ArticleEGEMS (Washington, DC)2016
Observational Studies of Drug Safety in Multi-Database Studies: Methodological Challenges and Opportunities.
Article in EGEMS (Washington, DC), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed.
- Core Concepts in Pharmacoepidemiology: Multi-Database Distributed Data Networks.Pharmacoepidemiology and drug safety · 2025Review
- Perspective review: Will generative AI make common data models obsolete in future analyses of distributed data networks?Therapeutic advances in drug safety · 2025Review
- Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model.Frontiers in medicine · 2021Article
- Analytic and Data Sharing Options in Real-World Multidatabase Studies of Comparative Effectiveness and Safety of Medical Products.Clinical pharmacology and therapeutics · 2020Review
- Building a framework for the evaluation of knowledge translation for the Canadian Network for Observational Drug Effect Studies.Pharmacoepidemiology and drug safety · 2020Article
- Combining distributed regression and propensity scores: a doubly privacy-protecting analytic method for multicenter research.Clinical epidemiology · 2018Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
INTRODUCTION/
objectiveThe 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. CASE STUDY: We use as a case study a study of proton pump inhibitors and hospitalization for community-acquired 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.
conclusionsNetworks 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.