Clinical research has historically relied on binary sex and gender classifications, leaving transgender and non-binary individuals underrepresented and underserved. This exclusion creates gaps in safety, efficacy, and dosing data, undermining both scientific accuracy and health equity. From outdated intake forms to a lack of pharmacokinetic studies that account for hormone therapy, structural and cultural barriers persist across the research enterprise. But efforts from agencies like the NIH and inclusive trial designs are beginning to pave the way for change. Moving beyond the binary requires systemic reform, stakeholder accountability, and a commitment to treating gender-diverse individuals not as exceptions, but as essential participants in the future of clinical research.
Introduction: The False Binary of Clinical Research
For decades, clinical research has operated under a binary framework that classifies participants strictly as male or female, both in biological and gender terms. This approach, long considered a practical simplification, has come under increasing scrutiny for its failure to reflect the full spectrum of human gender diversity. By defaulting to this binary model, clinical trials systematically exclude or marginalize transgender (trans) and non-binary individuals, resulting in both scientific blind spots and ethical oversights.
The implications are far-reaching. When trans and non-binary people are not adequately represented in clinical studies, the resulting data may fail to capture how different bodies metabolize drugs, experience side effects, or respond to interventions. This exclusion can also perpetuate broader inequities in health outcomes, as treatments are developed, approved, and prescribed based on incomplete or non-representative data sets. Moreover, when people’s lived experiences and identities are erased from research frameworks, it undermines trust and disincentivizes participation in future studies.
These challenges are not merely theoretical. As gender-affirming care and gender-diverse identities become more visible in clinical settings, the urgency of addressing the gaps in research design grows. Current practices — ranging from binary-only intake forms to trial eligibility criteria that fail to account for people undergoing hormone therapy — do not just risk excluding participants; they risk producing knowledge that is inaccurate or inapplicable for significant portions of the population.
True equity in clinical research requires more than token gestures or diversity checkboxes. It demands structural changes in how studies are designed, cultural shifts in how research teams engage with gender-diverse communities, and scientific adaptations to how sex and gender are operationalized in biomedical inquiry.
Understanding the Stakes: Biology, Identity, and Inequity
To understand the full cost of excluding trans and non-binary individuals from clinical research, we must examine the intersection of biology, identity, and structural inequity. These dimensions are not abstract — they manifest in real consequences for health, access, and outcomes. Clinical research, if designed inclusively, has the potential to mitigate disparities. If not, it risks reinforcing them.
Biological Variation
Pharmacokinetics — the way a body absorbs, distributes, metabolizes, and excretes a drug — is a foundational consideration in determining the safety and efficacy of therapeutics. Yet most clinical trials still treat sex and gender as interchangeable and binary. For trans individuals undergoing gender-affirming hormone therapy, this simplification leads to significant gaps. Estrogen and anti-androgen therapies, for example, alter lipid metabolism, body fat distribution, and liver enzyme activity. These physiological changes may influence how drugs are processed and tolerated, but they are rarely accounted for in study designs or subgroup analyses.1,2
This oversight is not due to a lack of biological rationale. Emerging studies have shown that testosterone and estrogen can impact cytochrome P450 enzyme systems and renal clearance rates, potentially requiring different dosing or monitoring protocols.3 Trans people who have undergone gender-affirming surgeries may also have unique anatomical considerations — such as the absence or presence of specific organs — that affect inclusion criteria or risk assessments. Still, these populations are often excluded from trials entirely or enrolled without any specific attention to their medical context.4 This leaves a critical evidence gap in understanding how medications interact with trans bodies, which in turn limits physicians’ ability to deliver safe and informed care.
Social and Psychological Determinants
The exclusion of trans and non-binary individuals is not limited to protocol language or eligibility criteria — it extends into the lived experience of healthcare. Medical settings have historically been sources of trauma for gender-diverse individuals. In clinical trials, this can manifest as misgendering, invasive questions unrelated to the study, a lack of appropriate restroom facilities, or simply being made to feel unwelcome or unsafe. Such experiences are not isolated; they are widely reported across healthcare systems and create lasting mistrust.5,6
This mistrust is compounded by other axes of marginalization. Trans people of color, particularly Black and Indigenous individuals, are more likely to face intersecting forms of discrimination, economic hardship, and barriers to healthcare access. Rural trans individuals often lack access to gender-affirming providers or transportation to reach trial sites.7,8 These factors reduce the likelihood that trans and non-binary people will participate in trials — not because they are unwilling, but because systems have not been built to include or protect them. This exclusion becomes self-reinforcing: their absence in the data makes them invisible in care models, which further erodes trust and participation.
