Post-Market Drug Evaluation Program and the CoLab Network launched by CADTH

Canada’s Drug and Health Technology Agency launches its Post-Market Drug Evaluation Program and CoLab Network to respond to decision-makers on the safety and efficacy of drugs in use in real-world settings

In September 2022, Canada’s Drug and Health Technology Agency (CADTH) announced the launch of its Post-Market Drug Evaluation (PMDE) Program and the CoLab Network, its underpinning collaboration of expertise. CoLab will leverage Canada’s expert applied researchers, methodologists, and data analysts to help meet the PMDE needs of federal, provincial, and territorial (FPT) decision-makers to fill gaps in information on the safety and effectiveness of drugs used in real-world settings

PMDE focuses on drugs that have proceeded through the approval process and are available to patients and consumers. It ensures the safety and efficacy of drugs by diverse patient populations outside the controlled experimental environment of clinical trials. This need has been amplified by accelerated drug development, streamlined regulatory approval processes, and growing demand for rapid access to new products.

CADTH’s PMDE Program is the rebirthing of the Drug and Safety Effectiveness Network (DSEN), which was established in 2009 by Health Canada and the Canadian Institutes of Health Research (CIHR) to address PMDE. In August 2021 it was announced that stewardship of DSEN would be transferred to CADTH, an independent, not-for-profit agency funded by Canadian FTP governments. In February 2022, CADTH announced its transformation of DSEN into the PMDE Program, an element of CADTH’s 2022–2025 Strategic Plan — Ahead of the curve: shaping future-ready health systems.

The bedrock of the PMDE Program is the creation and coordination of CoLab — a real-world evidence generation network comprised of experts in applied research, drug evaluation methodologies, and data analysis. During the transition period from DSEN, CADTH invited proposals from contributors across Canada to become Core Network Partners and Network Collaborators within CoLab. A round of Request for Proposals for grant funding is planned to run annually each February­-to-April.

Collaboration across the CoLab Network is the linchpin of the PMDE Program. CADTH states “No single team is expected to have methodological expertise in all areas, but collectively, the network will include a varied and rich source of skill and capability to allow both safety and effectiveness queries to be answered in a timely, robust, and scientifically rigorous manner.”

CADTH’s PMDE Program became operationally active in place of DSEN on September 1^st, 2022. Its remit is to answer questions from senior government health-care decision-makers with timely, targeted evidence reviews based on real-world data. The PMDE Program strives to bring researchers and users of the information together to ensure the research conducted addresses identified information gaps relating to post-market drug safety and effectiveness.

The Program’s goals include creating a culture of continuous quality improvement for query response and fostering national and international PMDE partnerships to identify and streamline processes for improved post-market evaluation. The addition of PMDE to CADTH’s established role in management of earlier drug life cycle stages, such as pre-market advice, means that centralized consultation over whole drug life spans can facilitate cementing real-world PMDE as an integral part of every drug life cycle.