Incorporating Transgender and nonbinary Participants in Phase 1 Clinical
Drug Trials: Current Knowledge Gaps and Considerations for Phase 1
Studies
- Lauren Walker
, - Michael Stackpoole,
- Daryl Hodge,
- Richard FitzGerald
Michael Stackpoole
Liverpool University Hospitals NHS Foundation Trust
Author ProfileAbstract
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 2024Submission Checks Completed
01 Mar 2024Assigned to Editor
01 Mar 2024Review(s) Completed, Editorial Evaluation Pending
02 Mar 20242nd Revision Received
05 Mar 2024Submission Checks Completed
05 Mar 2024Assigned to Editor
05 Mar 2024Review(s) Completed, Editorial Evaluation Pending