Evidence map›Paper›PMID 38710989›Full record

ArticleBritish journal of clinical pharmacology2024

Transgender people in clinical trials of drugs and biologics: An analysis of ClinicalTrials.gov from 2007 to 2023.

Zachary Schonrock, Sierra Brackeen, Kikka E Delarose, Tiffany Q-D Tran, Lauren R Cirrincione

Abstract read
In one paragraph

Article in British journal of clinical pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Review
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

5 authors.

Zachary SchonrockDepartment of Pharmacy, University of Washington, Seattle, Washington, USA.ORCID https://orcid.org/0000-0001-9643-3588
Sierra BrackeenDepartment of Pharmacy, University of Washington, Seattle, Washington, USA.
Kikka E DelaroseDepartment of Pharmacy, University of Washington, Seattle, Washington, USA.
Tiffany Q-D TranDepartment of Pharmacy, University of Washington, Seattle, Washington, USA.
Lauren R CirrincioneDepartment of Pharmacy, University of Washington, Seattle, Washington, USA.ORCID https://orcid.org/0000-0002-9115-1060

Funding

Transform Dissemination and Implementation Science in CTSA ProgramsUL1TR002319 · NCATS · UNIVERSITY OF WASHINGTON · PI John K. Amory · 2017 to 2026
$100.0M
Hormone mediated mechanisms of altered drug metabolism and transport in transgender adultsK23GM147350 · NIGMS · UNIVERSITY OF WASHINGTON · PI CIRRINCIONE, LAUREN · 2022 to 2025
$748k
American College of Clinical PharmacyNCATS NIH HHS UL1 TR002319NIGMS NIH HHS K23 GM147350NIGMS NIH HHS K23GM147350NIH HHS
6 · The paper itself

Abstract

aimsTransgender people have unmet health needs related to chronic conditions such as dementia, osteoporosis and hypertension. Community-driven advocacy increased transgender representation in phase III trials for pharmacological prevention of HIV, but the extent to which drug trials for other conditions have included transgender people is unknown. We investigated the extent to which trials of drugs and biologics represented transgender people across therapeutic areas on ClinicalTrials.gov.

methodsCross-sectional analysis of trials of drugs and biologics registered on ClinicalTrials.gov from 2007-2023. We included efficacy and effectiveness trials (phase II-IV) with transgender-related terms (e.g. 'transgend*'). We labelled trials as Inclusive or Exclusive of transgender people using the trial eligibility criteria. We compared trials (therapeutic area, trial design, enrolment), summarized trials registered from 2008 onward and characterized participant enrolment for Inclusive trials with primary trial publications. We summarized continuous data using median (range), categorical data using frequencies and percentages and compared trial characteristics using Fisher's exact test.

resultsNinety-seven trials represented transgender people. Characteristics were similar between 85 Inclusive and 12 Exclusive trials. Among Inclusive trials, 58% focused on infectious diseases (e.g. treatment or prevention of HIV and COVID-19), 15% on mental health (e.g. post-traumatic stress disorder, substance use-related disorders), and the remainder focused on endocrine (9%), pain (5%), digestive system disorders (1%) and neoplasms (1%). Twenty (of 25) trials reported enrolment of transgender participants in primary trial publications or reported results.

conclusionTransgender-inclusive trials have increased since 2008. Most trials focused on infectious diseases and mental health. Investigators should increase opportunities to include of transgender people in trials of drugs and biologics for chronic diseases.

Indexed as

Biological ProductsClinical Trials as TopicTransgender PersonsCross-Sectional StudiesFemaleHumansMalePatient SelectionBiological Productsclinical trialsdiversityphase II–IV trialstransgender people

Identifiers

PMID38710989
PMCPMC12145575

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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.