Draft guidance document for clinical trial sponsors: SGBA plus demographics action plan in clinical trial applications

Date published: December 19, 2025

On this page

• Introduction
• Regulatory context
• Best practices in clinical trials
• Appendices

1. Introduction

1.1 Overview

This guidance document, outlines Health Canada's expectations for sponsors of clinical trials involving drugs, and provides direction on voluntary the submission of a Sex- and Gender-Based Analysis Plus (SGBA Plus) Demographics Action Plan (DAP), where applicable.

The SGBA Plus DAP is intended to support inclusive clinical trial practices and ensure that sex, gender, and intersecting demographic factors are appropriately considered throughout the trial lifecycle. Submission of a DAP is not a regulatory requirement but is strongly encouraged, to support inclusive trial design.
The recommendations described in this guidance are non-binding and provided for guidance purposes only, and do not create new legal requirements under the proposed Clinical Trials Regulations.

1.2 Scope and application

This guidance document is intended for sponsors conducting, or planning to conduct, clinical trials involving the use of drugs (pharmaceuticals, biologics, or radiopharmaceuticals).

In the Food and Drugs Act (FDA) a clinical trial is defined as a study, involving human subjects, for the purpose of discovering or verifying the effects of a drug, device, or food for a special dietary purpose. 

This guidance document outlines key considerations for the following phases of clinical trials:

• Pivotal Phase III clinical trials involving the use of drugs that are not authorized for sale in Canada
• Clinical trials involving authorized (marketed) drugs used outside of their approved conditions under the Marketing Authorization—Drug Identification Number (DIN) or Notice of Compliance (NOC)—where the trial is designed to provide a basis for marketing approval of a new condition of use (that is, a pivotal study)

This guidance document does not apply to the following:

• Clinical trials involving authorized drugs used within the conditions set out under their NOC or DIN (that is Phase IV clinical trials)
• Comparative bioavailability studies

These considerations represent encouraged approaches and suggested best practices; they do not create new regulatory requirements. Health Canada encourages the adoption of inclusive best practices in all clinical trials where applicable, as they are essential to both scientific validity and ethical responsibility. Ensuring representation of participants from various racial, ethnic, sex, gender, age and socioeconomic backgrounds and more can enhance generalizability of trial results and provide insights into real-world drug effectiveness.^{Footnote 1}

1.3 Policy objectives

This document is intended to assist sponsors seeking authorization to conduct clinical trials in Canada by outlining recommended expectations related to adequate representation of trial participants. It aims to promote inclusive research practices and support equitable drug development across diverse populations in Canada.

Specifically, this document:

• clarifies the submission process and content recommendations for a Sex- and Gender-Based Analysis Plus (SGBA Plus) Demographics Action Plan (DAP)
• provides suggested best practice recommendations for the design and implementation of inclusive clinical trials

This guidance also reflects Health Canada's commitment to SGBA Plus - an analytical and intersectional framework adopted across the Government of Canada's Health Portfolio.

SGBA Plus is used to assess how different factors (such as sex, age, gender, race, ethnicity, indigeneity, disability, and more) affect how Canadians experience federal health initiatives. It helps Health Canada formulate responsive and inclusive health research, surveillance, legislation, policies, regulations, programs and services by considering factors that contribute to differences in accessing health-related resources and health outcomes.

In addition, this guidance document supports Health Canada's SGBA Plus Action Plan which aims to strengthen the systematic integration of sex, gender and diversity considerations throughout Health Canada's work to advance equity, diversity and inclusion.

1.4 Policy statements

The purpose of this Guidance is to:

• promote proactive and thoughtful selection of clinical trial participants, taking into account the stage of drug development, trial objectives, and the epidemiological characteristics of the condition under investigation
• encourage inclusive practices in clinical trial design and recruitment to reflect population diversity and support equitable access
• facilitate robust evaluation of drug safety and efficacy within subpopulation groups, where feasible, to enhance understanding of therapeutic outcomes and disease patterns

1.5 Background

Limited diversity in clinical trial participation can compromise the breadth, relevance and applicability of biomedical research findings.^{Footnote 2} Historically marginalized populations—including women, older adults, racialized and ethnically diverse groups, individuals identifying beyond the binary gender spectrum, and persons with disabilities—are frequently underrepresented across various therapeutic domains.^{Footnote 2}

