Should Patient Preferences Shape How New Drugs Are Developed?

Official title: Release of draft (step 2) ICH E22: General Considerations for Patient Preference Studies

Open Regulations & Permits Health & Safety
Health Canada wants feedback on international guidelines for using patient preferences in drug development. The idea? When pharmaceutical companies design clinical trials and seek approval for new drugs, they'd systematically consider what matters most to patients—like whether they'd accept more side effects for a faster-acting treatment. This is part of a global effort to standardize how patient input shapes drug development worldwide.

Why This Matters

Ever felt like drug companies don't ask what actually matters to you as a patient? This guideline could change that. If you've ever weighed the trade-offs of a medication—more effectiveness versus more side effects—this is about making sure those preferences count in how drugs get developed and approved.

What Could Change

Drug companies worldwide may need to conduct formal patient preference studies before seeking approval. Regulators like Health Canada could require evidence that patient priorities were considered in clinical trial design. This creates a standardized global framework—so a preference study done in Canada would be accepted by regulators in Europe, Japan, and the US.

Key Issues

  • How should patient preference studies be designed and conducted?
  • When in the drug development process should patient preferences be gathered?
  • How should regulators use patient preference information in approval decisions?

How to Participate

  1. Download the ICH template for public consultations to format your comments properly.
  2. Submit your comments to ich@hc-sc.gc.ca by the deadline. Health Canada will forward all comments to the ICH.

Submit Your Input

Draft Email