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Incorporating Transgender and nonbinary Participants in Phase 1 Clinical Drug Trials: Current Knowledge Gaps and Considerations for Phase 1 Studies
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  • Lauren Walker,
  • Michael Stackpoole,
  • Daryl Hodge,
  • Richard FitzGerald
Lauren Walker
University of Liverpool

Corresponding Author:[email protected]

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Michael Stackpoole
Liverpool University Hospitals NHS Foundation Trust
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Daryl Hodge
University of Liverpool
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Richard FitzGerald
University of Liverpool
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Phase 1 clinical drug trials critically depend on the participation of healthy volunteers to evaluate the safety and pharmacokinetics of new medicinal products. Current selection criteria and health definitions often overlook the unique health profiles of transgender and nonbinary individuals, potentially excluding them from participating in these essential early-stage studies. This review aims to identify and discuss current knowledge gaps and considerations regarding the inclusion of transgender and nonbinary participants in Phase 1 clinical drug trials. We highlight the need for research on how gender-affirming hormone therapy may affect drug pharmacokinetics and call for the development of inclusive biological reference ranges that account for the physiological effects of hormone therapies.
05 Feb 2024Submitted to British Journal of Clinical Pharmacology
08 Feb 2024Submission Checks Completed
08 Feb 2024Assigned to Editor
08 Feb 2024Review(s) Completed, Editorial Evaluation Pending
10 Feb 2024Reviewer(s) Assigned
28 Feb 2024Editorial Decision: Revise Minor
29 Feb 20241st Revision Received
01 Mar 2024Assigned to Editor
01 Mar 2024Submission Checks Completed
01 Mar 2024Review(s) Completed, Editorial Evaluation Pending
02 Mar 20242nd Revision Received
05 Mar 2024Assigned to Editor
05 Mar 2024Submission Checks Completed
05 Mar 2024Review(s) Completed, Editorial Evaluation Pending