This underrepresentation can result in constrained datasets, diminished confidence from excluded communities, and underpowered subgroup analyses.^{Footnote 3} Consequently, prescribing practices may fail to account for population-specific safety and efficacy signals, thereby exacerbating health inequities and limiting the benefits of evidence-based interventions.^{Footnote 2}

A review of trials registered in ClinicalTrials.gov from 2000-2020 found that 80 percent of participants identified as White.^{Footnote 4} This underscores the need for recruitment strategies that reflect disease burden across ethnicities and other relevant demographic variables—so that that representation aligns with incidence, prevalence, and outcomes of target conditions.^{Footnote 3}

While average treatment effects may suffice to gauge general estimations of drug effectiveness, failure to include diverse populations can obscure critical safety signals.^{Footnote 3}

In some cases, these safety concerns have emerged decades after approval, demonstrating the real-world implications of trial homogeneity. Table 1 highlights several examples where delayed identification of safety concerns had specific implications for ethnically diverse populations:

(Source:^{Footnote 3} Anand SS et al., BMJ 2025; 388:e082485. doi:10.1136/bmj-2024-082485)

Inclusion of demographically diverse trial participants enables more robust subgroup analyses and facilitates more comprehensive assessments of safety and therapeutic effectiveness. It also deepens insight into how symptoms and treatment results differ among groups, supports more equitable prescribing practices, and enhances public trust in the regulatory system.

To support more inclusive and patient-centered research, sponsors are encouraged to thoughtfully consider demographic and identity-related factors relevant to the intended population for their investigational product. Such an approach fosters greater transparency, promotes informed decision-making, and contributes to improved outcomes while helping to advance equity in healthcare.

2. Regulatory context

2.1 The clinical trials regulations

As part of the regulatory requirements set out in the proposed Clinical Trials Regulations, pursuant to section 11(2)(e), sponsors must submit a protocol as part of the application to enable the Minister to determine whether authorization should be granted. Section 1(1) defines the protocol as a document describing the objectives, design, methodology, study population, statistical considerations, and organization of a clinical trial.

In alignment with these provisions, section 46(1)(b) requires that a clinical trial be conducted in accordance with Good Clinical Practices (GCP), including by ensuring that the study population of the clinical trial be consistent with the objectives of the trial.

Building on this regulatory foundation,and Health Canada's commitment to evidence-based decision-making, sponsors are encouraged to submit a Sex- and Gender-Based Analysis Plus (SGBA Plus) Demographics Action Plan as part of all applicable regulatory submissions. This recommendation while not regulatory requirement, underscores the importance of designing and conducting clinical trials with a comprehensive understanding of the diverse characteristics of the population for whom the health product is intended.

This recommendation supports a methodical and inclusive approach to trial participant recruitment, which takes into account the stage of drug development, the specific objectives of the clinical study, and the underlying epidemiology of the disease or condition under investigation. By doing so, sponsors ensure that the data generated are reflective of real-world use and can be generalized to the broader target population.

Health Canada encourages the integration of SGBA Plus principles throughout the clinical development process. This includes the systematic consideration of intersecting demographic factors such as sex, gender identity, race, ethnicity, age, disability, and more and other relevant determinants of health. These variables have the potential to influence pharmacokinetics, pharmacodynamics, clinical outcomes, and patient safety profiles, and must therefore be thoughtfully integrated into study design, participant eligibility criteria, and analytical plans.

Incorporating SGBA Plus demographic considerations contributes to the generation of high-quality, reliable data that are representative and equitable, ultimately supporting improved health outcomes across diverse population groups.

2.2 Submitting a SGBA plus demographics action plan

Submission of a SGBA Plus Demographics Action Plan (DAP) is optional. When provided, it should be in accordance with Health Canada's standard procedures for electronically filing regulatory submissions in either Electronic Common Technical Document (eCTD) format or non-eCTD format.

