Title Phase IV clinical trials
Title (croatian) Klinička ispitivanja faze IV
Author Armin Hadrys
Mentor Robert Likić (mentor)
Committee member Robert Likić (predsjednik povjerenstva)
Committee member Boško Skorić (član povjerenstva)
Committee member Srećko Marušić (član povjerenstva)
Granter University of Zagreb School of Medicine (Department of Internal Medicine) Zagreb
Defense date and country 2021-07-16, Croatia
Scientific / art field, discipline and subdiscipline BIOMEDICINE AND HEALTHCARE Clinical Medical Sciences Clinical Pharmacology and Toxicology
Abstract A phase IV clinical trial is an important step in the surveillance of a new drug after its approval for release on the market. It is an essential part of post-marketing research that focuses on realworld effectiveness and pharmacovigilance, thus not only continuing previous studies, but complementing them. Phase IV clinical trials differ significantly in their study design, their requirements, and their scientific demand from previous study phases. Phases I to III mainly examine the safety profile of the drug on a smaller scale, as well as the drug’s efficacy in a controlled environment of an RCT. Contrarily, phase IV studies claim to uncover even rarer ADRs that could have been overlooked in previous studies and also inspect whether the new drug proves its worth on the free market, in interaction with other drugs and in population groups that had not been previously admitted to the study. The aim of this article is to set phase IV clinical trials in conjunction with the previous preclinical trials to get a bigger picture of the long path a drug takes—not only until its release on the market, but also after its commercialization. Other goals are to show the relation with different parts of post-marketing research, to investigate the modern role of phase IV studies, and to research the extent to which the current status of phase IV clinical trials meets requirements.
Abstract (croatian) Klinička ispitivanja faze IV važan su korak u nadzoru novog lijeka, a nakon što je odobreno njegovo plasiranje na tržište.
Klinička ispitivanja faze IV bitan su dio istraživanja lijekova u njihovoj postmarketinškoj fazi (nakon dolaska lijeka na tržište), a usmjerena su na stvarnu učinkovitost i farmakovigilanciju, te stoga, ne samo da nastavljaju prethodna ispitivanja, već ih
nadopunjuju. Značajno se razlikuju u načinu ispitivanja, zahtjevima i znanstvenoj potražnji u odnosu na prethodna ispitivanja, koja su uglavnom ispitala sigurnosni profil lijeka u manjoj mjeri, kao i djelotvornost lijeka u kontroliranom okruženju RCT-a. S druge strane, ispitivanja faze IV, za koja se tvrdi da otkrivaju rijetke nuspojave, mogla bi biti zanemarena u prethodnim ispitivanjima i istraživanju na koji način novi lijek pokazuje svoju vrijednost na slobodnom tržištu u interakciji s drugim lijekovima i populacijskim skupinama, koje prethodno nisu bile uključene u ispitivanje. Cilj rada je postaviti klinička ispitivanja faze IV u vezu zajedno s prethodnim pretkliničkim ispitivanjima, kako bi se dobila veća slika dugog puta kojim lijek prolazi - ne samo do trenutka njegova plasiranja na tržište - već i nakon komercijalizacije. Također, rad objašnjava odnos s drugim dijelovima postmarketinškog istraživanja, analizira ulogu ispitivanja faze IV i pokazuje u kojoj mjeri trenutačni status kliničkih ispitivanja faze IV ispunjava njihove zahtjeve.
Keywords
phase IV clinical trials
post-marketing research
ADR
preclinical trials
pharmacovigilance
large simple trials
external validity
Keywords (croatian)
klinička ispitivanja faze IV
postmarketinško istraživanje
nuspojave
pretklinička ispitivanja
farmakovigilancija
velika jednostavna ispitivanja
vanjska valjanost
Language english
URN:NBN urn:nbn:hr:105:751986
Study programme Title: Medicine (in English language) Study programme type: university Study level: integrated undergraduate and graduate Academic / professional title: doktor/doktorica medicine (doktor/doktorica medicine)
Type of resource Text
File origin Born digital
Access conditions Open access
Terms of use
Created on 2021-12-22 12:29:56