Draft guidance document on the collection and analysis of disaggregated data in clinical trials: Regulatory Requirements

Submitting disaggregated data

Health Canada now requires that new drug submissions (NDS) and Level I supplements to new drug submissions (SNDS) for human drugs include clinical evidence that has been disaggregated.

For information on these requirements, please consult:

• Post-notice of compliance changes: Safety and efficacy document

As a first step, these requirements will apply when sponsors:

• have submitted clinical data disaggregated by sex, age and race/ethnicity
  • based on legislative and/or regulatory requirements for market authorization set out by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA)

We expect sponsors to conduct additional subgroup analyses when relevant (for example, co-morbidities, current and past medication use). This is standard practice in clinical trial design.

Currently:

• FDA requires data disaggregated by sex, race/ethnicity and age
• EMA requires data on sex and age, along with a justification if that data is not available

When both datasets are available, we prefer FDA data for sex, age and race/ ethnicity where possible.

When sponsors have not previously submitted disaggregated data to the FDA and/or EMA, we strongly encourage them to provide disaggregated data to Health Canada, where feasible. You are to provide a justification if your submission does not include this data. The justification should include the rationale for why disaggregated data are not applicable to the current submission, and/or why they have not been included.

In general, clinical trials are not designed to assess efficacy and safety in subgroups with statistical rigour. Nor do they have a sufficient number of participants to facilitate such an assessment. For these reasons, we understand that the results from such analyses are descriptive, exploratory in nature and should be interpreted with caution.