Sponsors should refer to the following guidance documents, as applicable:

• Guidance document: preparation of regulatory activities in the Electronic Common Technical Document (eCTD) format
• Guidance document: Preparation of regulatory activities in non-eCTD format
• Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications

The SGBA Plus DAP may be submitted within Module 1.7.1 Study Protocol. Sponsors can choose to submit the plan either as an embedded section within the clinical trial protocol or as a standalone document. Sponsors are encouraged to clearly state in the cover letter accompanying the submission whether a SGBA Plus DAP is included, and identify its exact location within the application to facilitate review.

It is anticipated that information pertaining to the SGBA Plus DAP will overlap and be reflected in multiple other sections of Module 1, where contextually appropriate.

Examples of relevant subsections include:

• Module 1.4.1. Protocol Safety and Efficacy Assessment Template (PSEAT)
• Module 1.7.1. Protocol
• Module 1.7.2. Informed Consent Forms (ICF)

SGBA Plus demographic information overlapping within these sections—such as epidemiological data, clinical population characteristics, and disease pathophysiology literature—contributes to a more cohesive and transparent presentation of demographic inclusivity within the proposed clinical trial framework.

Submission of Comparative Inclusion Plans in Support of SGBA Plus DAPs

Health Canada will also consider other equivalent inclusive strategies or recruitment plans—such as Diversity Action Plans or Inclusive Clinical Trial Recruitment Strategies— that have been previously submitted to other regulatory authorities, provided they sufficiently address expectations in this guidance.

Sponsors are encouraged to reference such submissions within the cover letter and include the relevant documentation in Module 1.7.1 Study Protocol, either appended to the clinical trial protocol or presented as a separate, stand-alone document.

2.3 Omission of a SGBA plus demographics action plan

Health Canada strongly encourages Sponsors to provide a SGBA Plus Demographics Action Plan whenever feasible. In circumstances where submission of such a plan is not applicable, sponsors are encouraged to provide a clear explanation of the extent to which the following apply:

• Epidemiological considerations: The prevalence or incidence of the disease or condition for which the investigational drug is being proposed is being assessed (including characteristics of the patient population likely to use the drug).
• Feasibility constraints: Implementation of a SGBA Plus Demographics Action Plan is not feasible or would be impracticable—such as in the context of a public health emergency requiring urgent intervention.
• Population homogeneity: The disease or condition under investigation is relatively homogeneous with respect to race, ethnicity, sex, age, and more
• Rare disease challenges: The condition being studied is rare and presents unique challenges in participant recruitment (for example, it predominantly affects a single demographic group, making proportional recruitment of other groups unrealistic).

Any explanation provided may be supported by relevant data and evidence. Sponsors are encouraged to clearly articulate the rationale underlying their proposed enrollment targets.

This justification may be submitted either as a stand-alone document or as a dedicated paragraph within the clinical trial protocol. within Module 1.7.1 of Module 1.

2.4 Content of a SGBA plus demographics action plan

The SGBA Plus Demographics Action Plan is intended to ensure that clinical trial recruitment strategies appropriately reflect the demographic diversity of the Canadian population affected by the disease or condition under investigation. To support this objective, Sponsors are strongly encouraged to adopt the following structured format:

i. Overview and epidemiology of the disease

• Provide a comprehensive summary of the disease or condition, including relevant pathophysiological mechanisms and clinical features as applicable to the proposed clinical trial.
• Present existing epidemiological data that describe the distribution of the disease or condition across various population groups. Emphasize incidence and prevalence rates and stratify by relevant demographic characteristics (for example, sex, gender, age, racial and ethnic backgrounds, geographic regions and more).
• Where applicable, discuss known differences in the use or effectiveness of current prevention, screening, diagnostic, or treatment modalities across diverse population subgroups.

ii. Intended clinical trial population

• Clearly define the intended population for the clinical trial to ensure that study findings are scientifically robust, ethically appropriate, and reflective of real-world clinical application.
• Outline the characteristics of the proposed study population, detailing eligibility requirements and inclusion/exclusion criteria.
• Account for the intersectionality of various characteristics that influence health outcomes, therapeutic responses, and access to care. Consider key demographic, epidemiological, and clinical variables, as well as SGBA Plus factors.

