Real-world data: a brief review of the methods, applications, challenges and opportunities

F Liu, D Panagiotakos - BMC Medical Research Methodology, 2022 - Springer
Background The increased adoption of the internet, social media, wearable devices, e-
health services, and other technology-driven services in medicine and healthcare has led to …

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 …

Association of SARS-CoV-2 seropositive antibody test with risk of future infection

RA Harvey, JA Rassen, CA Kabelac… - JAMA internal …, 2021 - jamanetwork.com
Importance Understanding the effect of serum antibodies to severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) on susceptibility to infection is important for …

From hype to reality: data science enabling personalized medicine

H Fröhlich, R Balling, N Beerenwinkel, O Kohlbacher… - BMC medicine, 2018 - Springer
Abstract Background Personalized, precision, P4, or stratified medicine is understood as a
medical approach in which patients are stratified based on their disease subtype, risk …

Technology readiness levels for machine learning systems

A Lavin, CM Gilligan-Lee, A Visnjic, S Ganju… - Nature …, 2022 - nature.com
The development and deployment of machine learning systems can be executed easily with
modern tools, but the process is typically rushed and means-to-an-end. Lack of diligence …

Leveraging external data in the design and analysis of clinical trials in neuro-oncology

R Rahman, S Ventz, J McDunn, B Louv… - The Lancet …, 2021 - thelancet.com
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 …

The need for increased pragmatism in cardiovascular clinical trials

MS Usman, HGC Van Spall, SJ Greene… - Nature Reviews …, 2022 - nature.com
The majority of cardiovascular randomized controlled trials (RCTs) test interventions in
selected patient populations under explicitly protocol-defined settings. Although these …

[HTML][HTML] Machine learning in clinical trials: A primer with applications to neurology

MI Miller, LC Shih, VB Kolachalama - Neurotherapeutics, 2023 - Elsevier
We reviewed foundational concepts in artificial intelligence (AI) and machine learning (ML)
and discussed ways in which these methodologies may be employed to enhance progress …

Generating real-world tumor burden endpoints from electronic health record data: comparison of RECIST, radiology-anchored, and clinician-anchored approaches for …

SD Griffith, M Tucker, B Bowser, G Calkins, C Chang… - Advances in …, 2019 - Springer
Introduction Real-world evidence derived from electronic health records (EHRs) is
increasingly recognized as a supplement to evidence generated from traditional clinical …

Real‐world evidence to support regulatory decision‐making for medicines: considerations for external control arms

M Burcu, NA Dreyer, JM Franklin… - … and drug safety, 2020 - Wiley Online Library
Randomized clinical trials (RCTs) are the gold standard in producing clinical evidence of
efficacy and safety of medical interventions. More recently, a new paradigm is emerging …