Strengthening the use of real world evidence for drugs

From Health Canada

This project aims to improve our ability to assess and monitor the safety, efficacy and effectiveness of drugs across the drug life cycle. It will do this by optimizing the use of real world evidence (RWE) through stakeholder engagement.

• RWE is evidence about the use and potential benefits or risks of a medical product. This evidence comes from analysis of real world data relating to patient status and/or the delivery of health care routinely collected from a variety of sources.

We expect the outcomes of this project to include:

• increased use of RWE to enhance regulatory decision-making and risk communications throughout the drug life cycle
• improved use and sharing of RWE with our health care system partners
• increased clarity for stakeholders on where and how RWE can be used to support regulatory decision making
• improved access to drugs through the use of new sources of evidence to support approval of drug applications

The tasks for this project include:

• identifying opportunities for enhanced use of RWE throughout the drug life cycle
• mapping potential RWE sources
• developing and implementing a RWE strategy and implementation plan for the use of RWE in regulatory decision making for drugs
• consulting with stakeholders on the RWE strategy

We expect that work on all parts of the project will be complete by fall 2022.