Cargando…

Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality

The role of real‐world evidence (RWE) in regulatory, drug development, and healthcare decision‐making is rapidly expanding. Recent advances have increased the complexity of cancer care and widened the gap between randomized clinical trial (RCT) results and the evidence needed for real‐world clinical...

Descripción completa

Detalles Bibliográficos
Autores principales:	Miksad, Rebecca A., Abernethy, Amy P.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2017
Materias:	Development
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5814721/ https://www.ncbi.nlm.nih.gov/pubmed/29214638 http://dx.doi.org/10.1002/cpt.946

Ejemplares similares

Small But Mighty: The Use of Real‐World Evidence to Inform Precision Medicine
por: Miksad, Rebecca A., et al.
Publicado: (2019)

Real world evidence (RWE) - Are we (RWE) ready?
por: Suvarna, Viraj Ramesh
Publicado: (2018)

Real-world evidence (RWE): A challenge for regulatory agencies discussion of the RWE conference with the network of the european medicine agencies, patients, and experts
por: Maison, Patrick, et al.
Publicado: (2022)

Real world evidence (RWE) – a disruptive innovation or the quiet evolution of medical evidence generation?
por: Khosla, Sajan, et al.
Publicado: (2018)

Paving the way for patient centricity in real-world evidence (RWE): Qualitative interviews to identify considerations for wider implementation of patient-reported outcomes in RWE generation
por: Maruszczyk, Konrad, et al.
Publicado: (2023)

RWE Framework: An Interactive Visual Tool to Support a Real-World Evidence Study Design
por: Xia, Andrew D., et al.
Publicado: (2019)

STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies
por: Wang, Shirley V, et al.
Publicado: (2021)

Developing a multi-center clinical data mart of ACEI and ARB for real-world evidence (RWE)
por: Kim, Hun-Sung, et al.
Publicado: (2018)

Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World
por: McNair, Douglas, et al.
Publicado: (2021)

Mapping Canadian Data Assets to Generate Real-World Evidence: Lessons Learned from Canadian Real-World Evidence for Value of Cancer Drugs (CanREValue) Collaboration’s RWE Data Working Group
por: Dai, Wei Fang, et al.
Publicado: (2022)

Harnessing Real-World Evidence to Advance Cancer Research
por: Tang, Monica, et al.
Publicado: (2023)

Assessment of the real-world impact of the Thai smoking cessation programme on clinical outcomes: protocol for a multicentre prospective observational study
por: Chaisai, Chayutthaphong, et al.
Publicado: (2022)

Awareness, Knowledge, and Utility of RCT Data vs RWE: Results From a Survey of US Cardiologists: Real-world Evidence in Clinical Decision Making
por: Villines, Todd C, et al.
Publicado: (2020)

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

Treatment Outcomes of High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) in Real-World Evidence (RWE) Studies: Systematic Literature Review (SLR)
por: Musat, Mihaela Georgiana, et al.
Publicado: (2022)

PCR103 A Digitally Enabled Care and Real World Evidence (RWE) Research Program Among Individuals with Asthma and COPD during the COVID-19 Pandemic
por: Willmon, R, et al.
Publicado: (2022)

Ensuring radiation safety inside SPS
Publicado: (1977)

CHALLENGES RELATED TO DATA SOURCES FOR RWE IN AGING RESEARCH
por: Lu, Kevin
Publicado: (2022)

Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan
por: Nishioka, Kinue, et al.
Publicado: (2021)

Effectiveness and safety of dapagliflozin in real-life patients: data from the DAPA-RWE Spanish multicentre study
por: Morales, Cristóbal, et al.
Publicado: (2022)

Bridging the Gap Between RCTs and RWE Through Endpoint Selection
por: LoCasale, Robert J., et al.
Publicado: (2020)

‘It’s like trying to ice a cake that’s not been baked’: a qualitative exploration of the contextual factors associated with implementing an evidence-based information intervention for family carers at the end of life
por: Mathieson, Amy, et al.
Publicado: (2020)

Legal reflections on the evolving role of general practitioners in China’s primary care: an assessment of regulatory strategies
por: Liu, Ziyu, et al.
Publicado: (2018)

Cancer Moonshot Data and Technology Team: Enabling a National Learning Healthcare System for Cancer to Unleash the Power of Data
por: Hsu, ER, et al.
Publicado: (2017)

Validation of the howRu and howRwe questionnaires at the individual patient level
por: Hendriks, Steven H., et al.
Publicado: (2015)

Imputing Biomarker Status from RWE Datasets—A Comparative Study
por: Traynor, Carlos, et al.
Publicado: (2021)

Connected health for growth hormone treatment research and clinical practice: learnings from different sources of real-world evidence (RWE)—large electronically collected datasets, surveillance studies and individual patients’ cases
por: Boman, Nea, et al.
Publicado: (2021)

Analysis of evidence appraisals for interventional studies in family medicine using an informatics approach
por: Sahin, Alain Nathan, et al.
Publicado: (2019)

The World Heart Observatory: Harnessing the Power of Data for Cardiovascular Health
por: Perel, Pablo, et al.
Publicado: (2022)

Real‐world progression, treatment, and survival outcomes during rapid adoption of immunotherapy for advanced non–small cell lung cancer
por: Khozin, Sean, et al.
Publicado: (2019)

Substance misuse in later life: challenges for primary care: a review of policy and evidence
por: Rao, Rahul, et al.
Publicado: (2019)

4235 The Use of Checklists Throughout the Lifecourse of a Clinical Research Study: The Rockefeller University Checklist Suite
por: Brassil, Donna, et al.
Publicado: (2020)

A short generic patient experience questionnaire: howRwe development and validation
por: Benson, Tim, et al.
Publicado: (2014)

Using RWE research to extend clinical trials in diabetes: An example with implications for the future
por: Seeger, John D., et al.
Publicado: (2020)

USE OF RWD TO GENERATE RWE IN THE ALZHEIMER'S DISEASE SETTING: CHALLENGES AND FUTURE DIRECTIONS
por: DiBello, Julia
Publicado: (2022)

Burden of Illness in Follicular Lymphoma with Multiple Lines of Treatment, Italian RWE Analysis
por: Ferreri, Andrés J. M., et al.
Publicado: (2023)

Harnessing the power of the Grid
Publicado: (2009)

Real world evidence in cardiovascular medicine: ensuring data validity in electronic health record-based studies
por: Hernandez-Boussard, Tina, et al.
Publicado: (2019)

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)

Cannot write session to /tmp/vufind_sessions/sess_v9759qfelfevt58s71g8k7d4c6