ASK JEAN: disaggregated data questionnaire for drug submissions

21 October 2022

Clinical Trials BC Chronicle Fall 2022 – by Jean Smart, Regulatory Affairs and Quality Officer, Clinical Trials BC

Question: Is there a new disaggregated data questionnaire document necessary for Clinical Trial Applications?
Answer: Yes, there is a new disaggregated data questionnaire for product submissions related to diversity.
However, it is not required for individual clinical trials.

The new questionnaire document came into effect in October 2022. For an initial two-month period, starting from the implementation of the questions on October 3, 2022, sponsors will be encouraged to provide responses. As of December 1, 2022, sponsors must answer all the questions when submitting their application. Following December 1, if an application is submitted without responses, the submission will be screened out.

Health Canada uses disaggregated data to analyze the safety and efficacy of health products. This data allows Health Canada to analyze the safety and efficacy of health products by subpopulations (examples include women, gender-diverse people, racialized and ethnic subpopulations, and specific age groups), verify that the CT participants reflect the diversity of people that will use the product and provide an indication of what post-marketing diversity surveillance may be necessary.

Lack of diversity in clinical trials can result in situations where the benefits and risks of certain health products are unclear for under-represented populations.

HC will be asking five questions in the product information template that is part of the regulatory enrolment process. The intent is to create a baseline for the percentage of applications that include disaggregated data. This is an important first step in validating that health products have been tested on diverse clinical trial participants. Responses to the five questions will not be used in the official review of the submission.

The questionnaire is the first step in a multi-phase approach to collecting disaggregated data from drug submissions. Other phases will include amending regulations by mid-2023 and working internationally to promote the need for greater diversity when a drug is in development.

For more information please go to: Guide: Disaggregated data questionnaire for drug submissions in Canada –