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 …

A review of big data and medical research

M Mallappallil, J Sabu, A Gruessner… - SAGE open …, 2020 - journals.sagepub.com
Universally, the volume of data has increased, with the collection rate doubling every 40
months, since the 1980s.“Big data” is a term that was introduced in the 1990s to include data …

[HTML][HTML] 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 …

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 …

Cardiovascular Outcomes in Patients Initiating First-Line Treatment of Type 2 Diabetes With Sodium–Glucose Cotransporter-2 Inhibitors Versus Metformin: A Cohort …

HJ Shin, S Schneeweiss, RJ Glynn… - Annals of internal …, 2022 - acpjournals.org
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 …

[HTML][HTML] HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: a good practices report …

SV Wang, A Pottegård, W Crown, P Arlett, DM Ashcroft… - Value in Health, 2022 - Elsevier
Objectives Ambiguity in communication of key study parameters limits the utility of real-world
evidence (RWE) studies in healthcare decision-making. Clear communication about data …

Durability of the single-dose Ad26. COV2. S vaccine in the prevention of COVID-19 infections and hospitalizations in the US before and during the Delta variant surge

JM Polinski, AR Weckstein, M Batech… - JAMA Network …, 2022 - jamanetwork.com
Importance Vaccination against the SARS-CoV-2 virus is critical to control the pandemic.
Randomized clinical trials demonstrated efficacy of the single-dose Ad26. COV2. S COVID …

Metformin and cancer: solutions to a real-world evidence failure

OHY Yu, S Suissa - Diabetes Care, 2023 - Am Diabetes Assoc
The quest to repurpose metformin, an antidiabetes drug, as an agent for cancer prevention
and treatment, which began in 2005 with an observational study that reported a reduction in …

Effectiveness and safety of apixaban compared with rivaroxaban for patients with atrial fibrillation in routine practice: a cohort study

M Fralick, M Colacci, S Schneeweiss… - Annals of internal …, 2020 - acpjournals.org
Background: Apixaban and rivaroxaban are the most commonly prescribed direct oral
anticoagulants for adults with atrial fibrillation, but head-to-head data comparing their safety …

[HTML][HTML] Real-world evidence: the devil is in the detail

M Gokhale, T Stürmer, JB Buse - Diabetologia, 2020 - Springer
Much has been written about real-world evidence (RWE), a concept that offers an
understanding of the effects of healthcare interventions using routine clinical data. The …