Impact on Health Outcomes
Health disparities affecting trans and non-binary individuals are well documented. Rates of depression, anxiety, substance use, HIV, and chronic disease are disproportionately high — not due to inherent vulnerability, but due to structural discrimination and lack of tailored care. When these individuals are excluded from research, it exacerbates the invisibility that underlies those disparities. Clinical guidelines are based on aggregated trial data that often do not reflect their bodies, their identities, or their experiences.
Inappropriate dosing or contraindicated treatments are more than hypothetical risks — they can result in adverse outcomes, treatment failure, or disengagement from care altogether. For instance, a trans man on testosterone therapy may experience different side effects from a psychiatric medication than a cisgender woman, yet he is unlikely to be represented in the trial data informing that prescription. This kind of mismatch contributes to poorer outcomes over time.9,10
Ultimately, when clinical research fails to reflect the real diversity of the populations it aims to serve, it loses both scientific integrity and moral legitimacy. For trans and non-binary people, this failure means living in a system that rarely sees them, rarely hears them, and rarely serves them well. Until that changes, the inequities embedded in biomedical research will continue to echo across the broader healthcare landscape.
Barriers to Inclusion in Clinical Trials
Despite increasing recognition of the need for diversity in clinical research, significant structural, procedural, and cultural barriers continue to exclude trans and non-binary individuals from participation. These barriers operate at multiple levels — from institutional infrastructure and regulatory ambiguity to everyday interpersonal interactions between research staff and potential participants. Together, they form a web of exclusion that hinders equitable representation and compromises the scientific value of clinical trials.
Institutional and Systemic Obstacles
At the most basic level, many clinical trial protocols and associated systems are built on binary assumptions about sex and gender. Intake forms, electronic health records (EHRs), and case report forms typically offer only “male” or “female” as options, failing to account for people whose gender identity or biological characteristics do not align with those categories. This omission not only forces participants to misidentify themselves or opt out entirely, but also eliminates the possibility of collecting accurate data about gender-diverse populations.11
Even when trial documentation is updated to allow more inclusive self-identification, the underlying study design may still exclude trans and non-binary individuals through indirect means. For instance, eligibility criteria that rely on assumptions about reproductive potential or sex-specific anatomy can inadvertently disqualify participants who do not fit expected norms. A trial that excludes “women of childbearing potential” unless they are on contraception, for example, may not consider how this applies to trans men or non-binary individuals who retain fertility but do not identify as female. In many cases, these exclusions are rooted in outdated assumptions rather than actual risk, and they reflect a failure to design trials around the reality of human diversity.12
Compounding these challenges is the lack of clear regulatory guidance or enforcement mechanisms to ensure inclusion of gender-diverse participants. While regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have taken steps to mandate diversity action plans, their language has largely focused on race and ethnicity, with limited attention to gender identity. In 2023, the FDA quietly withdrew a draft guidance on improving diversity in clinical trials following a broader rollback of federal diversity, equity, and inclusion (DEI) initiatives, raising concerns about the agency’s long-term commitment to structural inclusion.13 Without strong regulatory direction, sponsors may lack the incentive — or the confidence — to prioritize inclusive design, leaving decisions to individual investigators or IRBs, many of whom may lack the training or tools to implement such changes effectively.
Environmental and Interpersonal Barriers
Even when protocols are not explicitly exclusionary, the environments in which trials are conducted often are. For many trans and non-binary individuals, clinical settings are not neutral spaces but sites of prior trauma. Experiences of misgendering, invasive questioning, denial of care, or even outright hostility in medical environments are well documented and contribute to a pervasive mistrust of the healthcare system.6 When such settings are replicated in clinical research environments — whether in hospitals, academic centers, or private clinics — they deter participation before the consent process can even begin.
