Health Canada: Applying the Sex- and Gender-Based Analysis Plus Framework to Clinical Trials

Overview

Health Canada is committed to the Sex- and Gender-Based Analysis Plus (SGBA+) framework to understand the impact of interventions and other initiatives on different groups in Canada. SGBA+ recognizes the importance of considering not only biological sex but also the broader spectrum of gender identities and diverse intersecting factors, such as age, ethnicity, and socioeconomic status. By integrating SGBA+ into policy, research, and program development, Health Canada aims to better understand and address the unique health needs and experiences of different populations. This framework helps to uncover disparities in health outcomes, improve the effectiveness of interventions, and promote equitable health outcomes. The Federal Government’s endorsement of SGBA+ throughout its agencies signals a commitment to fostering a healthcare system that is responsive to the diverse realities of individuals and communities, and ultimately contributing to more inclusive and effective health policies and programs nationwide. 

Health Canada’s Most Recent Draft Guidance

In December 2022, Health Canada released draft guidance on requirements for disaggregated data in new drug submissions. Disaggregated data is data that is broken down by age, sex, race/ethnicity, and other factors relevant to a specific pharmaceutical product (e.g., comorbidities). Health Canada will use disaggregated data to: 

• Assess drug product efficacy and safety in diverse subgroups 

• Ensure consistency with overall results, where feasible 

• Identify areas for focused post-market monitoring to further verify safety and efficacy in specific populations after products are approved for sale 

The draft guidance indicates that disaggregated data requirements will be rolled-out in a tiered approach. First, the requirement will apply to products that have already been submitted to the US FDA and/or EMA as both regulators require submission of disaggregated data. Health Canada’s prefers data from FDA submission to that from EMA submissions as the former requires disaggregation by sex, age, and race/ethnicity.  

If a sponsor has not yet submitted to the FDA or EMA, Health Canada strongly encourages sponsors to include disaggregated data in their Health Canada submission. Sponsors will have to justify the omission of disaggregated data in their submissions. 

Recommended Best Practice

In addition to the submission requirements, the draft guidance outlines best practices for collection of disaggregated data, grounded in a heterogeneity assessment and then supported by a disaggregated data plan. The heterogeneity assessment will allow sponsors to identify the relevant factors by which data should be disaggregated for their application. The disaggregated data plan should outline details for recruitment and enrollment of relevant subgroups and justify the proposed exclusion criteria in relation to these priority populations.  

Although selection of factors for disaggregation should be informed by the heterogeneity assessment, Health Canada has identified three priority factors:  

• Age 

• Sex 

• Race/ethnicity, reporting Statistics Canada classifications for studies conducted within Canada 

 For further guidance on implementation, the Health Canada guidance directs trial sponsors to recent FDA guidance on enhancing enrollment of representative populations in clinical trials. You can read our overview of that guidance here.

Challenges

This Health Canada draft guidance is an important step towards more representative clinical trial data. In our opinion, however, Health Canada’s guidance is a few steps behind the recent FDA and EMA directives. By requiring reporting of disaggregated data, regulators will be able see the gap between how medications have been tested and how they are likely to be used, but with no mandate for representative data collection, this draft guidance is unlikely to close that that gap.  

Notably, Health Canada’s recently released ‘Best Practices for Disaggregated Data’ recognizes the importance of representative trial data and states that “as a standard practice, the diversity of clinical trial participants should reflect the population that will use the drug”; however, this is not currently required. Further, while representative trial populations are best practice, an abundance of evidence shows that this is not currently standard practice. It is unclear from this guidance how, when or if Health Canada will follow the FDA and EMA and require representative trials.