Use of real‐world evidence to drive drug development strategy and inform clinical trial design
S Dagenais, L Russo, A Madsen… - Clinical …, 2022 - Wiley Online Library
Interest in real‐world data (RWD) and real‐world evidence (RWE) to expedite and enrich the
development of new biopharmaceutical products has proliferated in recent years, spurred by …
development of new biopharmaceutical products has proliferated in recent years, spurred 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 …
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 …
Association between tumor necrosis factor inhibitors and the risk of hospitalization or death among patients with immune-mediated inflammatory disease and COVID …
Importance Although tumor necrosis factor (TNF) inhibitors are widely prescribed globally
because of their ability to ameliorate shared immune pathways across immune-mediated …
because of their ability to ameliorate shared immune pathways across immune-mediated …
Emulating randomized clinical trials with nonrandomized real-world evidence studies: first results from the RCT DUPLICATE initiative
Background: Regulators are evaluating the use of noninterventional real-world evidence
(RWE) studies to assess the effectiveness of medical products. The RCT DUPLICATE …
(RWE) studies to assess the effectiveness of medical products. The RCT DUPLICATE …
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 …
and treatment, which began in 2005 with an observational study that reported a reduction in …
[HTML][HTML] Digital health COVID-19 impact assessment: lessons learned and compelling needs
P Lee, A Abernethy, D Shaywitz, AV Gundlapalli… - NAM …, 2022 - ncbi.nlm.nih.gov
This discussion paper is part of the National Academy of Medicine's Emerging Stronger After
COVID-19: Priorities for Health System Transformation initiative, which commissioned …
COVID-19: Priorities for Health System Transformation initiative, which commissioned …
Trends in the use of oral anticoagulants for adults with venous thromboembolism in the US, 2010-2020
GS Iyer, H Tesfaye, NF Khan, H Zakoul… - JAMA Network …, 2023 - jamanetwork.com
Importance The introduction of direct oral anticoagulants (DOACs) has transformed the
treatment of venous thromboembolism (VTE). Large health care databases offer valuable …
treatment of venous thromboembolism (VTE). Large health care databases offer valuable …
Application of real-world data to external control groups in oncology clinical trial drug development
TA Yap, I Jacobs, E Baumfeld Andre, LJ Lee… - Frontiers in …, 2022 - frontiersin.org
Randomized controlled trials (RCTs) that assess overall survival are considered the “gold
standard” when evaluating the efficacy and safety of a new oncology intervention. However …
standard” when evaluating the efficacy and safety of a new oncology intervention. However …
Emulating a randomised controlled trial with observational data: an introduction to the target trial framework
Randomised controlled trials (RCTs) are often considered to be the highest quality of
evidence owing to the absence of baseline confounding, the simplicity of analyses, and …
evidence owing to the absence of baseline confounding, the simplicity of analyses, and …