Results 261 to 270 of about 2,671,764 (310)

Real‐world evidence in pediatrics

Pediatric Allergy and Immunology
non ...
M. Giovannini, Francesco Catamerò, I. Agache, A. Bognanni, G. Canonica, S. D. Del Giacco, E. Heffler, M. Lenge, M. Leo, F. Mori, N. Papadopoulos, G. Paoletti, Holger J. Schünemann, B. Sousa‐Pinto, M. Erlewyn‐Lajeunesse   +14 more
semanticscholar   +3 more sources

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, 2017
Le evidenze derivate dal mondo reale, basate su database elettronici sanitari, registri di malattia o di prodotto e studi osservazionali, sono fra i temi più discussi nell’ambito dei congressi medici. Al fine di facilitare l’approvazione di nuove terapie e di nuovi dispositivi, le evidenze dal mondo reale si rivelano un utile strumento a supporto dei ...
Luca, De Fiore, Antonio, Addis
openaire   +2 more sources

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

TriNetX and Real-World Evidence: A Critical Review of Its Strengths, Limitations, and Bias Considerations in Clinical Research

ASIDE internal medicine
Introduction: The increasing utilization of real-world data platforms in medical research necessitates a comprehensive understanding of their methodological strengths and limitations.
Mahmoud Nassar, Hazem Abosheaishaa, Khaled Elfert, Azizullah Beran, Abdellatif Ismail, Mouhand F. H. Mohamed, Anoop Misra, M. Essibayi, David J. Altschul, A. Azzam   +9 more
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, A. Kishtagari, J. Zeidner, Catherine C Coombs, Y. Madanat, Stephen S. Chung, T. Badar, James M. Foran, Pinkal M. Desai, C. Tsai, Elizabeth A. 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

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

Real-world data and real-world evidence

Abstract Real-world data (RWD) can be described as routinely collected data from a variety of sources other than traditional clinical trials. A summary of the status of the use of real-world evidence (RWE) in regulatory decision-making is provided.
Phil Ambery, Adrian Kilcoyne, Daniel O’Connor   +2 more
openaire   +1 more source