Abstract

Background
As scientists with expertise in sex-, gender-, and equity-related research as well as clinicians including pharmacists and physicians, we urgently call for international advocacy to protect equitable and inclusive research. In early 2025, United States federal decisions dismantled initiatives aimed at integrating diverse perspectives into research and halted funding and communication pertaining to public health and equity-focused topics. These decisions may negatively affect scientific knowledge and public information on sex, gender, and equity, making global collaboration more essential than ever.
Incorporating sex, gender, and equity into health research is essential for building evidence that reflects population diversity. Translating this evidence into application requires collaboration and innovation so health care providers and regulatory agencies can support optimal diagnosis and management of health conditions. Health care professionals, including pharmacists, physicians, nurses, and other disciplines, require comprehensive resources to ensure that selected therapies and medication doses are safe and effective in the patient for whom they are to be given. However, groups such as women, the elderly, children, people with disabilities, Indigenous communities, and Two-Spirit, Lesbian, Gay, Bisexual, Transgender, Queer, and additional identities (2S/LGBTQ+) individuals continue to be excluded or overlooked in health research, leading to limited knowledge about diseases, treatments, and differential health risks across populations.
While Canada is taking steps to address these sex-, gender-, and equity-related gaps, more work is needed to ensure that all groups are included in research and that this inclusion leads to robust and translated evidence and guidance and more equitable health care for all. The generation and application of research from bench to bedside require an inclusive approach to be equitably delivered. The Canadian Institute of Health Research’s Institute of Gender and Health (IGH) has been pivotal in driving forward evidence that accounts for sex-, gender-, and equity-related factors in health research, with a mandate focused on fostering research excellence pertaining to the influence of sex and gender on health. The IGH transcends collection of evidence pertaining to sex and gender and focuses on application of findings to identify and address health-related challenges facing women, men, girls, boys, and gender-diverse individuals. In keeping with this vision for inclusive health research, this commentary describes ongoing gaps related to sex, gender, and equity as well as Canadian initiatives that strive to close these gaps, and it calls upon scientists and health care professionals, such as pharmacists, physicians, and nurses, to continue to generate and apply inclusive research to ensure equitable care for all.
Gaps in health research
Health research and policy initiatives are interrelated, with sex and gender science, sex and gender-based analysis plus (SGBA+), and intersectional approaches central to developing equity-based health care and outcomes. 1 Research focused on a single group but broadly applied across populations may overlook critical factors affecting treatment and health care delivery and outcomes. Efforts to close the sex and gender health gap highlight a key limitation: “women’s health” has often been narrowly defined, focusing primarily on reproductive health conditions, and has regarded women as “small men”, ignoring important biological, hormonal, genetic, and social factors. 2 This oversight, particularly in sex-based therapeutic research across preclinical, clinical, and postmarket stages, results in an overreliance on male models. 3 Consequently, many drugs and medical devices have been withdrawn after posing higher risks to underresearched groups. 4
Although continued postmarket pharmacovigilance improves reporting of safety and tolerability of medications used across wider populations, often beyond those that are found in clinical trials, pharmacists often have limited resources to address questions from colleagues related to important queries such as the effects of medications during pregnancy, during lactation, or in pediatric and elderly patients. Furthermore, much of the evidence does not take into consideration gender-diverse populations or the interaction with gender-affirming care-related therapies with therapeutic agents used for management of other conditions. This paucity of available evidence creates profound limitations in application at the bedside.
However, even when collected, sex/gender-related data are often underanalyzed or not reported in most health research, prompting the need for the Sex and Gender Equity in Research (SAGER) guidelines in research reporting. 5 These guidelines offer recommendations for effective inclusion of information related to sex and gender in reporting research. However, although this guidance has been in circulation for almost a decade, studies continue to lack consistent reporting of sex and gender equity. For example, in human pain research, sex/gender factors are not integrated into current pain theories. A systematic review of publications regarding pain from 2012 to 2021 found that less than 20% of data are disaggregated by sex. 6 These limitations have implications on the provision of pain care as women have higher prevalence, pain severity, and functional impairments associated with chronic pain conditions compared with men.
To highlight the importance of inclusion of a sex/gender lens in research, a review on the management of prescription drugs in Canada highlights the urgent need for mandatory sex disaggregation of data from preclinical and clinical studies due to present lack of availability. 7 This omission of evidence holds back sex and gender science and deprives clinicians and consumers from understanding how specific drugs affect individuals and groups. Further, data collection regarding pregnant, lactating, gender-diverse, pediatric, and elderly populations is currently lacking, often leading to off-label usage. Although improving, adverse event reporting systems are insufficiently robust in Canada, compounding the problem.
Sex, gender, and intersectional factors interact to shape health outcomes. Nonetheless, despite the importance of intersectional sex and gender science, frameworks addressing race, ethnicity, gender, sex, age, disability, and socioeconomic status remain underused. This gap highlights the need for better data collection, quality improvement, and standardized outcome measures. COVID-19 research revealed how social inequalities exacerbated maternal and neonatal outcomes, as pregnant people were excluded from vaccine trials despite having higher risks of morbidity and mortality from the disease. 8 Also, findings from a systematic review and meta-analysis on penicillin allergy delabelling interventions found that included studies involved predominantly white participants and higher income countries, with no consideration of how rashes might appear on darker skin or discussion of portability to resource-limited settings. 9 Furthermore, in a study assessing primary care practitioners’ awareness of breast cancer screening recommendations for transgender and gender-diverse (TGD) patients, only 35% of respondents were aware that such recommendations existed. 10 Awareness was notably higher among those with more TGD-specific education and clinical experience as well as among LGBTQI+ individuals.
These examples underscore the need for inclusive research that incorporates diverse populations and their unique experiences, ensuring equitable and culturally relevant care. Application of intersectional factors in health research can mitigate health disparities, and pharmacists are health care professionals who are optimally positioned to address social determinants of health due to accessibility to both patients and other health care professionals.
Equity-informed health research across Canada
Ongoing initiatives are driving systemic change in health care delivery in an equitable manner across the population by generating comprehensive evidence, guidance for health care providers, and recommendations for knowledge translation.
A framework proposed by authors from the United States integrated the role of pharmacists in addressing the social determinants of health at the patient, practice, and community levels, stressing that success must include all members of a health care team. 11 The framework suggests that pharmacists can address health care access and quality by integrating culturally sensitive patient education, addressing medication affordability and adherence strategies, and strengthening interdisciplinary collaboration, among many other strategies. A focus on community engagement and education was central to this framework. Another initiative is the Equity-Oriented Primary Care Interventions for Marginalized Populations (EQUIP) initiative, led by an interdisciplinary research consortium in Western Canada. It aims to create equity-oriented interventions that health care organizations can implement to enhance both staff practices and organizational policies 12 in various health care settings.
Furthermore, clinical care can be directly affected by sex/gender-sensitive research. An investigation on the effects of adding metformin to insulin treatment for pregnant women with type 2 diabetes, 13 conducted in Canadian and Australian centres, found that although metformin-treated infants had lower birth weights and less adiposity, there were no significant differences in neonatal morbidity and mortality between the metformin and placebo groups. However, women receiving metformin had better blood sugar control, required less insulin, gained less weight, and had fewer caesarean deliveries. This illustrates how research can lead to evidence-based improvements, supporting healthier outcomes and fostering equity in health care.
Sex, gender, and intersectional factors are interrelated, and this mesh of experience produces health. A recent study focused on how policy changes can improve health care for people with substance use disorder (SUD), highlighting barriers to care and higher rates of emergency visits and outpatient service use. 14 These findings underscore the need for equity-informed care to address the compounded effects of marginalization and SUD, guiding postpandemic policy and interventions aimed at reducing health care disparities.
Another study exploring factors that affect the sexual health of migrant populations, of whom approximately 70% identified as women, underscored the complexity of factors that influence sexual health outcomes. 15 The authors described intersectional factors such as culture, gender, religion, and social norms that contributed to communication barriers about sex, safer sex practices, and birth control. A commonly expressed barrier was availability of sexual health information in languages spoken by migrants; therefore, the authors advocate for targeted sexual health awareness campaigns and provision of information in languages spoken by migrants.
Lastly, a study aimed at better understanding factors influencing tuberculosis trends over a 50-year period across 6 Indigenous groups in the United States, Canada, and Greenland. 16 The study highlighted that interventions such as the Bacille Calmette-Guérin (BCG) vaccination, radiographic screening, and treatment for latent tuberculosis were associated with more rapid declines in incidence. Additionally, the study underscored the influence of socioeconomic determinants, such as life expectancy, infant mortality, and housing, on these trends; however, the authors did not describe sex or gender factors for the included population. These efforts can guide the development of public health campaigns designed to increase access to health services and address the inequities faced by marginalized communities across Canada.
While these findings provide valuable insights, they also highlight the need for more precise research to close gaps by expanding focus to include a broader range of equity-deserving groups, conditions, and therapeutic areas.
A call to action
To drive meaningful change in health care, scientists, health care professionals, and policy-makers must urgently address ongoing deficiencies in sex, gender, and equity-informed research limiting the implementation of effective health care for all populations, especially women, 2S/LGBTQ+ individuals, pregnant, lactating, elderly, and pediatric populations. These groups have long been excluded from or not explicitly considered in preclinical research and clinical trials, leaving health care needs unmet and creating serious gaps in treatment safety and effectiveness. Despite growing awareness and ongoing advocacy, research gaps persist, undermining the development of precision medicine and tailored health care.
As health care professionals, scientists, and policy-makers, we must seek out, generate, and share inclusive research that reflects the full diversity of human experiences, ensuring equitable outcomes for everyone. Pharmacists in particular are optimally positioned to address health equity by being accessible health care professionals for both the patient and others in the circle of care. The lack of sex and gender science and the exclusion of equity-deserving groups weaken the foundation of modern medicine and perpetuate inequitable health care. We must advocate for systemic changes, progressive research, policy, and regulation; report adverse events and knowledge gaps; and collaborate across sectors to ensure that vulnerable populations have a voice in their own care. Only through these efforts can we create a health care system that is comprehensive, safe, and just.
Conclusion
This commentary reiterates the critical need for consistently prioritizing sex and gender science that integrates equity and intersectional considerations. Persisting gaps in research that hinder the generalizability of findings across sexes and genders underscore the need for more inclusive and comprehensive studies that account for biological, social, and gendered factors. As Canada strives for greater health equity, it is essential to reiterate the inclusion of sex/gender and equity to ensure that health care, treatments, and interventions are safe and effective for all. ■
Footnotes
Author Contributions:
M.M. conceived, designed, and acted as the project administrator for the manuscript; all authors discussed content, procured resources, and contributed to the final manuscript.
Funding:
This work has not received financial support.
Declaration of Conflicts of Interest:
Mira Maximos has received a Canadian Institutes for Health Research (CIHR) doctoral award, a CIHR IGH Travel Award, and honoraria from the Canadian Pharmacists Association as well as the Canadian Society of Healthcare-Systems Pharmacy; Lorraine Greaves is the appointed chair of Health Canada’s Scientific Advisory Committee on Health Products for Women.