Examples of commonly considered SGBA Plus demographic variables include:

• sex (biological attributes)
• gender (social constructs related to roles and identities)

Plus: Other intersecting identity factors such as (this is not an exhaustive list):

• race
• ethnicity
• indigeneity
• age
• disability
• language
• socioeconomic status
• geographic location
• sexual orientation

iii. Currently known differential effects and sensitivities

Sponsors may provide available evidence that highlights any known similarities or differences in disease manifestation or treatment response across distinct population groups—both globally and within Canada. Specifically:

• present current understanding of demographic patterns relevant to the disease or condition, supported by incidence and prevalence data across various subgroups
• identify and describe any observable health disparities, such as increased disease burden among lower-income populations or heightened susceptibility linked to specific demographic variables
• where applicable, summarize any differential outcomes observed in clinical pharmacology studies, including pharmacokinetic/pharmacodynamic data or pharmacogenomic findings associated with particular racial, ethnic, or other population subgroups
• utilize and reference pooled data sources or publicly available demographic datasets where applicable to enrich the analysis
• where patterns suggest meaningful subgroup differences, sponsors are encouraged to consider increased enrollment of these populations in order to obtain meaningful trend analyses and identification of potential differences

iv. Barriers to recruitment and proposed mitigation strategies

To support inclusive participation in clinical trials, sponsors are encouraged to identify anticipated barriers to recruitment of underrepresented populations and propose actionable solutions. These may include:

• defining specific enrollment targets for underrepresented populations, based on disease epidemiology and relevant preclinical or historical data suggesting subgroup-specific impacts
• outlining operational strategies to enhance recruitment among traditionally marginalized populations, including culturally sensitive outreach efforts and accessible trial communications. Describe retention initiatives, which may include (but are not limited to):
  • site accessibility and support (for example, translation, transportation options, accommodations for individuals with disabilities and more)
  • community engagement plans (for example, collaboration with local healthcare providers, advisory boards, and patient advocacy organizations)
  • trial design adaptations to reduce participation barriers (for example, telemedicine options, use of local laboratories and more)

Sponsors are encouraged to present these strategies transparently and to monitor the effectiveness of such measures throughout the trial lifecycle.

Refer to Section 3, for overarching recommendations and guidance on developing inclusive clinical trials and strategies for overcoming common recruitment challenges.

3. Best practices in clinical trials

3.1 Best practices for developing inclusive clinical trials

While not a regulatory requirement, these recommendations are intended to support sponsors in strengthening trial design and promoting equitable participation across diverse populations.

1. Integrating equity, diversity, and inclusion (EDI) throughout trial design

• Apply Sex and Gender-Based Analysis Plus (SGBA Plus) and intersectional frameworks to ensure trial populations accurately reflect the diversity of those affected by the condition.
• Proactively include historically underrepresented groups, such as racialized communities, Indigenous Peoples, women, older adults, LGBTQ2S+ individuals, and persons with disabilities.
• Embed culturally safe and anti-racist principles across all phases of the trial ^{Footnote 5Footnote 6}
• Develop culturally sensitive protocols through meaningful consultation with relevant community leaders and patient advocates.
  • For example, avoid pan-indigenous approaches and thoughtfully consider distinctions among First Nations, Inuit, and Métis peoples ^{Footnote 7}

2. Engage early and authentically with communities

• Establish partnerships with community leaders, patient advocates, and local organizations to collaboratively design recruitment strategies and informational materials.
• Cultivate long-term, sustainable relationships with communities, moving beyond one-time or transactional outreach.
• Use community-based participatory research (CBPR) methodologies to enhance trust and ensure cultural relevance^{Footnote 5}
  • For instance, initiate early relationship-building efforts with Indigenous representatives (First Nations, Inuit, and Métis) prioritizing trust, open communication, and mutual respect^{Footnote 7}
  • Engagement should be defined by community members themselves, not solely by researchers^{Footnote 8}

3. Improve trial access and participation

• Implement decentralized or hybrid trial models (for example, e-consent, remote data collection, and virtual consultations) to reduce travel and time burdens on participants^{Footnote 5}
• Provide supportive services such as transportation, child care, and interpretation services, to facilitate participation and improve accessibility
• Establish clinical trial sites in geographically diverse areas, including rural and community-based locations, to reach underserved populations^{Footnote 5}
  • For Indigenous communities (First Nations, Inuit, and Métis), consider mobile clinics in collaboration with local Indigenous organizations to foster culturally safe engagement and reduce travel barriers^{Footnote 8}

