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

S Schneeweiss - Clinical epidemiology, 2018 - Taylor & Francis
Background Decision makers in health care increasingly rely on nonrandomized database
analyses to assess the effectiveness, safety, and value of medical products. Health care data …

Transparency and reproducibility of observational cohort studies using large healthcare databases.

SV Wang, P Verpillat, JA Rassen… - Clinical …, 2016 - Wiley Online Library
The scientific community and decision‐makers are increasingly concerned about
transparency and reproducibility of epidemiologic studies using longitudinal healthcare …

Assessing the benefits and harms of pharmacotherapy in older adults with frailty: insights from pharmacoepidemiologic studies of routine health care data

DH Kim, CM Park, D Ko, KJ Lin, RJ Glynn - Drugs & Aging, 2024 - Springer
The objective of this review is to summarize and appraise the research methodology,
emerging findings, and future directions in pharmacoepidemiologic studies assessing the …

Relative performance of propensity score matching strategies for subgroup analyses

SV Wang, Y **, B Fireman, S Gruber… - American journal of …, 2018 - academic.oup.com
Postapproval drug safety studies often use propensity scores (PSs) to adjust for a large
number of baseline confounders. These studies may involve examining whether treatment …

Real world data in adaptive biomedical innovation: a framework for generating evidence fit for decision‐making

S Schneeweiss, HG Eichler… - Clinical …, 2016 - Wiley Online Library
Analyses of healthcare databases (claims, electronic health records [EHRs]) are useful
supplements to clinical trials for generating evidence on the effectiveness, harm, use, and …

The State of Use and Utility of Negative Controls in Pharmacoepidemiologic Studies

Z Zafari, J Park, CH Shah, S Dosreis… - American Journal of …, 2024 - academic.oup.com
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 …

Successful comparison of US Food and Drug Administration sentinel analysis tools to traditional approaches in quantifying a known drug‐adverse event association

JJ Gagne, X Han, S Hennessy… - Clinical …, 2016 - Wiley Online Library
The US Food and Drug Administration's Sentinel system has developed the capability to
conduct active safety surveillance of marketed medical products in a large network of …

Prospective postmarketing surveillance of acute myocardial infarction in new users of saxagliptin: a population-based study

S Toh, ME Reichman, DJ Graham, C Hampp… - Diabetes …, 2018 - Am Diabetes Assoc
OBJECTIVE The cardiovascular safety of saxagliptin, a dipeptidyl-peptidase 4 inhibitor,
compared with other antihyperglycemic treatments is not well understood. We prospectively …

Real-world data analytics fit for regulatory decision-making

S Schneeweiss, RJ Glynn - American journal of law & medicine, 2018 - cambridge.org
Healthcare database analyses (claims, electronic health records) have been identified by
various regulatory initiatives, including the 21st Century Cures Act and Prescription Drug …

A methodological review of the high-dimensional propensity score in comparative-effectiveness and safety-of-interventions research finds incomplete reporting …

GL Martin, C Petri, J Rozenberg, N Simon… - Journal of Clinical …, 2024 - Elsevier
Objectives The use of secondary databases has become popular for evaluating the
effectiveness and safety of interventions in real-life settings. However, the absence of …