Guidance on collecting and analyzing disaggregated data in clinical trials: Overview

Background

This guidance will help manufacturers (sponsors) interpret amendments to the Food and Drug Regulations (regulations), introduced through the Agile Licensing Framework. Sponsors are required to submit clinical trial data disaggregated by sex, age, race and ethnicity if they have already submitted this data to the United States Food and Drug Administration (US FDA) or European Medicines Agency (EMA).

It is standard practice to collect disaggregated subgroup data during the development of a drug. For examples, refer to the international standards outlined in:

International Conference on Harmonization (ICH) M4E(R2)

This guidance:

ensures that the provisions in the regulations on disaggregated data are interpreted consistently
sets out Health Canada's expectations
supports our efforts to be transparent

The first part of this guidance document outlines how to comply with regulatory requirements for submitting disaggregated data. The second part, Appendices A to C of this guidance, provides information and best practices for collecting, analyzing and reporting on disaggregated data, where applicable.

Disaggregated data is data obtained by breaking down aggregated datasets into subcategories. These subcategories are based on factors such as sex, age, race, ethnicity, co-morbidities or other patient demographics.

Disaggregating data is an important approach to collecting and analyzing data when developing a drug. Doing so:

allows sponsors and Health Canada to assess how effective and safe a drug product is in different subgroups
ensures there is consistency with the overall results, where feasible
indicates where more focused post-market monitoring may be needed to further verify safety and effectiveness in certain subgroups after a product is approved for sale in Canada

The collection and analysis of disaggregated data is at the core of our sex- and gender-based analysis plus (SGBA Plus) approach.

The Government of Canada uses SGBA Plus to assess how diverse groups of women, men and non-binary people may experience policies, programs and regulatory initiatives.

Health Canada uses SGBA Plus to assess differences in how groups of people (subgroups) may react to a drug in terms of both safety and effectiveness.

The "plus" in SGBA Plus acknowledges that SGBA goes beyond sex and gender differences. It indicates the importance of intersectionality, which refers to the many factors that make us who we are. Examples of these factors include:

sex
age
race
gender
geographic location

Learn more:

Policy objectives

People who participate in a clinical trial should represent the population who will be using the drug. This is important as intrinsic (genetic, physiologic) and extrinsic (cultural, environmental) characteristics, including age, sex, race and ethnicity, can lead to different treatment effects. Some, but not all, intrinsic and extrinsic factors that can impact a person's response to a drug product are known.

Patient populations are also often varied and diverse (heterogeneous). Recruiting a wide range of participants makes it possible to disaggregate and analyze data by subgroups of interest (for example, sex, age, race, co-morbidities and medication use).

By requiring sponsors to submit disaggregated data of clinical trial participants, we can assess and, if needed, address any inconsistent risks and benefits of drug products in diverse subpopulations. It’s important that clinical trials encompass traditionally under-represented populations.

Many drug applications that we receive have some degree of disaggregated data. But the data do not always reflect the patient population who will need to use the drug or are not disaggregated by all population subgroups of interest (for example, by age, sex, gender or race and ethnicity).

The regulatory amendments under the Agile Licensing Framework:

reflect what other jurisdictions are doing and
align with existing legislation and regulations of the US FDA and the EMA

The amendments require sponsors to submit clinical data broken down into population subgroups, if they have already submitted this disaggregated data to the US FDA or the EMA.

This is an important step in the phased approach we are taking to implement additional disaggregated data.

Learn more:

Intrinsic and extrinsic differences are outlined in the following guidelines by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH):

ICH E5: Ethnic factors in the acceptability of foreign data (PDF)
ICH Harmonised tripartite guideline (PDF, 98 KB)
ICH E8: General considerations for clinical studies (PDF, 390 KB)

Policy statement

The amendments to the regulations are intended to:

require disaggregated data and subgroup analyses that can help assess differences in key efficacy and/or safety parameters between clinically relevant, prognostic subgroups
increase transparency by supporting assessment and enhancing reporting on the diversity of clinical trial participants for each drug product

Scope and application

This guidance document is for sponsors who apply to Health Canada for market authorization of a drug product through a:

new drug submission (NDS) or
Level I supplement to a new drug submission (SNDS)

The scope of this guidance document includes drug products for human use. These drugs are regulated by the Health Products and Food Branch in accordance with the Food and Drugs Act and its regulations.

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals 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 must 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 us adequately assess the safety, effectiveness or quality of a therapeutic product. We are 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 Drugs Act and its regulations and other applicable guidance documents.

Definitions

Disaggregated data: Data obtained by breaking down large-scale or aggregated datasets into subcategories, such as sex, age, race and ethnicity, or a combination of these (or other) subcategories.

Disaggregated data plan: A plan designed to support the collection and assessment of disaggregated data by age, sex, racial and ethnic groups and associated covariates. The plan is used to establish whether and how a treatment may affect the benefit-risk profile of specific subgroups.

Ethnicity: This is a broader term than race and 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: 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 how power and resources in society are distributed.

Gender identity is not confined to a binary (girl or woman, boy or man). It exists along a continuum and can change over time.

There is considerable diversity in:

how individuals and groups understand, experience and express gender through the roles they take and the expectations placed on them
a person's relations with others
the complex ways that gender is institutionalized in society

What is gender? What is sex? (Canadian Institutes of Health Research)

Heterogeneity assessment: An evaluation examining whether differences in treatment efficacy or safety are anticipated between subgroups in the study population. This assessment is a key aspect of clinical trial protocol design. It describes the measures taken to establish whether there are or could be clinically important age, sex, racial, or ethnic differences in response to study treatment.

Sex: A set of biological attributes in humans and animals. It is mainly associated with physical and physiological features, such as chromosomes, gene expression, hormone levels and function, and reproductive or sexual anatomy.

Sex is usually categorized as female or male, but there is variation in the biological attributes that comprise sex and how those attributes are expressed.

Sex differs from gender, which refers to the socially constructed roles, behaviours, expressions and identities of girls, women, boys, men and gender-diverse people.

Race: A social construct, race is considered an identity factor because of its impact on how people access and receive care and on federal programs and services. The impacts of racial identity must be measured and assessed along with other identity factors as a determinant of health.

In clinical trials and subgroup analyses, differences in biological or biochemical responses to the study drug are explored. Examples include:

differences in gene frequency or expression, disease or complication susceptibility
epigenetic or environmental impacts that can cause different responses between populations (for example, cortisol levels)

Transparency

Health Canada will continue to communicate up-to-date information about drugs for human use.

For reference:

Drug and Health Product Portal:
- Regulatory decision summaries
- Summary basis of decisions giving the reasons for approving prescription drugs for human use, including review of disaggregated data, where applicable
Clinical information portal
- clinical information, including disaggregated data, filed by sponsors seeking approval of human drugs under Division 8 of the Food and Drug Regulations (FDR)

Information posted does not contain confidential business information.

Contact us

Centre for Policy, Pediatrics and International Collaboration
Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
Email: brdd-cppic_brdd-cppci@hc-sc.gc.ca

Contact the appropriate directorate with questions about filing:

Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
Office of Regulatory Affairs
Health Products and Food Branch
Email: brdd.ora@hc-sc.gc.ca

Pharmaceutical Drugs Directorate (PDD)
Health Products and Food Branch
Email: pharma_drug_enquiries-renseignements_medicaments_pharma@hc-sc.gc.ca

Natural and Non-prescription Health Products Directorate (NNHPD)
Health Products and Food Branch
Email: nnhpd.consultation-dpsnso@hc-sc.gc.ca

Marketed Health Products Directorate (MHPD)
Health Products and Food Branch
Email: mhpd-dpsc@hc-sc.gc.ca

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2026-11-04