Health Canada to monitor the inclusion of disaggregated data in clinical evidence: Notice to stakeholders
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This notice is to inform stakeholders that Health Canada will be using a questionnaire to verify if disaggregated data for sex, age and race is present in clinical evidence. This will apply to new drug submissions (NDS) and supplements to new drug submissions (SNDS).
It’s standard practice in clinical trials to collect disaggregated data on sex, age and race. However, Health Canada has not had a mechanism to efficiently track, analyze and report the number of submissions that include this key data. In support of Health Canada’s Sex- and Gender-Based Analysis Plus Action Plan, the Health Products and Food Branch is improving capacity to collect the disaggregated data that we need to assess, monitor and report on the diversity within clinical trial populations. This mechanism is the first step in our larger goal of ensuring consistent representation of diverse populations in all clinical trials.
To establish a baseline, beginning in fall 2022, sponsors submitting an NDS or a SNDS that contains clinical data will be asked to answer a series of questions. Your answers will help us determine if your clinical trial data has been disaggregated by sex, age and race.
The questions will be on the product information template for human drugs. This template is part of the regulatory enrolment process for all submissions (NDS and SNDS) that have clinical evidence. The questionnaire will be launched on October 3, 2022. For an initial two-month period, sponsors will be encouraged to complete the questionnaire; as of December 1, 2022, responses will be mandatory. Examples of clinical evidence include:
- new, expansion or change to an indication of use
- changes to safety information, such as:
- adverse reactions
- warnings and precautions
- serious warnings and precautions box
- changes to efficacy information
- changes to dosing information, such as:
- dosage form
- dosage strength
- new route of administration
- change to duration of treatment
- change in recommended dose range if safety and efficacy studies are required to support the proposed change
- results of confirmatory trials (intermediate or final) specified in the letter of undertaking
- submission for the purpose of obtaining data protection extension
- change to the clinical trial section of the product monograph or package insert
For more information, consult the Guide to the new disaggregated data questionnaire for drug submissions.
For questions about whether the questions apply or how to answer them, email the Centre for Policy, Pediatrics, and International Collaboration at email@example.com.
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