Defining a reference set to support methodological research in drug safety
Background Methodological research to evaluate the performance of methods requires a
benchmark to serve as a referent comparison. In drug safety, the performance of analyses of …
benchmark to serve as a referent comparison. In drug safety, the performance of analyses of …
Methods for safety signal detection in healthcare databases: a literature review
Introduction: With increasing availability, the use of healthcare databases as complementary
data source for drug safety signal detection has been explored to circumvent the limitations …
data source for drug safety signal detection has been explored to circumvent the limitations …
[HTML][HTML] How confident are we about observational findings in healthcare: a benchmark study
Healthcare professionals increasingly rely on observational healthcare data, such as
administrative claims and electronic health records, to estimate the causal effects of …
administrative claims and electronic health records, to estimate the causal effects of …
A comparison of the empirical performance of methods for a risk identification system
Background Observational healthcare data offer the potential to enable identification of risks
of medical products, and the medical literature is replete with analyses that aim to …
of medical products, and the medical literature is replete with analyses that aim to …
Bridging islands of information to establish an integrated knowledge base of drugs and health outcomes of interest
The entire drug safety enterprise has a need to search, retrieve, evaluate, and synthesize
scientific evidence more efficiently. This discovery and synthesis process would be greatly …
scientific evidence more efficiently. This discovery and synthesis process would be greatly …
[HTML][HTML] Toward multimodal signal detection of adverse drug reactions
R Harpaz, W DuMouchel, M Schuemie… - Journal of biomedical …, 2017 - Elsevier
Objective Improving mechanisms to detect adverse drug reactions (ADRs) is key to
strengthening post-marketing drug safety surveillance. Signal detection is presently …
strengthening post-marketing drug safety surveillance. Signal detection is presently …
Electronic health data for postmarket surveillance: a vision not realized
TJ Moore, CD Furberg - Drug Safety, 2015 - Springer
What has been learned about electronic health data as a primary data source for regulatory
decisions regarding the harms of drugs? Observational studies with electronic health data …
decisions regarding the harms of drugs? Observational studies with electronic health data …
Replication of the OMOP experiment in Europe: evaluating methods for risk identification in electronic health record databases
Abstract Background The Observational Medical Outcomes Partnership (OMOP) has just
completed a large scale empirical evaluation of statistical methods and analysis choices for …
completed a large scale empirical evaluation of statistical methods and analysis choices for …
Computational approaches for pharmacovigilance signal detection: toward integrated and semantically-enriched frameworks
VG Koutkias, MC Jaulent - Drug safety, 2015 - Springer
Computational signal detection constitutes a key element of postmarketing drug monitoring
and surveillance. Diverse data sources are considered within the 'search space'of …
and surveillance. Diverse data sources are considered within the 'search space'of …
The State of Use and Utility of Negative Controls in Pharmacoepidemiologic Studies
Uses of real-world data in drug safety and effectiveness studies are often challenged by
various sources of bias. We undertook a systematic search of the published literature …
various sources of bias. We undertook a systematic search of the published literature …