Observational studies of drug safety in multi-database studies: Methodological challenges and opportunities

Observational studies of drug safety in multi-database studies: Methodological challenges and opportunities

Overview

What is the aim of the study?

The Canadian Network for Observational Drug Effect Studies (CNODES), a network of researchers and databases, is a collaborating center of the Drug Safety and Effectiveness Network. CNODES’ main mandate is to conduct observational studies of drug safety based on queries developed and submitted by Health Canada and other federal, provincial, and territorial stakeholders. Through a case study we explore several methodological opportunities and challenges that arise in distributed pharmacoepidemiology networks.

How was the study conducted?

We use as a case study a study of proton pump inhibitors and hospitalization for communityacquired pneumonia. Challenges arise in the design and conduct of studies at individual sites, and then with processes and methods for combining data. On the other hand, distributed networks provide opportunities, such as the ability to detect and understand heterogeneity, in sample sizes that would typically be impossible for a single study.

What did the study find?

Networks such as CNODES provide the opportunity to detect and quantify important safety signals from administrative data, and provide many challenges for methods research in pharmacoepidemiology using distributed data. As networks increase in size and scope of research questions, the need for methodological developments should continue to grow.

Manuscripts

Platt RW, Dormuth CR, Chateau D, Filion K. Observational Studies of Drug Safety in Multi-Database Studies: Methodological Challenges and Opportunities. EGEMS (Wash DC). 2016 May 18;4(1):1221.

Presentations

Project Team

Project Lead
Robert W. Platt PhD
CPRD
Collaborator
Kristian Filion PhD
CPRD
Collaborator
Dan Chateau PhD
Manitoba
Collaborator
Colin R. Dormuth ScD
British Columbia