Research staff often lack the training needed to interact respectfully and competently with gender-diverse participants. Without appropriate education, staff may default to assumptions about pronouns, bodies, or identities, undermining both participant dignity and study integrity. Something as simple as misusing a participant’s name or pronoun can erode trust and create a hostile environment. Yet these basic competencies are still not widely included in Good Clinical Practice (GCP) training or onboarding procedures for clinical investigators and coordinators.14,15
Additionally, the outreach and recruitment materials used in many trials often fail to reflect the communities they aim to engage. Imagery, language, and messaging frequently assume cisgender identities, further signaling to trans and non-binary individuals that they are not the intended audience. Without culturally competent materials, trials risk reinforcing invisibility and deepening the gap between researchers and potential participants. This disconnect is particularly pronounced in trials that rely on community trust — such as those for HIV, mental health, or chronic illness — where inclusion is both scientifically necessary and socially urgent.14
Taken together, these barriers create a self-perpetuating cycle: trans and non-binary individuals remain underrepresented in clinical research, which limits the data available to inform care, which reinforces their exclusion from evidence-based practice, which in turn further erodes trust and participation. Addressing these challenges requires more than symbolic inclusion — it demands a comprehensive rethinking of how trials are conceptualized, executed, and evaluated.
Redesigning Clinical Trials for Gender Inclusivity
Moving beyond the binary in clinical research requires more than retroactive fixes — it demands proactive redesign. To create trials that are inclusive of trans and non-binary individuals, stakeholders must address every stage of the research process: from data collection and protocol development to recruitment, training, and site implementation. These changes are not merely technical: they reflect a broader commitment to equity, scientific accuracy, and community trust.
Inclusive Data Collection
At the foundation of any trial is the data it collects. Yet most studies continue to rely on outdated or incomplete demographic frameworks that conflate sex and gender, restrict responses to “male” or “female,” or fail to account for transitions in gender identity over time. A first step toward inclusivity is the disaggregation of sex assigned at birth from current gender identity, allowing researchers to gather both biological and identity-related information without forcing participants to misidentify themselves or choose between accuracy and dignity.16
Best practices now recommend expanding demographic fields to include multiple gender options, such as “transgender woman,” “transgender man,” “non-binary,” and “prefer to self-describe,” as well as space for pronouns and name-in-use. While this may require updating electronic data capture systems and modifying historical practices, doing so ensures more accurate, representative data and improves participant comfort. It also allows for meaningful subgroup analysis, which can reveal differential responses to treatment that might otherwise go unnoticed.17
Equally important is the use of inclusive, affirming language in informed consent documents and recruitment materials. Terms like “biological sex,” “women of childbearing potential,” or “opposite sex” can alienate participants or introduce ambiguity. Instead, trials should adopt clear, respectful terminology, explain why certain questions are being asked, and avoid unnecessarily gendered language. Transparency and precision in language are key to building trust and avoiding harm.
Protocol Design and Recruitment
Inclusive data collection must be matched by inclusive study design. Too often, eligibility criteria are narrowly defined in ways that exclude individuals receiving gender-affirming care. Participants on hormone therapy may be barred due to perceived confounding effects or lack of precedent. However, unless there is a strong and scientifically justified rationale, these exclusions reflect bias more than biological necessity. Including individuals on gender-affirming hormone regimens and analyzing their data accordingly is both feasible and necessary for real-world relevance.10,18
In addition to modifying inclusion and exclusion criteria, sponsors and investigators must consider how recruitment strategies impact gender-diverse populations. Engaging trans-led organizations and advocacy groups can provide insight into community needs, language preferences, and access barriers. These partnerships help ensure that recruitment is not only culturally competent but also reaches populations who may otherwise remain invisible to traditional outreach methods.17
Community-based participatory research (CBPR) models offer one pathway for more inclusive design. These frameworks emphasize co-creation, transparency, and shared ownership between researchers and the communities they study. By involving trans and non-binary stakeholders from the earliest stages of protocol development, CBPR approaches can improve both the quality of data and the ethical integrity of the research.10
Staff Training and Site Readiness
Even the most inclusive protocol will fall short if trial sites are not prepared to implement it with care and competence. Investigators, coordinators, and front-line staff must be trained in gender-affirming practices — from the correct use of pronouns and names, to understanding the medical needs of trans participants, to handling sensitive situations with respect. This training should be standardized, mandatory, and periodically refreshed, not treated as a one-time or optional exercise.1,18
Site protocols must also reflect inclusivity in more tangible ways. Intake forms, ID verification procedures, restroom access, and private exam accommodations should all be designed to affirm participant identity and protect dignity. Documentation should avoid unnecessary gender markers, and verbal communication should align with participants’ stated preferences. These changes may seem minor, but for many trans and non-binary individuals, they signal whether a space is safe, respectful, and accessible.6
Ultimately, inclusivity is not simply a checklist — it is an ongoing commitment. Trial sponsors, investigators, and institutions must continuously adapt their practices to reflect evolving understandings of gender and the needs of the communities they serve. By embedding gender inclusion into every layer of trial design and execution, the clinical research enterprise can begin to repair trust, improve data quality, and expand access to lifesaving innovation.
