Evidence map›Paper›PMID 32123487›Full record

ArticleCritical public health2020

Disadvantaged, Outnumbered, and Discouraged: Women's Experiences as Healthy Volunteers in U.S. Phase I Trials.

Nupur Jain, Marci D Cottingham, Jill A Fisher

Open access · greenAbstract read
In one paragraph

Article in Critical public health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.8field-weighted citation impact, top 14% of its field
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

9 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Paving the way towards medicines for women and men.European journal of clinical pharmacology · 2024
    Article
  3. Article
  4. Article
  5. Article
  6. Paying for Fairness? Incentives and Fair Subject Selection.The American journal of bioethics : AJOB · 2021
    Article
  7. Article
  8. Article
  9. Article
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

3 authors at 2 institutions in 2 countries.

Nupur JainThe Gillings School of Global Public Health, University of North Carolina at Chapel Hill, USA, nupurn@live.unc.edu.
Marci D CottinghamDepartment of Sociology, University of Amsterdam, Netherlands, M.D.Cottingham@uva.nl.
Jill A FisherDepartment of Social Medicine and Center for Bioethics, University of North Carolina at Chapel Hill, USA.
University of North Carolina at Chapel Hill · USUniversity of Amsterdam · NL

Funding

Healthy Volunteers as Model Organisms: Comparative Research Ethics and Policy for Phase I trialsR01GM099952 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FISHER, JILL A, WALKER, REBECCA · 2012 to 2020
$3.6M
NIGMS NIH HHS R01 GM099952
6 · The paper itself

Abstract

While enormous strides have been made in the representation of women in clinical trials, the percentage of women enrolling in Phase I trials still remains low, which both raises public health concerns about the safety of new drugs and social justice concerns regarding their inclusion in research. As part of a longitudinal study of healthy volunteers in the United States, our inquiry aimed to examine impediments to women enrolling in Phase I trials as well as their experiences participating in these studies at residential research clinics. We analyzed 111 semi-structured interviews conducted with 47 women who had enrolled in at least one Phase I trial. Our study indicates that women face discrimination during all stages of their participation in Phase I trials from their ability to qualify for studies, the treatment they receive in the clinic facilities, and a lack of social support. Specifically, we found that (1) study designs disadvantage participants of childbearing potential, (2) women feel vulnerable in the clinic space when outnumbered by men, and (3) heterosexual women are often discouraged from participation by their husbands or significant others. Placing these findings within the scholarly literature on barriers to women's clinical trial participation, we argue that diverse strategies attending both to physiological and social factors are needed to combat inequalities in U.S. Phase I trial participation.

Indexed as

clinical trial inclusiondiscriminationgender inequalityhealthy volunteerswomen

Identifiers

PMID32123487
PMCPMC7050919
OpenAlexW2896627315

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.