Results 261 to 270 of about 2,242,374 (316)

Real-World Evidence - Where Are We Now?

New England Journal of Medicine, 2022
M than 5 years after the passage of the 21st Century Cures Act of 2016, the terms “realworld data” (RWD) and “real-world evidence” (RWE) are being used inconsistently and sometimes interchangeably.
J. Concato, Jacqueline Corrigan-Curay
semanticscholar   +1 more source

[Real-world evidence.]

Recenti progressi in medicina, 2018
Real-world evidence is among the most frequently discussed issues at professional medical conferences and meetings. It refers to data and information derived from sources such as electronic health records, disease or product registries, and observational research.
Luca De Fiore, Antonio Addis
openaire   +2 more sources

Guidelines of the International Headache Society for Real-World Evidence studies in migraine and cluster headache

Cephalalgia
Real-world evidence studies are an important tool for investigating the effectiveness, safety and tolerability of treatments for headache disorders in clinical practice.
P. Pozo‐Rosich, N. van Veelen, E. Caronna, G. Vaghi, M. Torres-Ferrús, Britt W. H. van der Arend, P. Goadsby, M. Ashina, Shuu-Jiun Wang, H. Diener, Cristina Tassorelli, G. Terwindt   +11 more
semanticscholar   +1 more source

Real-World Evidence in the Real World: Beyond the FDA

American Journal of Law & Medicine, 2018
The 21st Century Cures Act (“Cures Act”) relies on the concept of real-world evidence (“RWE”) to improve the Food and Drug Administration (“FDA”) approval process. This has amplified interest and furthered momentum in applying RWE more broadly, beyond FDA regulation.
Joan H, Krause, Richard S, Saver
openaire   +2 more sources

Real-World Evidence of Automated Insulin Delivery System Use

Diabetes Technology & Therapeutics
Objective: Pivotal trials of automated insulin delivery (AID) closed-loop systems have demonstrated a consistent picture of glycemic benefit, supporting approval of multiple systems by the Food and Drug Administration or Conformité Européenne mark ...
Elizabeth G Considine, J. Sherr
semanticscholar   +1 more source

Risk prediction for clonal cytopenia: multicenter real-world evidence

Blood
Key Points • A 3-parameter CCRS model was devised specifically for patients diagnosed with clonal cytopenia.• The CCRS offers precise CCUS risk assessment for patient management and clinical trial eligibility.
Zhuoer Xie, R. Komrokji, Najla Al-Ali, Alexandra N. Regelson, Susan Geyer, A. Patel, C. Saygin, A. Zeidan, J. Bewersdorf, Lourdes M Mendez, Ashwin Kishtagari, J. Zeidner, Catherine C Coombs, Y. Madanat, Stephen S. Chung, T. Badar, James M. Foran, Pinkal M. Desai, Charlton Tsai, E. Griffiths, M. A. Al Malki, Idoroenyi Amanam, Catherine Lai, H. Deeg, L. Adès, C. Arana-Yi, Afaf E G Osman, S. Dinner, Y. Abaza, Justin Taylor, N. Chandhok, Deborah Soong, Andrew M. Brunner, H. Carraway, Abhay Singh, Chiara Elena, Jacqueline Ferrari, A. Gallì, Sara Pozzi, E. Padron, Mirinal S Patnaik, L. Malcovati, M. Savona, A. Al-Kali   +43 more
semanticscholar   +1 more source