Considerations in characterizing real‐world data relevance and quality for regulatory purposes: A commentary-Reference-Cited by-同舟云学术

Considerations in characterizing real‐world data relevance and quality for regulatory purposes: A commentary

Published:2018-12-05 Issue:4 Volume:28 Page:439-442
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Girman Cynthia J.¹^ORCID,Ritchey Mary E.²^ORCID,Zhou Wei³,Dreyer Nancy A.⁴^ORCID

Affiliation:

1. Patient‐reported Outcomes and Real‐world EvidenceCERobs Consulting, LLC Chapel Hill North Carolina

2. Epidemiology, Medical Devices, and Real‐World EvidenceRTI—Health Solutions, Research Triangle Park Durham North Carolina

3. Department of Pharmacoepidemiology, Center for Observational and Real‐world EvidenceMerck & Co., Inc North Wales Pennsylvania

4. Real‐World & Analytic SolutionsIQVIA Cambridge Massachusetts

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.4697

Reference15 articles.

1. Energy and Commerce Committee.21stCentury Cures Act. Retrieved 01OCT 2018https://energycommerce.house.gov/cures

2. Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0

3. Center for drug evaluation and research. Prescription Drug User Fee Act (PDUFA)—PDUFA VI: fiscal years 2018–2022. U.S. Food and Drug Administration. Retrieved 01 October 2018.http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm446608.htm

4. U.S. Food and Drug Administration.Use of real‐world evidence to support regulatory decision‐making for medical devices. Guidance for Industry and Food and Drug Administration staff. Center for Devices and Radiological Health (CDRH). Retrieved 12 October 2018.https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm513027.pdf

5. Berger M Daniel G Frank K et al.A framework for regulatory use of real world evidence. Retrieved 06SEPT2017.https://healthpolicy.duke.edu/sites/default/files/atoms/files/rwe_white_paper_2017.09.06.pdf

Cited by 27 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Novel Design and Analysis for Rare Disease Drug Development;Mathematics;2024-02-21

2. Model-based standardization using multiple imputation;BMC Medical Research Methodology;2024-02-10

3. ATRAcTR (Authentic Transparent Relevant Accurate Track-Record): a screening tool to assess the potential for real-world data sources to support creation of credible real-world evidence for regulatory decision-making;Health Services and Outcomes Research Methodology;2023-11-29

4. Innovative thinking of clinical investigation for rare disease drug development;Orphanet Journal of Rare Diseases;2023-09-22

5. ATRAcTR (Authentic Transparent Relevant Accurate Track-Record): A Screening Tool to Assess the Potential for Real-World Data Sources to Support Creation of Credible Real-World Evidence for Regulatory Decision-Making;2023-06-07