Introducing CoLab: The Evolution of US-Canada International Collaboration on Drug Safety and Effectiveness

Background: Pharmacoepidemiology studies are increasingly completed in distributed research networks that leverage common data models. Recently, Canada’s Drug and Health Technology Agency (CADTH) launched the Post-Market Drug Evaluation (PMDE) Program to use real-world evidence to support key health system decisions on drug safety and effectiveness, forming a new research network called CoLab. CoLab functions similarly to the U.S. Food and Drug Administration's (FDA) Sentinel Initiative. With underlying populations that are largely similar, Canadian and US data have complementary strengths, making a large joint distributed data network mutually beneficial, especially when government agencies in both jurisdictions have similar questions about the safety and effectiveness profile of marketed medications. The FDA Sentinel and CADTH CoLab are partnering to share methodologies and best practices. For example, CADTH’s CoLab network includes the Canadian Network for Observational Drug Effect Studies (CNODES) who maintain their data in the Sentinel Common Data Model to enable international collaborations with the FDA Sentinel.

Objectives: The symposium aims to discuss the advantages and challenges of routine international collaborations in pharmacoepidemiology.

Description: Tarry Ahuja of CADTH describes how the PMDE program fills a key gap in Canada’s drug safety and effectiveness landscape. He outlines how fostering international partnerships can help streamline improved post-market evaluation in light of the increasingly agile regulatory review system and pace of accelerated clinical development. (20 min)
Melissa Kampman of Health Canada describes the needs of Canada’s regulatory agency, particularly with respect to where international collaborations may add significant value, and where historical collaborations have been successful in leveraging collaborative distributed networks. Given Canada’s relatively small population, low prevalence exposures and rare adverse events are challenging even with a sophisticated data infrastructure. (20 min)
David Moeny of the U.S. FDA describes its experience in international collaborations such as the study on thromboembolic outcomes following COVID diagnosis and nitrosamine contamination of angiotensin receptor blockers, highlighting the relative strengths and limitations of the data systems. (20 min)
Judy Maro of the Sentinel Operations Center describes the mechanics of international collaboration among CNODES and Sentinel, including data quality assurance practices, shared epidemiologic expertise, and use of jurisdiction-specific coordinating centers to manage results. (20 min)
Kristian Filion of CNODES will serve as the moderator and lead a panel discussion. (10 min)