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iGlarLixi vs. premixed insulin initiation in adults with type 2 diabetes advancing from basal insulin therapy: SoliComplex real-world study
Aim To compare outcomes in adults with type 2 diabetes (T2D) suboptimally controlled with ...
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Evaluation of VTE, MACE, and serious infections among patients with RA treated with baricitinib compared to TNFi: a multi-database study of patients in routine care using disease registries and claims
Introduction The aim of this work is to evaluate baricitinib safety with respect to ...
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Effects of expanding the look‐back period to all available data in the assessment of covariates
Background A fixed baseline period has been a common covariate assessment approach in ...
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Transferability of real-world data across borders for regulatory and health technology assessment decision-making
Recently, there has been increased consideration of real-world data (RWD) and real-world ...
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Diagnosis-wide analysis of COVID-19 complications: an exposure-crossover study
Background: Many studies reporting coronavirus disease 2019 (COVID-19) complications have ...
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Adherence to Chronic Kidney Disease Screening Guidelines Among Patients With Type 2 Diabetes in a US Administrative Claims Database
Objective To examine the screening rates for kidney damage and function among patients ...
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SURF: A Screening tool (for manufacturers) to evaluate whether Using real-world data to support an effectiveness claim in an FDA application has Regulatory Feasibility
Based on recent guidance and publicly available approvals, the US Food and Drug ...
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The Structured Process to Identify Fit-For-Purpose Data: A Data Feasibility Assessment Framework
To complement real-world evidence (RWE) guidelines, the 2019 Structured Preapproval and ...
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Characteristics of adults newly diagnosed with idiopathic hypersomnia in the United States
Background Idiopathic hypersomnia is a debilitating sleep disorder; however, little is ...
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[RCT-D] Non-randomized healthcare database studies and their agreement with 32 emulated randomized controlled trials
Importance Nonrandomized studies using insurance claims databases can be analyzed to ...
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The Aetion Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation (CARE) Initiative: Oncology
Legislative and technological advancements over the past decade have given rise to the ...
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Drug utilization patterns and adherence in patients on systemic medications for the treatment of psoriasis: A retrospective, comparative cohort study
Background: Nonadherence to systemic treatments for psoriasis leads to treatment failure ...
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Advancing digital health applications: priorities for innovation in real-world evidence generation
In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a ...
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"An epidemiological model to estimate the prevalence of diffuse large B-cell lymphoma in the United States"
Background: Prevalence is reflective of disease incidence and survival, and defined as ...
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Single-arm oncology trials and the nature of external controls arms
Aim: Single-arm trials with external control arms (ECAs) have gained popularity in ...
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Treatment Transitions in Chronic Obstructive Pulmonary Disease: Retrospective Analyses of US and UK Healthcare Databases
Introduction Previous studies have reported that more patients receive inhaled ...
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Characteristics and outcomes of pregnancies in the Maternal Outcomes Masterset real-world database
Purpose Describe patient characteristics and pregnancy outcomes among all pregnant ...
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Real-world data suggest antibody positivity to SARS-CoV-2 is associated with a decreased risk of future infection
Importance There is limited evidence regarding whether the presence of serum antibodies ...
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Glucose‐lowering medications and the risk of cancer: a methodological review of studies based on real‐world data
Aim To review the methodology of observational studies examining the association between ...
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The use of narrative electronic prescribing instructions in pharmacoepidemiology: A scoping review for the International Society for Pharmacoepidemiology
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Real-world evidence of stroke prevention in patients with nonvalvular atrial fibrillation in the United States: the REVISIT-US study
Background: Little data exists regarding the effectiveness and safety of rivaroxaban or ...
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The role of real-world evidence in FDA-approved New Drug and Biologics License Applications
The US Food and Drug Administration (FDA) is open to accepting real-world evidence (RWE) ...
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Real‐world evidence for assessing pharmaceutical treatments in the context of COVID‐19
The emergence and global spread of the severe acute respiratory syndrome coronavirus 2 ...
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Duration of Protection Against SARS-CoV-2 Reinfection and Associated Risk of Reinfection Assessed with Real-World Data
This retrospective observational study aimed to gain a better understanding of the ...