The Establishment of the Canadian Network for Observational Drug Effect Studies (cNODES)

Background: In Canada the provinces and territories provide universal healthcare. Coverage of pharmaceuticals is variable but complete at 65 years in all jurisdictions. Prescribing can be linked to outpatient and inpatient data, vital statistics and specialized registries. There is a long history of performing studies of drug effects in several provinces, and there is a strong community of capable researchers.

Objectives: To coordinate and enhance existing resources to create a national network.

Methods: In 2009 the Government of Canada committed funds to create a Drug safety and Effectiveness Network under the Food and Consumer Safety Action Plan. This was part of an agreement to introduce progressive licensing for new drugs. In Canada the relevant data ‐ sets are created and maintained by the Provinces. In January 2011 funding was awarded to a consortium, comprising researchers in British Columbia, Alberta, Saskatchewan, Manitoba, Ontario and the Maritimes, led and co ‐ ordinated in Quebec.

Results: This initiative has established a network with an insured population of 27 million. The science is supported by data ‐ base, methods, capacity building and knowledge translation groups. The first development involves the creation of a network of linked provincial data repositories with pharmaco ‐ epidemiologists and technical staff at each site. The scientific work involves the development of common protocols and supporting instruments such as data dictionaries and algorithms. The early work will be done under a model of academic collaboration with modification of core protocols to enable analyses to be tailored at each site to cope with the demands of provincial data repositories. Initial demonstration projects include investigation of high dose statin use as a cause of renal failure and acid pump inhibitors as a cause of community ‐ acquired pneumonia.

Conclusions: The longer term plan is to establish a distributed network of common core data sets that can be queried remotely using common code. The creation of cNODES represents a substantial investment in pharmaco ‐ epidemiology by the Government of Canada, and has already established an unprecedented level of academic collaboration.