Evidence map›Paper›PMID 29048983›Full record

ArticleJournal of women's health (2002)2018

Representation of Women and Minorities in Clinical Trials for New Molecular Entities and Original Therapeutic Biologics Approved by FDA CDER from 2013 to 2015.

Alice Chen, Hilary Wright, Hawi Itana, Merina Elahi, Ayomide Igun, Guoxing Soon, Anne R Pariser, Emmanuel O Fadiran

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of women's health (2002), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
–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

21 citing papers in PubMed.

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  11. Demographic representation in clinical trials for cell-based therapy.Contemporary clinical trials communications · 2021
    Article
  12. Paying for Fairness? Incentives and Fair Subject Selection.The American journal of bioethics : AJOB · 2021
    Article
  13. Article
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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.

Alice Chen1 Office of Translational Sciences, Center for Drug Evaluation and Research , Food and Drug Administration, Silver Spring, Maryland.
Hilary Wright2 Office of Women's Health, Office of the Commissioner, Food and Drug Administration , Silver Spring, Maryland.
Hawi Itana2 Office of Women's Health, Office of the Commissioner, Food and Drug Administration , Silver Spring, Maryland.
Merina Elahi2 Office of Women's Health, Office of the Commissioner, Food and Drug Administration , Silver Spring, Maryland.
Ayomide Igun2 Office of Women's Health, Office of the Commissioner, Food and Drug Administration , Silver Spring, Maryland.
Guoxing Soon1 Office of Translational Sciences, Center for Drug Evaluation and Research , Food and Drug Administration, Silver Spring, Maryland.
Anne R Pariser1 Office of Translational Sciences, Center for Drug Evaluation and Research , Food and Drug Administration, Silver Spring, Maryland.
Emmanuel O Fadiran2 Office of Women's Health, Office of the Commissioner, Food and Drug Administration , Silver Spring, Maryland.

Funding

Intramural NIH HHS Z99 TR999999
6 · The paper itself

Abstract

backgroundThe U.S. Food and Drug Administration (FDA) has made efforts to encourage adequate assessment of women, racial/ethnic minorities, and geriatric participants in clinical trials through regulations and guidance documents. This study surveyed the demographics of clinical trial participants and the presence of efficacy and safety analyses by sex for new drugs approved between 2013 and 2015 by the FDA Center for Drug Evaluation and Research.

methodsNew drug marketing applications submitted to FDA were surveyed for demographic data (sex, race, ethnicity, and age) and the presence of sex-based analyses for efficacy and safety. The Ratio of the Proportion of women in clinical trials for the indicated disease population relative to the estimated Proportion of women in the disease population (PPR) was calculated for new drug indications.

resultsOf the 102 new drugs in this cohort (defined as new molecular entity drugs and original therapeutic biologics), sex was reported for >99.9% of trial participants, and women accounted for 40.4% of these participants. An estimated 77.2% of participants were White, 6.4% were Black/African American, and 29.1% were aged ≥65 years. Sex-based analyses for both efficacy and safety were conducted for 93.1% of applications. PPR was calculated for 82 new drugs for a total of 60 indications, of which 50 indications (83.3%) had a PPR ≥0.80.

conclusionsSex data are now collected for almost all study participants, and this study shows appropriate sex participation for most new drugs when estimated disease prevalence by sex (PPR) is considered. Therapeutic area and disease indication are important considerations when assessing the sex of participants because variation occurs depending on the disease under study. Some racial minorities, especially Blacks/African Americans, are still not well represented in most drug development programs and remain an area where improvement is needed.

Indexed as

Clinical Trials as TopicMinority GroupsPatient SelectionBiological ProductsDrug ApprovalEthnicityFemaleHumansUnited StatesUnited States Food and Drug AdministrationBiological Productsclinical trialdemographysex distributionUnited States Food and Drug Administration (FDA)

Identifiers

PMID29048983
PMCPMC7001461

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.