Broadening the reach of the FDA Sentinel system: A roadmap for integrating electronic health record data in a causal analysis framework

A General Propensity Score for Signal Identification using Tree-Based Scan Statistics

(2021) Shirley V Wang et al.   AMERICAN JOURNAL OF EPIDEMIOLOGY

Conducting real-world evidence studies on the clinical outcomes of diabetes treatments

(2021) Sebastian Schneeweiss et al.   ENDOCRINE REVIEWS

Identification and validation of anaphylaxis using electronic health data in a population-based setting

(2021) Maralyssa A. Bann et al.   EPIDEMIOLOGY

Electronic phenotyping of health outcomes of interest using a linked claims-electronic health record database: Findings from a machine learning pilot project

(2021) Teresa B Gibson et al.   JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION

Adaptive Validation Design

(2020) Lindsay J. Collin et al.   EPIDEMIOLOGY

Emulating Randomized Clinical Trials with Nonrandomized Real-World Evidence Studies: First Results from the RCT DUPLICATE Initiative

(2020) Jessica M. Franklin et al.   CIRCULATION

Towards Drug Safety Surveillance and Pharmacovigilance: Current Progress in Detecting Medication and Adverse Drug Events from Electronic Health Records

(2019) Feifan Liu et al.   DRUG SAFETY

Choosing Among Common Data Models for Real World Data Analyses Fit for Making Decisions about the Effectiveness of Medical Products

(2019) Sebastian Schneeweiss et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Using Super Learner Prediction Modeling to Improve High-dimensional Propensity Score Estimation

(2018) Richard Wyss et al.   EPIDEMIOLOGY

Automated data-adaptive analytics for electronic healthcare data to study causal treatment effects

(2018) Sebastian Schneeweiss   Clinical Epidemiology

Data Mining for Adverse Drug Events With a Propensity Score-matched Tree-based Scan Statistic

(2018) Shirley V. Wang et al.   EPIDEMIOLOGY

Evaluating automated approaches to anaphylaxis case classification using unstructured data from the FDA Sentinel System

(2018) Robert Ball et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

The FDA Sentinel Initiative — An Evolving National Resource

(2018) Richard Platt et al.   NEW ENGLAND JOURNAL OF MEDICINE

The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE)

(2018) Sinéad M Langan et al.   BMJ-British Medical Journal

Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available: Table 1.

(2016) Miguel A. Hernán et al.   AMERICAN JOURNAL OF EPIDEMIOLOGY

Quantitative Bias Analysis in Regulatory Settings

(2016) Timothy L. Lash et al.   AMERICAN JOURNAL OF PUBLIC HEALTH

The FDA's sentinel initiative-A comprehensive approach to medical product surveillance

(2016) R Ball et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Prevalent new-user cohort designs for comparative drug effect studies by time-conditional propensity scores

(2016) Samy Suissa et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Integrating database knowledge and epidemiological design to improve the implementation of data mining methods that evaluate vaccine safety in large healthcare databases

(2014) Jennifer C. Nelson et al.   Statistical Analysis and Data Mining

Targeted maximum likelihood estimation in safety analysis

(2013) Samuel D. Lendle et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY