Dataset Information

Demographic Composition of Select Oncologic New Molecular Entities Approved by the FDA Between 2008 and 2017.

ABSTRACT: 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.

SUBMITTER: Ramamoorthy A

PROVIDER: S-EPMC6220929 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Demographic Composition of Select Oncologic New Molecular Entities Approved by the FDA Between 2008 and 2017.

Ramamoorthy Anuradha A Knepper Todd C TC Merenda Christine C Mendoza Martin M McLeod Howard L HL Bull Jonca J Zhang Lei L Pacanowski Michael M

Clinical pharmacology and therapeutics 20180914 5

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 betw ...[more]

PMID: 30218447

Similar Datasets

Project description:BackgroundMedication guides are required documents to be distributed to patients in order to convey serious risks associated with certain prescribed medicines. Little is known about the effectiveness of this information to adequately inform patients on safe use.ObjectiveTo examine the readability, suitability, and comprehensibility of medication guides, particularly for those with limited literacy.DesignAssessments of suitability and readability of 185 medication guides, and a sub-study examining change in suitability and readability from 2006 to 2010 among 32 of the medication guides (Study 1); 'open book' comprehension assessment of medication guides (Study 2).SettingTwo general internal medicine clinics in Chicago, IL.PatientsFour hundred and forty-nine adults seeking primary care services, ages 18-85.MeasurementsFor Study 1, the Suitability Assessment of Materials (SAM) and Lexile score for readability. For Study 2, a tailored comprehension assessment of content found in three representative medication guides.ResultsThe 185 analyzed medication guides were on average 1923 words (SD = 1022), with a mean reading level of 10-11th grade. Only one medication guide was deemed suitable in SAM analyses. None provided summaries or reviews, or framed the context first, while very few were rated as having made the purpose evident (8 %), or limited the scope of content (22 %). For Study 2, participants' comprehension of medication guides was poor (M = 52.7 % correct responses, SD = 22.6). In multivariable analysis, low and marginal literacy were independently associated with poorer understanding (β = -14.3, 95 % CI -18.0 - -10.6, p < 0.001; low: β = -23.7, 95 % CI -28.3 - -19.0, p < 0.001).ConclusionCurrent medication guides are of little value to patients, as they are too complex and difficult to understand especially for individuals with limited literacy. Explicit guidance is offered for improving these print materials.

Dataset Information

Demographic Composition of Select Oncologic New Molecular Entities Approved by the FDA Between 2008 and 2017.

Publications

Demographic Composition of Select Oncologic New Molecular Entities Approved by the FDA Between 2008 and 2017.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets