Results 1 to 10 of about 5,649 (188)

Real world evidence (RWE) - Are we (RWE) ready?

Perspectives in Clinical Research, 2018
Real world evidence is important as it complements data from randomised controlled trials (RCTs). Both have limitations in design, interpretation, and extrapolatability.
Viraj Ramesh Suvarna
doaj   +3 more sources

The unregulated majority: who ensures quality in non-submission real-world studies? [PDF]

Frontiers in Medicine
Real-world evidence (RWE) plays an increasingly important role in healthcare decision-making, yet most industry-sponsored RWE studies are not intended for regulatory or reimbursement submission.
Alexandros Sagkriotis, Alexandros Sagkriotis   +1 more
doaj   +2 more sources

Advancing real-world evidence in Brazil: regulatory gaps and global lessons [PDF]

The Lancet Regional Health. Americas
Summary: Regulatory agencies are increasingly incorporating real-world data (RWD) and real-world evidence (RWE) into decision-making frameworks to complement randomized clinical trials. While some regions, such as the U.S.
Nélio Cézar de Aquino, Cadiele Oliana Reichert, Luis Alberto de Padua Covas Lage, Hebert Fabricio Culler, Felipe Santa Rosa Roitberg, Vanderson Rocha, Flávia Neves Rocha Alves, Juliana Pereira   +7 more
doaj   +2 more sources

The burden of hospitalisations for COVID-19 in France: a study of all cases in the national insurance claims database in 2020

Journal of Market Access & Health Policy, 2023
Background The economic consequences of the recent COVID-19 pandemic were substantial. However, direct medical costs in France have not been determined.Objective To describe patient characteristics, intensity of care, mortality, and direct medical costs ...
Claire Leboucher, Cécile Blein, Valérie Machuron, Kelly Benyounes, Katell Le lay, Aurélie Millier, Romain Supiot, François Raffi   +7 more
doaj   +1 more source

Health Canada Usage of Real World Evidence (RWE) in Regulatory Decision Making compared with FDA/EMA usage based on publicly available information

Journal of Pharmacy & Pharmaceutical Sciences, 2022
Purpose: Between January 2020 and December 2021, Health Canada provided a Summary Basis of Decision (SBD) for each of 110 products approved, including 29 oncology products and 21 non-oncology orphan drugs.
Catherine Lau, Fakhreddin Jamali, Raimar Loebenberg   +2 more
doaj   +1 more source

How can real‐world evidence aid decision making during the life cycle of nonprescription medicines?

Clinical and Translational Science, 2022
Real‐world evidence (RWE) is an emerging scientific discipline which is being increasingly utilized for decision making on prescription‐only medicines.
Emese Csoke, Sabine Landes, Matthew J. Francis, Larry Ma, Denise Teotico Pohlhaus, Christelle Anquez‐Traxler   +5 more
doaj   +1 more source

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

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

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

Methods for the inclusion of real-world evidence in network meta-analysis

BMC Medical Research Methodology, 2021
Background Network Meta-Analysis (NMA) is a key component of submissions to reimbursement agencies world-wide, especially when there is limited direct head-to-head evidence for multiple technologies from randomised controlled trials (RCTs).
David A. Jenkins, Humaira Hussein, Reynaldo Martina, Pascale Dequen-O’Byrne, Keith R. Abrams, Sylwia Bujkiewicz   +5 more
doaj   +1 more source