4. Collect and report participant data transparently

• Consult with underrepresented populations and adhere to recommended data governance principles to ensure collection, dissemination and publication of data are done appropriately.^{Footnote 5}
  • For example, the First Nations principles of ownership, control, access and possession – commonly known as OCAP – assert that First Nations have control over data collection processes, and that they own and control how such information can be used^{Footnote 9}
• Ensure demographic data is self reported, with inclusive options that allow for free text identification.
• Avoid using "other" as a catch-all category; instead, allow participants to define their identity^{Footnote 5}
• Clearly communicate the purpose and relevance of collection, analysis and reporting of demographic data so as to address any privacy or confidentiality concerns with participants.^{Footnote 5}
• Implement necessary safeguards to protect participant identity and privacy.^{Footnote 5}

5. Diversify staffing and train teams in inclusive methods

• Recruit team members from diverse backgrounds to bring lived experience and valuable insight into cultural, social, and systemic health factors. This will help ensure trial design and implementation are responsive to real world barriers and community needs.
• Leverage diversity to strengthen decision making and avoid homogeneity, which may unintentionally lead to overlooking key variables and perpetuate biases.
• Diverse teams are better equipped to identify blind spots and make more equitable, informed decisions.Provide training in equity based approaches to recruitment, consent, data collection and participant engagement to help reduce unintentional bias, enhance cultural competence, support ethical research conduct and strengthen team cohesion and accountability.

3.2 Best practices for overcoming common recruitment barriers in clinical trials

Effective recruitment and retention are essential to generating valid, meaningful and generalizable clinical trial results. However, numerous logistical, communicative and structural barriers often hinder participation.^{Footnote 9} While not exhaustive, the following outlines common challenges and offers practical strategies to improve inclusivity in clinical trials. These strategies are intended for guidance purposes only and are encouraged to support best practices, but they do not constitute regulatory requirements under the Clinical Trials Regulations.

1. Lack of awareness

• Many potential participants are unaware that clinical trials exist or their eligibility.
• Surveys indicate that up to 85% of patients are unaware of clinical trial options at the time of diagnosis.^{Footnote 10}

Strategies for consideration:

• Launch public education campaigns and community outreach initiatives.
• Partner with healthcare providers to increase awareness of ongoing trials.^{Footnote 11}
• Co-develop trial materials with underrepresented groups to ensure messaging is inclusive, accessible and culturally relevant.^{Footnote 5}
• Improve public understanding and health literacy to close the knowledge gap ensuring more individuals are engaged and informed regarding the research process.^{Footnote 6}

2. Mistrust and historical injustices

• Racialized and Indigenous communities may experience deep-rooted mistrust of medical and research institutions due to historical and ongoing injustices, which can deter participation.

Strategies for consideration:

• Build long-term, trust based relationships with communities.
• Engage community leaders and stakeholders throughout the research process (from trial design to implementation (collaborating with individuals or groups/organizations that may be implicated by the study)^{Footnote 12}
• Ensure transparency, cultural safety, and accountability in all interactions.

3. Overly restrictive eligibility criteria

• Narrow inclusion/exclusion criteria can limit trial relevance, equity and generalizability of clinical trial findings.
• Stringent exclusions based on age, comorbidities, prior treatments, pregnancy status disproportionately affect marginalized populations – particularly older adults, women, racialized groups and individuals with disabilities.^{Footnote 13Footnote 14}
• Restrictive eligibility criteria reduce trial participation and limit the ability to assess safety and efficacy across diverse populations.

Strategies for consideration:

• Reassess eligibility criteria to balance scientific rigor with inclusivity
• Consider adaptive or pragmatic trial designs for greater generalizability^{Footnote 15}
• Broaden inclusion criteria and remove unnecessary exclusions to improve access, enhance data quality, and ensure that trial outcomes reflect the populations most affected by the disease^{Footnote 16}
• Thoughtfully consider selection criteria to maximise participation^{Footnote 16}, and broaden overly complex criteria^{Footnote 17}, to increase real-world applicability.

4. Geographic and transportation barriers

• Participants in rural or underserved areas may face challenges accessing trial sites.

