelines for the Clinical Evaluation of Antiepileptic Drugs (Adults and Children). U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071582.pdf, [Last accessed 22 February 2015].
Schmidt B. Clinical development of antiepileptic drugs in adults. Neurotherapeutics 2007; 4(1): 62-9.
Faught E. Antiepileptic drug trials: the view from the clinic. Epileptic Disord 2012; 14(2): 114-23.
Garofalo E. Clinical development of antiepileptic drugs for children. Neurotherapeutics 2007; 4(1): 70-4.
MEDLINE database of scientific articles; Available at: http://www.ncbi.nlm.nih.gov/pubmed, [Last accessed 4. June 2015].
SCOPUS database of scientific articles; available at: http://www-scopus-com.proxy.kobson.nb.rs:2048/, [Last accessed 4. June 2015].
SCINDEKS database of medical journals,available at: http://scindeks.ceon.rs/?lang=en, [Last accessed 4. June 2015].
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