Author/Editor		Ocaña, Alberto; Amir, Eitan; Vera-Badillo, Francisco; Šeruga, Boštjan; Tannock, Ian
Title		Phase III trials of targeted anticancer therapies
Type		članek
Vol. and No.		Letnik 19, št. 18
Publication year		2013
Volume		str. 4931-4940
ISSN		1078-0432 - Clinical cancer research : an official journal of the American Association for Cancer Research
Language		eng
Abstract		Randomized phase III trials provide the gold-standard evidence for the approval of new drugs: an experimental treatment is compared with the current standard of care to identify clinically relevant differences in a predefined endpoint. However, there are several problems relating to the current role of phase III trials in drug development including the limited clinical benefit observed for some approved agents, the necessity for large trials to detect these differences, the inability of such trials to identify rare but important toxicities, and high cost. The design of phase III trials evaluating drug combinations, and those including biomarkers, presents additional challenges. Here, we review these problems and suggest that phase III trials with adaptive designs in selected prescreened populations could reduce these limitations.
Keywords		randomizirane klinične študije tarčno zdravljenje zdravila kemoterapija randomized clinical trials targeted anticancer therapies drugs