Cargando…

Feasibility of Using Real-World Data to Replicate Clinical Trial Evidence

IMPORTANCE: Although randomized clinical trials are considered to be the criterion standard for generating clinical evidence, the use of real-world evidence to evaluate the efficacy and safety of medical interventions is gaining interest. Whether observational data can be used to address the same cl...

Descripción completa

Detalles Bibliográficos
Autores principales:	Bartlett, Victoria L., Dhruva, Sanket S., Shah, Nilay D., Ryan, Patrick, Ross, Joseph S.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	American Medical Association 2019
Materias:	Original Investigation
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6802419/ https://www.ncbi.nlm.nih.gov/pubmed/31596493 http://dx.doi.org/10.1001/jamanetworkopen.2019.12869

Ejemplares similares

Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval
por: Wallach, Joshua D., et al.
Publicado: (2021)

Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment
por: Wallach, Joshua D., et al.
Publicado: (2021)

Prostaglandin Coverage and Costs to Medicare and Medicare Beneficiaries, 2009-2017
por: Bartlett, Victoria L., et al.
Publicado: (2020)

Emulating the GRADE trial using real world data: retrospective comparative effectiveness study
por: Deng, Yihong, et al.
Publicado: (2022)

Trends in Within-Class Changes in US Average Wholesale Prices for Brand-Name Medications for Common Conditions From 2015 to 2020
por: Liu, Patrick, et al.
Publicado: (2021)

Feasibility of capturing real-world data from health information technology systems at multiple centers to assess cardiac ablation device outcomes: A fit-for-purpose informatics analysis report
por: Jiang, Guoqian, et al.
Publicado: (2021)

Physical activity, patient-reported symptoms, and clinical events: Insights into postprocedural recovery from personal digital devices
por: Bartlett, Victoria L., et al.
Publicado: (2021)

Age of Data at the Time of Publication of Contemporary Clinical Trials
por: Welsh, John, et al.
Publicado: (2018)

Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments
por: Skydel, Joshua J., et al.
Publicado: (2019)

Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators
por: Dhruva, Sanket S., et al.
Publicado: (2023)

Feasibility of using real-world data in the evaluation of cardiac ablation catheters: a test-case of the National Evaluation System for Health Technology Coordinating Center
por: Dhruva, Sanket S, et al.
Publicado: (2021)

Aggregating multiple real-world data sources using a patient-centered health-data-sharing platform
por: Dhruva, Sanket S., et al.
Publicado: (2020)

Use of Mechanical Cardiopulmonary Resuscitation Devices for Out-of-Hospital Cardiac Arrest, 2010-2016
por: Kahn, Peter A., et al.
Publicado: (2019)

Evolution of the American College of Cardiology and American Heart Association Cardiology Clinical Practice Guidelines: A 10‐Year Assessment
por: DuBose‐Briski, Victoria, et al.
Publicado: (2019)

Evidence supporting FDA approval and CMS national coverage determinations for novel medical products, 2005 through 2016: A cross-sectional study
por: Roginiel, Aliya C., et al.
Publicado: (2018)

Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock
por: Dhruva, Sanket S., et al.
Publicado: (2021)

Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017
por: Zhang, Audrey D., et al.
Publicado: (2020)

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)

Heart Watch Study: protocol for a pragmatic randomised controlled trial
por: Dhruva, Sanket S, et al.
Publicado: (2021)

Adherence with cardiovascular medications and the outcomes in patients with coronary arterial disease: “Real‐world” evidence
por: Chen, Chen, et al.
Publicado: (2022)

Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing
por: Fleischman, William, et al.
Publicado: (2019)

GLASS(Y) Half-Full: Moving Towards Greater Pragmatism in Outcome Ascertainment for Clinical Trials
por: Dhruva, Sanket S.
Publicado: (2021)

Real world data on cardiometabolic diseases in U.S. adults during the SARS-CoV-2 pandemic: a decentralized registry study
por: Shah, Parth, et al.
Publicado: (2022)

Assessment of Alectinib vs Ceritinib in ALK-Positive Non–Small Cell Lung Cancer in Phase 2 Trials and in Real-world Data
por: Wilkinson, Samantha, et al.
Publicado: (2021)

Editorial: Real-world data and real-world evidence in hematologic malignancies
por: Malagola, Michele, et al.
Publicado: (2023)

Increasing trust in real-world evidence through evaluation of observational data quality
por: Blacketer, Clair, et al.
Publicado: (2021)

Replication of Real-World Evidence in Oncology Using Electronic Health Record Data Extracted by Machine Learning
por: Benedum, Corey M., et al.
Publicado: (2023)

Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval
por: Shaw, Daniel L., et al.
Publicado: (2018)

Evidence of gene nucleotide composition favoring replication and growth in a fastidious plant pathogen
por: Castillo, Andreina I, et al.
Publicado: (2021)

Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019
por: Dhodapkar, Meera, et al.
Publicado: (2021)

Ablation of paroxysmal and persistent atrial fibrillation in the very elderly real‐world data on safety and efficacy
por: Willy, Kevin, et al.
Publicado: (2020)

The risk of sudden cardiac arrest and ventricular arrhythmia with rosiglitazone versus pioglitazone: real-world evidence on thiazolidinedione safety
por: Leonard, Charles E., et al.
Publicado: (2020)

Transposition of cardiovascular outcome trial effects to the real-world population of patients with type 2 diabetes
por: Sciannameo, V., et al.
Publicado: (2021)

Catheter-related complications and mortality of atrial fibrillation ablation following introduction of contact force-sensing technology
por: Akar, Joseph G, et al.
Publicado: (2020)

Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021
por: Gupta, Ravi, et al.
Publicado: (2022)

Proceed with Caution When Using Real World Data and Real World Evidence
por: Kim, Hun-Sung, et al.
Publicado: (2019)

4505 Implementation of Real-World Data and Real-World Evidence in Clinical Studies
por: Pham, Jessica, et al.
Publicado: (2020)

Genetic Evidence for Roles of Yeast Mitotic Cyclins at Single-Stranded Gaps Created by DNA Replication
por: Signon, Laurence
Publicado: (2017)

Somatic mutations inferred from RNA-seq data highlight the contribution of replication timing to mutation rate variation in a model plant
por: Staunton, Patrick M, et al.
Publicado: (2023)

Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study
por: Mooghali, Maryam, et al.
Publicado: (2023)

Cannot write session to /tmp/vufind_sessions/sess_agnkta6megrje4rl80dlms960a