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Demographic Composition of Select Oncologic New Molecular Entities Approved by the FDA Between 2008 and 2017
Author(s) -
Ramamoorthy Anuradha,
Knepper Todd C.,
Merenda Christine,
Mendoza Martin,
McLeod Howard L.,
Bull Jonca,
Zhang Lei,
Pacanowski Michael
Publication year - 2018
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1180
Subject(s) - medicine , food and drug administration , composition (language) , drug approval , pharmacology , drug , philosophy , linguistics
Race, ethnicity, sex, and age are demographic factors that can influence drug exposure and/or response, and can consequently affect treatment outcome. We evaluated demographic subgroup enrollment patterns in new therapeutic products approved by the US Food and Drug Administration ( FDA ) for the treatment of select cancers—breast, colorectal, lung, and prostate—that have comparative differences in morbidity and/or mortality among some demographic subgroups. In submissions of products approved between 2008 and 2013, participants ( n = 22,481) were white (80%), from outside the United States (74%), between 17 and 64 years old (59%), and men (56% and 53%, including and excluding sex‐specific indications, respectively). In pivotal trials of products approved between2014 and 2017, participants ( n = 3,612) were white (71%), between 17 and 64 years old (61%), and men (48% and 63%, including and excluding sex‐specific indications, respectively). The US‐relevant minority populations were under‐represented. A broader representation of patient subgroups in clinical trials may contribute to better understanding of exposure and/or response variability, and consequently help personalize drug therapy.