Results 11 to 20 of about 8,452 (228)

RWE in Europe Paper III: A Roadmap for RWE [PDF]

, 2017
Real world evidence (RWE) has been touted as a remedy for current market access issues, facilitating quicker approvals and increased odds of reimbursement at a good price. It is therefore an attractive avenue for pursuit for manufacturers today. This paper, the third in a series looking at the use of RWE in Europe, outlines the discussions held between
Gill, Jennifer, Albanell, Joan, Avouac, Bernard, Berger, Karin, Boerlum Kristensen, Finn, Bucher, Heiner, Duncombe, Robert, Fink-Wagner, Antje-Henriette, Hutton, John, Jahnz-Różyk, Karina, Kossler, Ingrid, Podrazilova, Katerina, Spandonaro, Federico, Thomas, Michael, Vaz-Carneiro, Antonio, Wartenberg, Markus, Kanavos, Panos   +16 more
core   +4 more sources

Real world evidence (RWE) – a disruptive innovation or the quiet evolution of medical evidence generation? [version 1; referees: 2 approved] [PDF]

F1000Research, 2018
Stakeholders in healthcare are increasingly turning to real world evidence (RWE) to inform their decisions, alongside evidence from randomized controlled trials.
Sajan Khosla, Robert White, Jesús Medina, Mario Ouwens, Cathy Emmas, Tim Koder, Gary Male, Sandra Leonard   +7 more
doaj   +2 more sources

STaRT-RWE: structured template for planning and reporting on the implementation of real-world evidence studies [PDF]

Реальная клиническая практика: данные и доказательства, 2022
Aim. To highlight the features of STaRT-RWE (a structured template for planning and reporting on research in real clinical practice — RWE).Materials and methods.
S. L. Plavinskij, A. N. Barinova
doaj   +4 more sources

The effect of adding real-world evidence to regulatory submissions on the breadth of population indicated for rare disease medicine treatment by the European Medicines Agency

Journal of Pharmaceutical Policy and Practice, 2022
Background Despite calls for the use of additional real-world evidence (RWE) during drug development, rates of inclusion at the regulatory stage remain low.
Ravi Jandhyala
doaj   +1 more source

Editorial: Advancement of RWD/RWE utilization for enhancing drug development and benefit/risk assessment [PDF]

Frontiers in Pharmacology
Anick Berard, Berard Anick
exaly   +2 more sources

An updated cost-utility model for onasemnogene abeparvovec (Zolgensma®) in spinal muscular atrophy type 1 patients and comparison with evaluation by the Institute for Clinical and Effectiveness Review (ICER)

Journal of Market Access & Health Policy, 2021
Background: Recent cost-utility analysis (CUA) models for onasemnogene abeparvovec (Zolgensma®, formerly AVXS-101) in spinal muscular atrophy type 1 (SMA1) differ on key assumptions and results.
Rebecca Dean, Ivar Jensen, Phil Cyr, Beckley Miller, Benit Maru, Douglas M. Sproule, Douglas E. Feltner, Thomas Wiesner, Daniel C. Malone, Matthias Bischof, Walter Toro, Omar Dabbous   +11 more
doaj   +1 more source

Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model

Frontiers in Medicine, 2021
Real world evidence (RWE) and real-world data (RWD) are drawing ever-increasing attention in the pharmaceutical industry and drug regulatory authorities (DRAs) all over the world due to their paramount role in supporting drug development and regulatory ...
Meng Li, Shengqi Chen, Yunfeng Lai, Zuanji Liang, Jiaqi Wang, Junnan Shi, Haojie Lin, Dongning Yao, Hao Hu, Carolina Oi Lam Ung   +9 more
doaj   +1 more source

Brexu-cel RWE Statistical Analysis Plan [PDF]

, 2023
Statistical Analysis for Brexu-cel RWE ROCCA ...
Gregory Roloff
core   +2 more sources

Teaching Real-World Evidence: Protocol for a Systematic Review

JMIR Research Protocols, 2020
BackgroundReal-world evidence (RWE) refers to observational health care data beyond clinical trial data. It holds the promise of transforming health care as a new form of evidence to support decision makers in making decisions when developing and ...
Lam, Ching, van Velthoven, Michelle Helena, Chaudhury, Hassan, Meinert, Edward   +3 more
doaj   +1 more source

Using artificial intelligence to identify patients with migraine and associated symptoms and conditions within electronic health records

BMC Medical Informatics and Decision Making, 2023
Background Real-world evidence (RWE)—based on information obtained from sources such as electronic health records (EHRs), claims and billing databases, product and disease registries, and personal devices and health applications—is increasingly used to ...
Daniel Riskin, Roger Cady, Anand Shroff, Nada A. Hindiyeh, Timothy Smith, Steven Kymes   +5 more
doaj   +1 more source