Evidence map›Paper›PMID 30218447›Full record

ArticleClinical pharmacology and therapeutics2018

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

Anuradha Ramamoorthy, Todd C Knepper, Christine Merenda, Martin Mendoza, Howard L McLeod, Jonca Bull, Lei Zhang, Michael Pacanowski

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical pharmacology and therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Anuradha RamamoorthyOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
Todd C KnepperMoffitt Cancer Center, Tampa, Florida, USA.ORCID 0000-0001-7651-2406
Christine MerendaOffice of Minority Health, Office of the Commissioner, FDA, Silver Spring, Maryland, USA.
Martin MendozaOffice of Minority Health, Office of the Commissioner, FDA, Silver Spring, Maryland, USA.
Howard L McLeodMoffitt Cancer Center, Tampa, Florida, USA.ORCID 0000-0002-9004-9232
Jonca BullOffice of Minority Health, Office of the Commissioner, FDA, Silver Spring, Maryland, USA.
Lei ZhangOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
Michael PacanowskiOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Patient SelectionAdolescentAdultAgedAge DistributionAntineoplastic AgentsClinical Trials as TopicDrug ApprovalDrug LabelingFemaleHumansMaleMiddle AgedPatient SafetyRacial GroupsResearch SubjectsAntineoplastic Agents

Identifiers

PMID30218447
PMCPMC6220929

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.