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 …
Healthcare professionals increasingly rely on observational healthcare data, such as administrative claims and electronic health records, to estimate the causal effects of …
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 …
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 …
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 …
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 …
Abstract Background The Observational Medical Outcomes Partnership (OMOP) has just completed a large scale empirical evaluation of statistical methods and analysis choices for …
Computational signal detection constitutes a key element of postmarketing drug monitoring and surveillance. Diverse data sources are considered within the 'search space'of …
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 …