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Differences between a drug regimen employed in early phase 1 trials and the subsequent use of the agent in routine oncologic practice
Author(s) -
Markman Maurie
Publication year - 2007
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.22967
Subject(s) - medicine , clinical trial , regimen , intensive care medicine , drug , clinical practice , population , phases of clinical research , phase (matter) , oncology , medical physics , pharmacology , family medicine , environmental health , chemistry , organic chemistry
It is reasonable to assume that a decision to permit wider access to new anticancer agents after the completion of only phase 1 trials will almost certainly result in the administration of such therapy to a substantial population of individuals who would not have been eligible for such “registration‐type” testing. However, the optimal use of antineoplastic agents in routine clinical practice may differ substantially from the doses and schedules examined in phase 1 clinical trials.