Strategies for consideration:

• Implement decentralized or hybrid trial models, offer travel reimbursement, and partner with local clinics to improve accessibility.
• Use remote monitoring technologies and virtual consultation platforms to engage with participants who face travel elated barriers^{Footnote 6}
• Leverage telemedicine to simulate face-to-face interactions, build trust, reduce logistical burdens and improve the overall patient experience.^{Footnote 18}

5. Language and health literacy

• Complex consent forms and medical jargon can discourage participation, especially among non-native speakers or those with low literacy.

Strategies for consideration:

• Use plain language, multilingual materials, and visual aids
• Provide interpreters or cultural mediators.
• Ensure representation of minority ethnic groups within research and healthcare teams to foster trust and understanding^{Footnote 19}. Representation helps patients feel respected and encourages dialogue. Shared cultural or linguistic backgrounds allow team members to explain medical concepts clearly, reduce misunderstandings, and build trust — strengthening language accessibility and health literacy.

6. Time and financial burden

• Frequent visits, long procedures, and unpaid time off work can deter participation.

Strategies for consideration:

• Offer flexible scheduling and compensation for time and expenses.
• Provide support services such as childcare, eldercare and transportation assistance.

7. Underperforming trial sites

• Some sites fail to meet recruitment targets due to limited outreach, poor engagement or small patient pools.

Strategies for consideration:

• Monitor site performance, provide targeted recruitment support.
• Select sites based on demographic alignment and community engagement capacity.

8. Leveraging technology while addressing the digital gap

• The digital gap is a barrier that limits access to technology, internet connectivity, and digital literacy. Exclusive reliance on digital platforms may inadvertently exclude individuals with limited internet access or digital literacy, including older adults, low-income populations, and those in remote communities.
• Technology plays a vital role in streamlining recruitment, particularly through centralized databases that help identify and engage potential participants ^{Footnote 6.}
• Digital tools such as targeted advertising via social media and online platforms can accelerate recruitment and broaden outreach to various audiences, ultimately improving patient enrollment ^{Footnote 6}

Strategies for consideration:

• Combine digital outreach with traditional methods such as phone calls, flyers, and community events. Be mindful of technology access and literacy gaps when designing recruitment strategies. Inclusive recruitment strategies must therefore balance technological innovation with accessible, non-digital outreach methods

Appendices

Appendix A – Glossary

Terms used throughout the policy are defined below, although it is not an exhaustive list.^{Footnote 20} The glossary will be updated as required.

Demographic factors:

Are the statistical characteristics of a population that help describe and analyze groups of people. These factors are commonly used in fields like sociology, marketing, public health, and policy making to understand trends, behaviours and needs. Examples of common demographic factors include age, gender, race and ethnicity, education and more

Disaggregated data:

Refers to information/data that has been broken down into smaller subcategories (that is by gender, race, age, income, geography and more) to reveal patterns or trends that might not be apparent in aggregated data

Diversity:

Consists of the conditions, expressions and experiences of different groups identified by age, culture, ethnicity, education, gender, disability, sexual orientation, migration status, geographic location, language and religious beliefs (and other factors)

Ethnicity:

A broader term than race. The term is used to categorize groups of people according to their cultural expression and identification. Commonalities such as racial, national, tribal, religious, linguistic, or cultural origin may be used to describe someone's ethnicity.

Gender:

Refers to the socially constructed roles, behaviours, expressions and identities of girls, women, boys, men, and gender diverse people. It influences how people perceive themselves and each other, how they act and interact, and the distribution of power and resources in society. Gender has traditionally been conceptualized as a binary (girl/woman and boy/man) yet there is considerable diversity in how individuals and groups understand, experience, and express it.

Health equity:

Refers to the absence of unfair and avoidable or remediable differences in health among population groups defined socially, economically, demographically or geographically

Intersectionality:

An approach to analyzing social relations and structures in a given society which recognizes that every person's identity consists of multiple overlapping factors. The term was first coined in 1989 by scholar and civil rights activist Kimberlé Crenshaw to explain how race interacts with gender and other factors to produce barriers for Black women.

Today, intersectionality is understood more broadly as a framework for understanding how people may experience systemic privilege and oppression based on their intersecting identities, depending on how they are valued by social institutions.

