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

S Schneeweiss, E Patorno - Endocrine Reviews, 2021 - academic.oup.com
Abstract Real-world evidence (RWE), the understanding of treatment effectiveness in clinical
practice generated from longitudinal patient-level data from the routine operation of the …

Evaluating the use of nonrandomized real‐world data analyses for regulatory decision making

JM Franklin, RJ Glynn, D Martin… - Clinical Pharmacology …, 2019 - Wiley Online Library
The analysis of longitudinal healthcare data outside of highly controlled parallel‐group
randomized trials, termed real‐world evidence (RWE), has received increasing attention in …

Emulation of randomized clinical trials with nonrandomized database analyses: results of 32 clinical trials

SV Wang, S Schneeweiss, JM Franklin, RJ Desai… - Jama, 2023 - jamanetwork.com
Importance Nonrandomized studies using insurance claims databases can be analyzed to
produce real-world evidence on the effectiveness of medical products. Given the lack of …

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

SM Langan, SAJ Schmidt, K Wing, V Ehrenstein… - bmj, 2018 - bmj.com
In pharmacoepidemiology, routinely collected data from electronic health records (including
primary care databases, registries, and administrative healthcare claims) are a resource for …

Association of remdesivir treatment with mortality among hospitalized adults with COVID-19 in the United States

AP Chokkalingam, J Hayden, JD Goldman… - JAMA Network …, 2022 - jamanetwork.com
Importance SARS-CoV-2, which causes COVID-19, poses considerable morbidity and
mortality risks. Studies using data collected during routine clinical practice can supplement …

Network-based approach to prediction and population-based validation of in silico drug repurposing

F Cheng, RJ Desai, DE Handy, R Wang… - Nature …, 2018 - nature.com
Here we identify hundreds of new drug-disease associations for over 900 FDA-approved
drugs by quantifying the network proximity of disease genes and drug targets in the human …

Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions

SV Wang, SK Sreedhara, S Schneeweiss - Nature communications, 2022 - nature.com
Studies that generate real-world evidence on the effects of medical products through
analysis of digital data collected in clinical practice provide key insights for regulators …

STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies

SV Wang, S Pinheiro, W Hua, P Arlett, Y Uyama… - Bmj, 2021 - bmj.com
In alignment with the International Council of Harmonization's strategic goals, a public-
private consortium has developed a structured template for planning and reporting on the …

Emulating randomized clinical trials with nonrandomized real-world evidence studies: first results from the RCT DUPLICATE initiative

JM Franklin, E Patorno, RJ Desai, RJ Glynn, D Martin… - Circulation, 2021 - Am Heart Assoc
Background: Regulators are evaluating the use of noninterventional real-world evidence
(RWE) studies to assess the effectiveness of medical products. The RCT DUPLICATE …

Risk of diabetic ketoacidosis after initiation of an SGLT2 inhibitor

M Fralick, S Schneeweiss… - New England Journal of …, 2017 - Mass Medical Soc
Risk of Diabetic Ketoacidosis after Initiation of an SGLT2 Inhibitor Page 1 Correspondence The
new england journal of medicine n engl j med 376;23 nejm.org June 8, 2017 2300 …