The Scientific Imperative: Studying Pharmacokinetics and Interactions
Despite the growing visibility of transgender and non-binary individuals in healthcare settings, clinical pharmacology has yet to adequately reflect their presence. Pharmacokinetic and pharmacodynamic studies remain largely centered on cisgender male and female bodies, with little effort to understand how gender-affirming hormone therapy might influence drug behavior in the body. This absence of targeted research is not just a gap in equity — it is, at least as critically, a gap in scientific rigor.
Hormone therapy fundamentally alters key biological systems that affect drug metabolism, absorption, and clearance. Estrogen therapy, for example, has been shown to modulate liver enzyme activity, potentially influencing how drugs are processed and how long they remain active in the body. Androgens can similarly affect renal function and protein binding, altering the pharmacokinetic profile of many medications.1 Yet despite these plausible and clinically relevant effects, most investigational trials do not stratify data by hormone status or systematically analyze the impact of gender-affirming care on therapeutic efficacy or toxicity.
The few studies that have addressed this question suggest significant implications. A growing area of concern is the interaction between pre-exposure prophylaxis (PrEP) for HIV prevention and estradiol therapy in trans women. Some research has suggested that concurrent estrogen use may lower the plasma concentrations of tenofovir and emtricitabine, the drugs used in PrEP regimens, potentially reducing their efficacy.2 This interaction, while not fully understood, highlights the absolutely critical need for trials that are specifically designed to examine drug–hormone interactions in diverse populations — not merely as a post hoc subgroup analysis, but as a core part of study design.
The consequences of failing to investigate these interactions are far-reaching. For drugs with narrow therapeutic indices — such as anticoagulants, antiretrovirals, or psychiatric medications — small shifts in metabolism can lead to under-dosing, adverse effects, or treatment failure. For example, if a trans man on testosterone therapy experiences faster hepatic clearance of an antidepressant, he may require a higher dose than his cisgender counterparts to achieve the same therapeutic effect. Without controlled studies, these clinical decisions are left to guesswork, increasing the risk of harm.19
Furthermore, the absence of pharmacological research in trans populations limits the development of precision medicine approaches. As the field moves toward personalized therapeutics, based on individual biology and risk factors, the continued exclusion of trans and non-binary bodies perpetuates a system that defaults to the cisgender norm. This is not only ethically troubling — it is scientifically obsolete.
Incorporating gender-affirming hormone therapy into pharmacokinetic research is not a niche endeavor. It is essential for ensuring that the safety, efficacy, and dosing recommendations provided by clinical trials apply to the full spectrum of patients seen in real-world clinical practice. Until researchers commit to this level of inclusion, much of what is considered "evidence-based" will remain incomplete.
From Inclusion to Belonging: Ethical and Regulatory Accountability
The imperative to include trans and non-binary individuals in clinical research is not only scientific — it is fundamentally ethical. Biomedical research is governed by core principles, one of which is justice: the fair distribution of the benefits and burdens of research. This principle, enshrined in foundational documents like the Belmont Report, requires that no group be systematically excluded from participation in or benefit from scientific progress. When gender-diverse populations are overlooked, underrepresented, or actively excluded, this principle is violated.
