Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review
E Bosco, L Hsueh, KW McConeghy… - BMC Medical Research …, 2021 - Springer
Background Major adverse cardiovascular events (MACE) are increasingly used as
composite outcomes in randomized controlled trials (RCTs) and observational studies …
composite outcomes in randomized controlled trials (RCTs) and observational studies …
The role of real‐world evidence in FDA‐approved new drug and biologics license applications
CA Purpura, EM Garry, N Honig… - Clinical …, 2022 - Wiley Online Library
The US Food and Drug Administration (FDA) is open to accepting real‐world evidence
(RWE) to support its assessment of medical products. However, RWE stakeholders lack a …
(RWE) to support its assessment of medical products. However, RWE stakeholders lack a …
Emulation of randomized clinical trials with nonrandomized database analyses: results of 32 clinical trials
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 …
produce real-world evidence on the effectiveness of medical products. Given the lack of …
Prospective cohort of fluvoxamine for early treatment of coronavirus disease 19
D Seftel, DR Boulware - Open Forum Infectious Diseases, 2021 - academic.oup.com
We report a real-world experience using fluvoxamine for coronavirus disease 19 (COVID-
19) in a prospective cohort in the setting of a mass outbreak. Overall, 65 persons opted to …
19) in a prospective cohort in the setting of a mass outbreak. Overall, 65 persons opted to …
Reporting of observational studies explicitly aiming to emulate randomized trials: a systematic review
Importance Observational (nonexperimental) studies that aim to emulate a randomized trial
(ie, the target trial) are increasingly informing medical and policy decision-making, but it is …
(ie, the target trial) are increasingly informing medical and policy decision-making, but it is …
Real-world evidence: a primer
A Dang - Pharmaceutical medicine, 2023 - Springer
Real-world evidence (RWE) is clinical evidence on a medical product's safety and efficacy
that is generated using real-world data (RWD) resulting from routine healthcare delivery …
that is generated using real-world data (RWD) resulting from routine healthcare delivery …
Timing of dialysis initiation to reduce mortality and cardiovascular events in advanced chronic kidney disease: nationwide cohort study
Objective To identify the optimal estimated glomerular filtration rate (eGFR) at which to
initiate dialysis in people with advanced chronic kidney disease. Design Nationwide …
initiate dialysis in people with advanced chronic kidney disease. Design Nationwide …
Leveraging external data in the design and analysis of clinical trials in neuro-oncology
Integration of external control data, with patient-level information, in clinical trials has the
potential to accelerate the development of new treatments in neuro-oncology by …
potential to accelerate the development of new treatments in neuro-oncology by …
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 …
practice generated from longitudinal patient-level data from the routine operation of the …
Cardiovascular Outcomes in Patients Initiating First-Line Treatment of Type 2 Diabetes With Sodium–Glucose Cotransporter-2 Inhibitors Versus Metformin: A Cohort …
Background: Evidence on the risk for cardiovascular events associated with use of first-line
sodium–glucose cotransporter-2 inhibitors (SGLT-2i) compared with metformin is limited …
sodium–glucose cotransporter-2 inhibitors (SGLT-2i) compared with metformin is limited …