Incorporating transgender and nonbinary participants in phase 1 clinical drug trials: Current knowledge gaps and...

Area of Science:

• Clinical pharmacology
• Health equity
• Transgender health

Background:

• Phase 1 clinical trials are crucial for evaluating new drug safety and pharmacokinetics.
• Healthy volunteers are essential for these early-stage drug development studies.
• Current participant selection criteria may inadvertently exclude transgender and nonbinary individuals.

Purpose of the Study:

• To identify knowledge gaps regarding the inclusion of transgender and nonbinary individuals in phase 1 clinical trials.
• To discuss considerations for the safe and effective inclusion of diverse populations in early drug development.
• To advocate for research into the impact of gender-affirming hormone therapy on drug pharmacokinetics.

Main Methods:

• Literature review of current practices in phase 1 clinical trial recruitment.
• Analysis of existing health definitions and selection criteria for potential biases.
• Identification of areas requiring further research concerning transgender and nonbinary participants.

Main Results:

• Current selection criteria and health definitions often do not accommodate the unique physiological profiles of transgender and nonbinary individuals.
• There is a lack of research on how gender-affirming hormone therapy influences drug pharmacokinetics.
• Existing biological reference ranges may not be appropriate for all participants.

Conclusions:

• Inclusive practices are necessary to ensure equitable participation in phase 1 clinical trials.
• Further research is needed to understand the pharmacokinetic implications of gender-affirming hormone therapy.
• Development of inclusive biological reference ranges is critical for accurate health assessments in diverse populations.