Introduction: The transgender and non-binary communities make up a significant, growing proportion of the population, but, to date, few clinical trials report including transgender and non-binary individuals.
Methods: As part of a mixed-method approach, multiple literature searches for articles published from January 2018 to July 2022 and a Patient Advisory Council (a semi-structured patient focus group) meeting were conducted to identify challenges faced by the transgender and non-binary communities when accessing healthcare and participating in clinical research. A set of guidelines to promote inclusivity in clinical research was developed using these findings.
Results: During this time period, only 107 (0.08%) of 141,661 published articles of clinical trials reported participation of transgender or non-binary patients. A targeted search identified only 48 articles reporting specific barriers to inclusion in clinical research, while an expanded search identified 290 articles reporting barriers to healthcare access for transgender and non-binary patients. Several key considerations to promote study inclusivity emerged from the literature searches and Patient Advisory Council: adjust clinical protocols, informed consent documents, and data collection forms to distinguish sex assigned at birth from gender identity; involve members of the transgender and non-binary communities in research whenever possible; provide communication training to personnel involved in clinical research; and maximize accessibility for potential participants.
Conclusion: Future research on investigational drug dosing and drug interactions in transgender and non-binary patients, along with regulatory guidance, are recommended to ensure clinical trials' processes, designs, systems, and technologies are transgender and non-binary patient-friendly, inclusive, and welcoming.
Keywords: Clinical research; Clinical trial; Inclusion; Non-binary; Transgender.
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