Cargando…

Real World-Evidence for Regulatory Use Decision Aid: An Interactive Tool To Inform Clinical Development and Regulatory Strategies

Real-world evidence (RWE) is increasingly used to complement clinical trial data for regulatory decision-making and in certain cases utilized to establish the clinical effectiveness of a therapy. However, the use of RWE is not applicable for all regulatory submissions, and it can be challenging to i...

Descripción completa

Detalles Bibliográficos
Autores principales:	Burns, Leah, Kalesnik-Orszulak, Robert, Spring, Rick, Zeegers, Fabienne, Rutstein, Mark, Hukkelhoven, Mathias, Wruck, Lisa, O’Donnell, John
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer Healthcare 2022
Materias:	Original Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9379219/ https://www.ncbi.nlm.nih.gov/pubmed/35972721 http://dx.doi.org/10.1007/s12325-022-02257-4

Ejemplares similares

Real-world evidence for regulatory decision-making: updated guidance from around the world
por: Burns, Leah, et al.
Publicado: (2023)

Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe
por: Cave, Alison, et al.
Publicado: (2019)

Contribution of Real‐World Evidence in European Medicines Agency's Regulatory Decision Making
por: Bakker, Elisabeth, et al.
Publicado: (2022)

Regulatory Approval With Real-World Data From Regulatory Science Perspective in Japan
por: Maeda, Hideki, et al.
Publicado: (2022)

Real‐world evidence to support regulatory decision‐making for medicines: Considerations for external control arms
por: Burcu, Mehmet, et al.
Publicado: (2020)

Transferability of real-world data across borders for regulatory and health technology assessment decision-making
por: Jaksa, Ashley, et al.
Publicado: (2022)

Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions
por: Li, Pei, et al.
Publicado: (2023)

EU-funded initiatives for real world evidence: descriptive analysis of their characteristics and relevance for regulatory decision-making
por: Plueschke, Kelly, et al.
Publicado: (2018)

Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions
por: Wang, Shirley V., et al.
Publicado: (2022)

Modernizing Regulatory Evidence with Trials and Real-World Studies
por: Dreyer, Nancy A., et al.
Publicado: (2020)

Examining the Use of Real‐World Evidence in the Regulatory Process
por: Beaulieu‐Jones, Brett K., et al.
Publicado: (2019)

The Current Landscape and Emerging Applications for Real‐World Data in Diagnostics and Clinical Decision Support and its Impact on Regulatory Decision Making
por: Baumfeld Andre, Elodie, et al.
Publicado: (2022)

Real-World and Regulatory Perspectives of Artificial Intelligence in Cardiovascular Imaging
por: Wellnhofer, Ernst
Publicado: (2022)

Using real-world data for supporting regulatory decision making: Comparison of cardiovascular and safety outcomes of an empagliflozin randomized clinical trial versus real-world data
por: Jang, Ha Young, et al.
Publicado: (2022)

Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable
por: Dreyer, Nancy A.
Publicado: (2018)

Harnessing Real-World Data for Regulatory Use and Applying Innovative Applications
por: Zou, Kelly H, et al.
Publicado: (2020)

A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real‐World Evidence for Regulatory Decisions
por: Gatto, Nicolle M., et al.
Publicado: (2019)

Regulatory T cells hasten infant AIDS
por: Bashyam, Hema
Publicado: (2007)

Editorial: The use of real world data for regulatory purposes in the rare diseases setting
por: Giannuzzi, Viviana, et al.
Publicado: (2022)

USING REAL-WORLD EVIDENCE TO SUPPORT THE FDA REGULATORY APPROVAL: METHODOLOGICAL CONSIDERATIONS
por: Lu, Kevin, et al.
Publicado: (2022)

Real‐world data: Assessing electronic health records and medical claims data to support regulatory decision‐making for drug and biological products
por: Girman, Cynthia J., et al.
Publicado: (2022)

T regulatory cells: aid or hindrance in the clearance of disease?
por: Coleman, Clint A, et al.
Publicado: (2007)

Decisions by regulatory agencies: are they evidence-based?
por: Furberg, Curt D
Publicado: (2007)

The Role of Real-World Evidence in Treatment Decision-Making, Regulatory Assessment, and Understanding the Perspectives of People with Type 2 Diabetes: Examples with Gliclazide MR
por: Khunti, Kamlesh, et al.
Publicado: (2023)

Considerations in characterizing real‐world data relevance and quality for regulatory purposes: A commentary
por: Girman, Cynthia J., et al.
Publicado: (2018)

Trial designs using real‐world data: The changing landscape of the regulatory approval process
por: Baumfeld Andre, Elodie, et al.
Publicado: (2019)

Race and Ethnicity in Real-World Data Sources: Considerations for Medical Device Regulatory Efforts
por: Tarver, Michelle E.
Publicado: (2021)

Organic Dissemination and Real-World Implementation of Patient Decision Aids for Left Ventricular Assist Device
por: Thompson, Jocelyn S., et al.
Publicado: (2018)

Regulatory T Cells in Infection
por: Maizels, Rick M., et al.
Publicado: (2011)

Footprint-free human fetal foreskin derived iPSCs: A tool for modeling hepatogenesis associated gene regulatory networks
por: Matz, Peggy, et al.
Publicado: (2017)

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
por: Li, Meng, et al.
Publicado: (2021)

Unveiling Angiotensin II and Losartan-Induced Gene Regulatory Networks Using Human Urine-Derived Podocytes
por: Thimm, Chantelle, et al.
Publicado: (2023)

Regulatory features aid interpretation of 3’UTR Variants
por: Romo, Lindsay, et al.
Publicado: (2023)

Discussion of Race and Ethnicity in Real-World Data Sources: Considerations for Medical Device Regulatory Efforts
por: Hamidian Jahromi, Alireza, et al.
Publicado: (2021)

How can real‐world evidence aid decision making during the life cycle of nonprescription medicines?
por: Csoke, Emese, et al.
Publicado: (2021)

Use of real-world evidence to support regulatory decisions on medical devices in China and a unique opportunity to gain accelerated approval in “Boao Lecheng Pilot Zone”
por: Li, Jiahe, et al.
Publicado: (2023)

Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality
por: Miksad, Rebecca A., et al.
Publicado: (2017)

Of mice and men: phylogenetic footprinting aids the discovery of regulatory elements
por: Zhang, Zhaolei, et al.
Publicado: (2003)

Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation
por: Yu, Yue, et al.
Publicado: (2023)

The changing role of animal toxicology in support of regulatory decisions.
por: Miller, F J, et al.
Publicado: (1983)

Cannot write session to /tmp/vufind_sessions/sess_gcgc1rk78kdfed08l3fhqk105e