Signal Detection for Recently Approved Products: Adapting and Evaluating Self-Controlled Case Series Method Using a US Claims and UK Electronic Medical Records Database

Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association

(2016) Susan Gruber et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Hepatic outcomes among adults taking duloxetine: a retrospective cohort study in a US health care claims database

(2015) Nancy D. Lin et al.   BMC GASTROENTEROLOGY

Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection

(2015) Alexandra C. Pacurariu et al.   DRUG SAFETY

Antipsychotic drugs and risks of myocardial infarction: a self-controlled case series study

(2014) R. Brauer et al.   EUROPEAN HEART JOURNAL

Multiple Self-Controlled Case Series for Large-Scale Longitudinal Observational Databases

(2013) Shawn E. Simpson et al.   BIOMETRICS

Empirical Performance of the Calibrated Self-Controlled Cohort Analysis Within Temporal Pattern Discovery: Lessons for Developing a Risk Identification and Analysis System

(2013) G. Niklas Norén et al.   DRUG SAFETY

Empirical Performance of the Self-Controlled Case Series Design: Lessons for Developing a Risk Identification and Analysis System

(2013) Marc A. Suchard et al.   DRUG SAFETY

Defining a Reference Set to Support Methodological Research in Drug Safety

(2013) Patrick B. Ryan et al.   DRUG SAFETY

An Evaluation of the THIN Database in the OMOP Common Data Model for Active Drug Safety Surveillance

(2013) Xiaofeng Zhou et al.   DRUG SAFETY

A simulation study to compare three self-controlled case series approaches: correction for violation of assumption and evaluation of bias

(2013) Wei Hua et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Learning From Epidemiology: Interpreting Observational Database Studies for the Effects of Medical Products

(2013) Patrick Ryan et al.   Statistics in Biopharmaceutical Research

Orlistat and the risk of acute liver injury: self controlled case series study in UK Clinical Practice Research Datalink

(2013) I. J. Douglas et al.   BMJ-British Medical Journal

Safety surveillance of longitudinal databases: results on real-world data

(2012) G. Niklas Norén et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Empirical assessment of methods for risk identification in healthcare data: results from the experiments of the Observational Medical Outcomes Partnership

(2012) Patrick B. Ryan et al.   STATISTICS IN MEDICINE

Use of the self-controlled case series method in drug safety assessment

(2011) Anthony Grosso et al.   Expert Opinion On Drug Safety

Selective serotonin reuptake inhibitor treatment and risk of fractures: a meta-analysis of cohort and case–control studies

(2011) Q. Wu et al.   OSTEOPOROSIS INTERNATIONAL

An Evaluation of Three Signal-Detection Algorithms Using a Highly Inclusive Reference Event Database

(2009) Alan M. Hochberg et al.   DRUG SAFETY

Risk of Herpes Zoster in Patients With Rheumatoid Arthritis Treated With Anti–TNF-α Agents

(2009) Anja Strangfeld   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Quantitative signal detection using spontaneous ADR reporting

(2009) A. Bate et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor?

(2009) Gianluca Trifirò et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

The Risk of Fractures Associated with Thiazolidinediones: A Self-controlled Case-Series Study

(2009) Ian J. Douglas et al.   PLOS MEDICINE

Impact of Stratification on Adverse Drug Reaction Surveillance

(2008) Johan Hopstadius et al.   DRUG SAFETY

The methodology of self-controlled case series studies

(2008) Heather J Whitaker et al.   STATISTICAL METHODS IN MEDICAL RESEARCH