To move from mere inclusion to genuine belonging, researchers must confront the historical and ongoing marginalization of trans and non-binary individuals within healthcare and research systems. Belonging goes beyond demographics — it speaks to whether participants feel safe, seen, and respected throughout the research process. It requires building environments where trans and non-binary individuals are not simply allowed to participate, but are actively welcomed and engaged as partners in the creation of knowledge.20 The failure to ensure such belonging perpetuates not only exclusion but also distrust, which limits the generalizability and uptake of clinical findings across diverse populations.
Ethical accountability must also be matched by regulatory leadership. Regulatory agencies like the FDA and EMA have increasingly emphasized the importance of diversity in clinical trials, but most current frameworks remain focused on race and ethnicity, with minimal attention to gender identity beyond the male/female binary. Existing guidance does not require sponsors to report how gender-diverse participants are identified, stratified, or analyzed — nor does it demand that trials demonstrate inclusive practices unless specifically targeting LGBTQIA+ populations. This lack of direction leaves trans participants effectively invisible within the regulatory review process, and it allows sponsors to comply with the letter of diversity expectations without fulfilling their spirit.
There is now a regulatory opportunity to shift this trajectory. Future guidance should mandate the collection of both sex assigned at birth and gender identity, require justification for exclusion criteria that disproportionately affect trans individuals, and encourage the submission of subgroup analyses for populations receiving gender-affirming care. The absence of regulatory pressure reinforces a research model grounded in outdated binary constructs, failing to evolve alongside scientific and societal understanding of gender.
But regulation alone is insufficient. Real accountability requires systemic change — across funding agencies, institutional review boards, industry sponsors, and academic research centers. Grantmakers and sponsors must prioritize studies that center marginalized populations, not as an afterthought but as a criterion of excellence. Research designs must embed gender inclusivity from the outset, with input from trans stakeholders. Outcome measures must reflect the needs, risks, and experiences of gender-diverse participants—not simply apply cisnormative benchmarks to all bodies. Inclusive research is not just about recruiting different participants into the same flawed frameworks — it is about transforming those frameworks through collaboration, reflexivity, and sustained commitment.
In short, achieving justice in clinical research requires moving from symbolic gestures of inclusion toward structural conditions of belonging. The path forward lies in reimagining research not as a space from which gender-diverse people are reluctantly accommodated, but as one where they are essential contributors to scientific discovery and equitable health outcomes.
Leading by Example: Emerging Models and Case Studies
While the challenges of inclusion in clinical research are significant, they are not insurmountable. Across the healthcare and research landscape, there are promising examples of institutions, sponsors, and advocacy groups actively working to dismantle exclusionary practices and build models of gender-inclusive research. These initiatives offer not only proof of concept but also blueprints for broader systemic change.
One notable leader (at least, until recently) has been the National Institutes of Health (NIH), which has taken concrete steps to promote the collection of Sexual Orientation and Gender Identity (SOGI) data in federally funded studies. By encouraging researchers to collect SOGI variables alongside traditional demographic data, the NIH is laying the groundwork for more granular and accurate representation of gender-diverse populations in clinical research. This initiative not only improves the visibility of trans and non-binary individuals in biomedical data sets but also enables more sophisticated analysis of health disparities and treatment responses.21
Beyond data collection, some clinical trials have begun to integrate trans-inclusive practices into their recruitment and engagement strategies. For instance, several recent studies in oncology, HIV prevention, and mental health have employed gender-inclusive language in recruitment materials, made space for nonbinary identification on intake forms, and engaged community advisory boards comprised of trans and gender-diverse stakeholders. These advisory boards play a critical role in shaping study design, identifying potential harms or barriers, and improving communication with participants. They also help ensure that protocols reflect lived experience, not just theoretical inclusion.22
There is also growing momentum among advocacy organizations and research networks to develop and disseminate best practices for inclusive research. Some of these efforts have involved partnerships between academic researchers and LGBTQIA+ community groups, aimed at co-developing ethical guidelines, participant protections, and training modules for investigators. These initiatives often adopt a community-based participatory research model, emphasizing co-ownership, shared decision-making, and mutual accountability. In doing so, they shift the paradigm of research from extraction to collaboration, offering a more equitable and respectful approach to knowledge production.9
Though still the exception rather than the rule, these examples demonstrate what is possible when inclusion is prioritized as a core value rather than an optional add-on. They also highlight the importance of institutional will: inclusive trials don’t happen by accident — they are the product of intentional planning, investment, and partnership. As more sponsors and regulatory bodies look to improve trial diversity, these early models offer a valuable foundation for broader transformation.
Ultimately, leading by example means more than adopting best practices—it means creating an environment in which inclusion is the default, not the exception. By following the lead of these pioneers, the clinical research community can begin to repair the trust that has long been broken and move toward a future in which every participant — regardless of gender identity — is welcomed, respected, and seen.
The Impact of Executive Order 13999 — And How the Research Community Can Respond
In early 2025, former President Donald Trump signed Executive Order 13999, directing federal agencies to define sex and gender solely as “biologically male or female,” effectively mandating a binary framework for all official use. Although the order does not carry the weight of law for private institutions or independent researchers, it signals a chilling shift in federal policy — one that could undermine efforts to create inclusive research environments and further marginalize transgender and non-binary individuals across scientific, regulatory, and healthcare systems.
This executive order threatens to undo years of incremental progress. Agencies like the NIH had only recently begun to encourage the routine collection of SOGI data, while regulatory bodies such as the FDA were under increasing pressure to require more inclusive demographic reporting. The order introduces uncertainty into these initiatives. Without explicit legal protections, federal grantees and contract research organizations (CROs) may fear political backlash or funding jeopardy if they attempt to include trans and non-binary participants in a visible way. Ethics committees may feel constrained, and institutional leadership may opt for risk-averse policies that default to the binary.
The long-term impact on clinical research could be significant: reduced inclusion, distorted data sets, and further erosion of trust among marginalized populations. It also emboldens already-present cultural and institutional biases that have historically excluded gender-diverse participants from the clinical trial enterprise.
And yet, the research community is not powerless. Most academic and private sector research is governed by ethical principles that transcend political mandates — including the foundational principle of justice, which demands equitable representation and benefit. Institutional Review Boards, funders, and sponsors can and should continue to require inclusive practices. Universities and independent institutions can reaffirm their commitments to inclusive data collection, gender-affirming policies, and participant protections. International collaborations and industry stakeholders — who are not bound by U.S. federal policy — can take the lead in maintaining gender-diverse representation in global trials.
This moment calls not for retreat, but for renewed resolve. Scientific integrity depends on recognizing and responding to the full spectrum of human diversity. The clinical research field must continue to move forward — even as some systems attempt to drag it backward.
A Future Beyond the Binary
The persistent exclusion of trans and non-binary individuals from clinical research is not only an equity issue — it is a scientific one. When trials overlook or oversimplify gender, they compromise the very rigor they aim to uphold. A research system that fails to account for the diversity of the populations it serves cannot generate evidence that is fully accurate, generalizable, or just. Scientific integrity and social responsibility are not in conflict — they are deeply aligned.
Inclusion must no longer be treated as a niche concern or a matter of political correctness. It is a requirement for ethical and effective research. The call to action is clear: sponsors must reexamine their protocols with inclusion in mind, CROs must build gender competency into their systems and staff training, regulators must issue clearer guidance and enforce expectations that go beyond superficial metrics, and academic institutions must embed inclusive frameworks into study design, mentorship, and funding priorities.
This shift is not merely about increasing participation — it is about transforming how research understands and responds to the complexity of human experience. Moving beyond the binary means recognizing that health outcomes are shaped not only by biology but also by social context, lived experience, and structural inequality. It means acknowledging that gender-diverse individuals have long been treated as outliers in a system designed for others and deciding, as a research community, that this is no longer acceptable.
Creating truly inclusive clinical trials will require effort, humility, and sustained commitment. But the reward is substantial: a body of evidence that reflects the real world, a research culture grounded in respect, and a future in which no one is invisible in the data that shapes their care.
References
1. Walker, Lauren E, et al. “Incorporating transgender and nonbinary participants in phase 1 clinical drug trials: Current knowledge gaps and considerations.” British Journal of Clinical Pharmacology. 90: 2343–2348 (2024).
2. Yager, Jenna, et al. “Gender-Affirming Hormone Pharmacokinetics Among Adolescent and Young Adult Transgender Persons Receiving Daily Emtricitabine/Tenofovir Disoproxil Fumarate.” AIDS Res. Hum. Retroviruses. 38: 939–943 (2022).
