Canada Develops RWE Guide Anticipating Increased Submissions

26 Apr 2019

New Canadian guidance is expected to help drug sponsors collect high-quality, real-world data that meets international evidence requirements for approval. It focuses on good practices for protocol development and data collection.

Health Canada Wants To Optimize The Use Of Real-World Evidence • Source: Shutterstock

Health Canada has developed a guidance document to help drug sponsors generate real-world evidence (RWE) that is consistent with the regulatory standard of evidence in place in Canada and internationally.

The guidance document includes an overview of some of the issues that sponsors should address in protocol development, and...