Race:

A social construct and is not grounded in biology: racial categorization schemes were invented by Western scientists to support worldviews that considered some groups of people as superior and some as inferior. This is a concern in the health sciences, because beliefs about race-based biological differences can influence how health care providers perceive their patients and make diagnostic or treatment decisions. However, the racialization of certain groups is a very real social phenomenon, and as such, it is necessary to pay attention to race as an identity factor because it has an impact on how people access and receive care and other federal programs and services.

It is recognized that racial categorizations are not biological, the impacts of racial identity need to be measured and assessed along with other identity factors as a determinant of health.

Sex:

Refers to a set of biological attributes in humans and animals. It is primarily associated with physical and physiological features including chromosomes, gene expression, hormone levels and function, and reproductive/sexual anatomy. Sex can be categorized as male, female, or intersex, as there is variation in the biological attributes that comprise sex and how those attributes are expressed.

Sex and gender based analysis plus (SGBA Plus):

An analytical process used in the Health Portfolio. It is an intersectional approach to assess how factors such as sex, gender, age, race, ethnicity, socioeconomic status, disability, sexual orientation, cultural background, migration status, and geographic location interact and intersect with each other and broader systems of power.

Conducting this analysis helps Health Canada to understand how intersecting identity factors, histories, power relations, distribution of resources and individuals' lived realities contribute to differences in accessing health-related resources and health outcomes. Applying SGBA analysis enables the Health Portfolio to formulate responsive and inclusive health research, policies, services, programs and other initiatives to promote greater health equity.

Appendix B – Reference list

• Alarcón Garavito, G. A., Gilchrist, K., Ciurtin, C., Khanna, S., Chambers, P., McNally, N., Merivale, E., Carr, E., Yu, R., & Vindrola-Padros, C. (2025). Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: A systematic review. Trials, 26, Article 65. https://doi.org/10.1186/s13063-025-08769-y
• Anand, S. S., Arbour, L., Ogilvie, G. S., & Tita, A. T. N. (2025). Inclusive research: A path to equity and better outcomes. BMJ, 388, e082486. https://www.bmj.com/content/388/bmj-2024-082486
• Anand, S. S., Bosch, J., Mehran, R., Mehta, S. R., & Patel, M. R. (2025). Designing inclusive clinical trials: How researchers can drive change to improve diversity. BMJ, 388, e082485. https://www.bmj.com/content/388/bmj-2024-082485
• Antidote. (2024). 5 common clinical trial patient recruitment challenges and solutions. https://www.antidote.me/blog/5-common-clinical-trial-patient-recruitment-challenges-and-solutions
• ASH Clinical News. (2021). Overly restrictive clinical trial exclusion criteria hinder participation. https://ashpublications.org/ashclinicalnews/news/1884/Overly-Restrictive-Clinical-Trial-Exclusion
• Canadian Cancer Clinical Trials Network. (2024). EDI Framework for Clinical Trials. https://3ctn.ca/wp-content/uploads/2024/08/EDI-Framework.pdf
• Canadian Cancer Clinical Trials Network. (2024). Improving Trial Access for Indigenous Peoples. https://3ctn.ca/wp-content/uploads/2024/04/Improving-Trial-Access-for-Indigenous-Peoples.pdf
• Canadian Institutes of Health Research. (n.d.). Research Excellence Framework. https://cihr-irsc.gc.ca/e/53947.html
• Clariness. (n.d.). Challenges in patient recruitment for clinical trials. https://clariness.com/resource/challenges-in-patient-recruitment-clinical-trials/
• Clinical Trials Transformation Initiative. (2023). Diversity Recommendations Final. https://ctti-clinicaltrials.org/wp-content/uploads/2023/05/CTTI_Diversity_Recommendations_FINAL.pdf
• Collister, D., Song, C., & Ruzycki, S. M. (2024). Fostering diversity in clinical trials: Need for evidence and implementation to improve representation. BMJ Medicine, 3(1), e000984. https://bmjmedicine.bmj.com/content/3/1/e000984
• First Nations Information Governance Centre. (n.d.). OCAP^®
• Training. https://fnigc.ca/ocap-training/
• Health Canada. (2021). Sex and Gender-Based Analysis Policy. https://www.canada.ca/en/health-canada/corporate/transparency/heath-portfolio-sex-gender-based-analysis-policy.html
• Kim, E. S., et al. (2021). Modernizing clinical trial eligibility criteria: Recommendations of the ASCO-Friends of Cancer Research work group. Clinical Cancer Research, 27(9), 2408–2415. https://aacrjournals.org/clincancerres/article-abstract/27/9/2408/672178/Modernizing-Clinical-Trial-Eligibility-Criteria
• Klompstra, L., Strömberg, A., Jaarsma, T., & Hendriks, J. M. (2025). Challenges and strategies for effective recruitment and retention of participants in clinical research studies. European Journal of Cardiovascular Nursing. Advance online publication. https://doi.org/10.1093/eurjcn/zvae158
• National Institutes of Health. (n.d.). Why awareness of clinical research matters. https://www.nih.gov/health-information/nih-clinical-research-trials-you/need-awareness-clinical-research
• Siegel, C. A., et al. (2024). Broadening eligibility criteria in IBD trials. Journal of Crohn's and Colitis, 18(12), 1967–1972. https://academic.oup.com/ecco-jcc/article/18/12/1967/7697443?login=false
• Solitano, V., Jairath, V., & Danese, S. (2025). Striking the right balance for eligibility criteria for clinical trials in inflammatory bowel disease. United European Gastroenterology Journal. https://onlinelibrary.wiley.com/doi/epdf/10.1002/ueg2.12749
• Turner, B. E., Steinberg, J. R., Weeks, B. T., Rodriguez, F., & Cullen, M. R. (2022). Race/ethnicity reporting and representation in US clinical trials: A cohort study. Lancet Regional Health – Americas, 11, 100252. https://www.sciencedirect.com/science/article/pii/S2667193X22000692
• Yazdani, A., et al. (2024). Assessing patient perspectives on virtual clinical trials. PLOS ONE, 19(6), e0324807. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0324807

