Original Research
Sunday, November 12, 2023
12:45 PM–02:15 PM
Abstract
Introduction: Over one million U.S. adults are transgender or gender diverse (TGD), yet gender diversity in clinical drug trials is limited.
Research Question or Hypothesis: How many drug trials in ClinicalTrials.gov included TGD people and what are the trial characteristics over the past 15 years?
Study Design: Retrospective cross-sectional cohort study using publicly available clinical trial records on ClinicalTrials.gov.
Methods: A static copy of the ClinicalTrials.gov database was downloaded from the Clinical Trials Transformation Initiative on January 28, 2023. We included interventional trials with a primary purpose of treatment registered between October 1, 2007 (the date FDA required registration of interventional trials) and the download date. To identify trials inclusive of TGD people, we reviewed study titles, keywords, and eligibility criteria. Two researchers reviewed the studies to ensure they included TGD people; a third investigator adjudicated discrepancies. We grouped studies by year of registration: October 2007-December 2015 (“early”) and January 2016-January 2023 (“late”). We investigated recruitment status, eligible ages and gender identities, sample sizes and therapeutic areas for each trial. Descriptive statistics were used to summarize trial characteristics. Characteristics were reported as frequencies and percentages. Statistical comparisons utilized Fisher’s exact test with p<0.05 considered significant.
Results: 189,249 interventional trials were registered between October 2007-January 2023; 84 trials included TGD participants, of which 28 were drug trials (2 early; 26 late). In the early vs. late groups, 2 (100%) vs. 3 (11.5%) trials completed recruitment (p=0.03); 2 (100%) vs. 25 (96.2%) enrolled adults (=18 years, p=0.9); 1 (50.0%) vs. 13 (50.0%) enrolled all gender identities (p=0.9); 1 (50.0%) vs. 11 (42.3%) enrolled >100 participants (p=0.9). HIV prevention and treatment was the most common therapeutic area in the late vs. early group (8 [30.8%] vs. 0, p=0.9).
Conclusion: Trials inclusive of TGD people have increased markedly over the past 15 years. This trend was related to increased HIV prevention and treatment trials.
Presenting Author
Zachary Schonrock BA, PharmD candidateUniversity of Washington
Authors
Lauren Cirrincione Pharm.D, MPH
University of Washington
Kikka Delarose BA
Univerisity of Washington