July 15, 2020

Active surveillance for Safety and Effectiveness of Health Products

Q# 19-03/18-08: Active surveillance for Safety and Effectiveness of Health Products

Research Question:

To conduct a systematic review of active surveillance methodologies and perform pilot studies on active surveillance using the Canadian Healthcare system data and other types of data that may inform pharmacovigilance in Canada.

Decision-making context:

The MHPD logic model specifies the ultimate program outcome of “sustainable, integrated, responsive and science-based national regulatory system”.  A more strategic approach to active surveillance that considers methodologies and resources suitable to the Canadian regulatory context would contribute to this outcome.

Further the ministerial mandate to address access, affordability and appropriate use has resulted in a Directorate initiative to enhance the use of real world evidence within the post-market arena.  A DSEN study could support MHPD’s advancement in the use of real world data to support decision-making.

This review will inform pro-active planning and help prioritize the use of third party research networks in meeting Health Canada’s active surveillance needs; the development of data analytics capacity within Health Canada; and the development of an active surveillance strategy.

Methodologies:

Traditional and emerging that would be suitable for drugs and devices for 1) safety surveillance and 2) effectiveness surveillance.

•Evaluation of existing tools and methodologies: characteristics, strengths, and limitations, resource requirements and sustainability considerations, suitability for Canadian applications given the current and potential future state of Canadian health systems data.

•Methodological guidelines building on those created by other organizations and identification of gaps or areas of focus where Canadian regulatory and policy initiatives could contribute to international active surveillance.

•A review and evaluation of privacy and governance models that could support a federal active surveillance strategy in Canada.

It is anticipated that this query might be answered with a scoping review, but other types of methodologies will be considered, including proposals of possible active surveillance pilot projects that help establish a federal approach to active surveillance within the context of Market Authorization Holder responsibilities to conduct active surveillance related to their authorized products.

FDA has developed key elements [i]that would be required to successfully implement an active surveillance strategy. The review could address some of these concerns at a high level, but the intent of the investigation is focused on methodologies and the feasibility of their implementation in Canada at a federal level.

Current status:

We have developed a website for the current study (motherchildcohort.ca). The methodology sharing platform has been developed and used by participating provinces/team members. The repository is underway but slow downed due to COVID-19. We have obtained a CIHR KT grant that allowed all team members to meet face-to-face in Montreal on February 20, 2020.