3. Schonrock, Zachary, et al. “Transgender people in clinical trials of drugs and biologics: An analysis of ClinicalTrials.gov from 2007 to 2023.” British Journal of Clinical Pharmacology. 90: 2332–2342 (2024).
4. Deutsch, Madeline B, Asa Radix, and Sari Reisner. “What's in a Guideline? Developing Collaborative and Sound Research Designs to Substantiate Best Practice.” AMA J. Ethics. 18: 1098–1106 (2016).
5. Farthing, Alex and John Burkhardt. “Moving Beyond the Binary: How Language and Common Research Practices Can Make Emergency Medicine Less Welcoming for Some Learners and Physicians.” West. J. Emerg. Med. 23: 890–892 (2022).
6. Meda, Karuna and Carly Williams. “Shedding Light on the Experiences Transgender and Non-Binary Patients Face in the Doctor’s Office.” Thomas Jefferson University. 7 Dec. 2022.
7. Sinnard, Morgan T, Stephanie L Budge, and H Kinton Rossman. “Nonbinary individuals’ emotional experiences: Implications for advancing counseling psychology beyond the binary.” Counselling Psychology Quarterly. 35: 19–42 (2021).
8. “Study Reveals Significant Barriers for TGNC Adults Accessing Healthcare in the U.S.” Johns Hopkins Bloomberg School of Public Health. 5 Aug. 2024.
9. McCann, Edward, Gráinne Donohue, and Michael Brown. “Experiences and Perceptions of Trans and Gender Non-Binary People Regarding Their Psychosocial Support Needs: A Systematic Review of the Qualitative Research Evidence.” Int. J. Environ. Res. Public Health. 18: 3403 (2021).
10. Lunde, Claire, et al. “Beyond the Binary: Sexual and Reproductive Health Considerations for Transgender and Gender Expansive Adolescents.” Front. Reprod. Health. 5 Oct. 2021.
11. Castañeda, Reynald. “Overcoming obstacles in trans and nonbinary participation in clinical trials.” Clinical Trials Arena. 29 Jun. 2022.
12. Waddick, Karissa. “Transgender patients are rarely included in clinical trials. Can pharma fix it?” PharmaVoice. 29 Jun. 2023.
13. Grossi, Giuliana. “FDA Quietly Removes Draft Guidance on Diversity in Clinical Trials Following Executive Order on DEI.” AJMC. 31 Jan. 2025.
14. “The Importance of Transgender and Non-Binary Inclusion in Clinical Research.” Center For Info & Study on Clinical Research Participation. 3 Aug. 2023.
15. Rapier, Del and Laura Edwards-Leeper. “Beyond the Binary: A More Inclusive Account of Trans Populations.” NASPA. 17 Apr. 2017.
16. Round, Rosamund, et al. "Improving access for and experience of transgender and non-binary patients in clinical research: Insights from a transgender patient focus group and targeted literature reviews.” Contemporary Clinical Trials. 131: 107243 (2023).
17. Harding, Rie. “Moving Beyond the Gender Binary: A Critical Analysis and Review of Contemporary Scholarship on Nonbinary Gender Identities.” Thesis submitted to the Graduate School of the University of Massachusetts Amherst. May 2023.
18. Alpert, Ash B, et al. “Addressing Barriers to Clinical Trial Participation for Transgender People.” J. Clin. Oncol. 41: 1825–1829 (2022).
19. Versavel, Stacey, et al. “Diversity, Equity, and Inclusion in Clinical Trials: A Practical Guide.” Contemp. Clin. Trials. 126: 107092 (2023).
20. Megibow, Ebonie. “Beyond Binary: Expanding LGBTQ+ Clinical Data.” AAMC Center for Health Justice. 21 Jun. 2023.
21. Nolan, Caitlin J, Troy A Roepke, and Melissa L Perrault. “Beyond the Binary: Gender Inclusivity in Schizophrenia Research.” Biological Psychiatry. 94: 543–549 (2023).
22. Martinez, Enrique O, et al. “Transgender and Non-binary Persons in Contemporary Oncology Randomized Clinical Trials.” Annals of Surgical Oncology. 29: 7958–7960 (2022).