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 …

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 …

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 …

Association between tumor necrosis factor inhibitors and the risk of hospitalization or death among patients with immune-mediated inflammatory disease and COVID …

Z Izadi, EJ Brenner, SK Mahil, N Dand… - JAMA network …, 2021 - jamanetwork.com
Importance Although tumor necrosis factor (TNF) inhibitors are widely prescribed globally
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

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 …

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 …

[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 …

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 …

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 …

Emulating a randomised controlled trial with observational data: an introduction to the target trial framework

SA Kutcher, JM Brophy, HR Banack… - Canadian Journal of …, 2021 - Elsevier
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 …