Results 21 to 30 of about 2,242,374 (316)

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

British medical journal, 2021
In alignment with the International Council of Harmonization’s strategic goals, a public-private consortium has developed a structured template for planning and reporting on the implementation of real world evidence (RWE) studies of the safety and ...
Shirley V. Wang, Simone P. Pinheiro, Wei Hua, P. Arlett, Y. Uyama, J. Berlin, D. Bartels, K. Kahler, Lily G. Bessette, S. Schneeweiss   +9 more
semanticscholar   +1 more source

Real-World Evidence Analysis of a Hybrid Closed-Loop System

Journal of Diabetes Science and Technology, 2023
Background: We analyzed real-world evidence to assess the performance of the mylife CamAPS FX hybrid closed-loop system. Methods: Users from 15 countries across different age groups who used the system between May 9, 2022, and December 3, 2022, and who ...
Heba Alwan, M. Wilinska, Y. Ruan, Julien da Silva, R. Hovorka   +4 more
semanticscholar   +1 more source

Effectiveness and safety of recombinant zoster vaccine: A review of real-world evidence

Human Vaccines & Immunotherapeutics, 2023
The recombinant zoster vaccine (RZV) was licensed in the US for prevention of herpes zoster (HZ) in 2017. We conducted a literature search (January 1, 2017–August 1, 2023) using PubMed, Embase, and Scopus to consolidate the real-world evidence related to
Raunak Parikh, David Singer, Elizabeth Chmielewski-Yee, Christophe Dessart   +3 more
semanticscholar   +1 more source

Disparities in healthcare providers’ interpretations and implementations of ACIP’s meningococcal vaccine recommendations

Human Vaccines & Immunotherapeutics, 2020
Invasive meningococcal disease (IMD) caused by the bacteria Neisseria meningitidis is rare but potentially fatal. For healthy adolescents, the US Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination with MenACWY and ...
Liping Huang, Amir Goren, Lulu K. Lee, Vicky W. Li, Amanda Dempsey, Amit Srivastava   +5 more
doaj   +1 more source

Strategies to Address Current Challenges in Real-World Evidence Generation in Japan

Drugs - Real World Outcomes, 2023
The generation of real-world evidence (RWE), which describes patient characteristics or treatment patterns using real-world data (RWD), is rapidly growing more popular as a tool for decision-making in Japan.
Thomas Laurent, Dimitra Lambrelli, Ryozo Wakabayashi, Takahiro Hirano, Ryohei Kuwatsuru   +4 more
doaj   +1 more source

Real‐world evidence in hepatocellular carcinoma [PDF]

Liver International, 2021
AbstractReal‐world evidence includes all health‐related information, such as electronic health records, insurance claims, pharmacy records and wearables that are obtained outside of clinical trials. These data can provide critical insights into the natural history of disease and evaluate the safety and effectiveness of treatment regimens used in ...
Andrea R, Mospan, Heather L, Morris, Michael W, Fried   +2 more
openaire   +2 more sources

The Role of Real‐World Evidence in FDA‐Approved New Drug and Biologics License Applications

Clinical pharmacology and therapy, 2021
The US Food and Drug Administration (FDA) is open to accepting real‐world evidence (RWE) to support its assessment of medical products. However, RWE stakeholders lack a shared understanding of FDA’s evidentiary expectations for the use of RWE in ...
C. Purpura, E. Garry, N. Honig, A. Case, J. Rassen   +4 more
semanticscholar   +1 more source

Real-world evidence for regulatory decision-making: updated guidance from around the world

Frontiers in Medicine, 2023
Leveraging the value of real-world evidence (RWE) to make informed regulatory decisions in the field of health care continues to gain momentum. Improving clinical evidence generation by evaluating the outcomes and patient experiences at the point-of-care
L. Burns, N. Le Roux, Robert Kalesnik-Orszulak, Jennifer Christian, Jennifer Dudinak, Frank Rockhold, S. Khozin, J. O’Donnell   +7 more
semanticscholar   +1 more source

HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real‐world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force

Pharmacoepidemiology and Drug Safety, 2022
Ambiguity in communication of key study parameters limits the utility of real‐world evidence (RWE) studies in healthcare decision‐making. Clear communication about data provenance, design, analysis, and implementation is needed.
Shirley V. Wang, A. Pottegård, William Crown, P. Arlett, D. Ashcroft, E. Benchimol, M. Berger, G. Crane, W. Goettsch, Wei Hua, S. Kabadi, D. Kern, X. Kurz, S. Langan, Takahiro Nonaka, L. Orsini, S. Perez-Gutthann, Simone Pinheiro, N. Pratt, S. Schneeweiss, M. Toussi, Rebecca J Williams   +21 more
semanticscholar   +1 more source

Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions

Nature Communications, 2022
Studies that generate real-world evidence on the effects of medical products through analysis of digital data collected in clinical practice provide key insights for regulators, payers, and other healthcare decision-makers.
Shirley V. Wang, S. K. Sreedhara, S. Schneeweiss, Jessica M. Joshua J. Krista F. Elisabetta Yinzhu Moa Mufad Franklin Gagne Huybrechts Patorno Jin Lee Mahesri , J. Franklin, J. Gagne, K. Huybrechts, Elisabetta Patorno, Yinzhu Jin, Moa P. Lee, M. Mahesri, Ajinkya M Pawar, Julie Barberio, Lily G. Bessette, Kristyn Chin, N. Gautam, A. S. Ortiz, Ellen Sears, K. Stefanini, Mimi Zakarian, Sara Z Dejene, James R. Rogers, Gregory Brill, J. Landon, J. Lii, T. Tsacogianis, S. Vine, E. Garry, Liz Gibbs, Monica Gierada, D. Isaman, E. Payne, S. Alwardt, P. Arlett, D. Bartels, A. Bate, J. Berlin, A. Bourke, B. Bradbury, Jeffrey S. Brown, K. Burnett, T. Brennan, K. Chan, N. Choi, F. de Vries, H. Eichler, K. Filion, Lisa Freeman, J. Hallas, L. Happe, Sean Hennessy, P. Jónsson, J. Ioannidis, J. Jiménez, K. Kahler, C. Laine, E. Loder, A. Makady, David Martin, Michael D. Nguyen, B. Nosek, Richard Platt, Robert W. Platt, J. Seeger, W. Shrank, L. Smeeth, Henrik Toft Sørensen, P. Tugwell, Y. Uyama, R. Willke, W. Winkelmayer, D. Zarin   +71 more
semanticscholar   +1 more source