Appendix C – Useful resources

Health Canada's SGBA Plus Action Plan

• Sex and Gender Based Analysis Plus in Action at Health Canada 2022-2026

SGBA Plus Resources

• Women and Gender Equality Cananda – What is Gender Based Analysis Plus
• Canadian Institutes of Health Research- Online Training Modules: Integrating Sex and Gender in Health Research
• Canadian Institutes of Health Research – Guidance on the Use of Standards for Race-Based and Indigenous Identity Data Collection and Health Reporting in Canada

Statistics Canada – Visible Minority and Population Group Classifications

The First Nations Principles of OCAP^®

• Understanding OCAP^®

U.S. Food and Drug Administration

• Report to Congress : Diversity Action Plans Summary
• Guidance for Industry: Inclusion of Older Adults in Cancer Clinical Trials

European Medicines Agency

• Clinical Trials Regulations - Disaggregated Data Requirements
• Guideline on the investigation of subgroups in confirmatory clinical trials

Canadian Cancer Clinical Trails Network – Equity, Diversity and Inclusion (EDI) in Clinical Trials

• Equity, Diversity, and Inclusion (EDI) Framework for Clinical Trials
• Improving Trial Access for Indigenous Peoples

World Health Organization

• Guidance for Best Practices for Clinical Trials; Resolution (WHA75.8)

The Good Clinical Trials Collaborative

• Global Community Initiative - Guidance

Appendix D – Heath Canada clinical trial application guidance documents

The following guidance documents may be useful in the preparation of clinical trial applications:

• Guidance for Clinical Trial Sponsors: Clinical Trial Applications
• Guidance for Sponsors of Clinical Trial Applications: Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications
• Quality guidance documents for Biologics (refer to the Relevant Links page for a list of the documents)
• Guidance document: preparation of regulatory activities in the Electronic Common Technical Document (eCTD) format
• Draft guidance document on the collection and analysis of disaggregated data in clinical trials

The tables below outline the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) guideline(s) implemented by Health Canada.

• Health Canada / ICH Guidance Document E6: Good Clinical Practice: Consolidated Guideline (Efficacy, Multidisciplinary, Quality and Safety Guidelines)

Note about guidance documents in general

Guidance documents provide assistance to industry and health care providers on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document should be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help Health Canada adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of the Food and Drug Regulations and other applicable policy and guidance documents.

This document may be updated in the future to align with any future changes made to the Food and Drugs Act or its regulations.