Report on the current status of the use of real‐world data (RWD) and real‐world evidence (RWE) in drug development and regulation-Reference-Cited by-同舟云学术

Report on the current status of the use of real‐world data (RWD) and real‐world evidence (RWE) in drug development and regulation

Published:2019-07-10 Issue:9 Volume:85 Page:1874-1877
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Breckenridge Alasdair M.¹,Breckenridge Ross A.²,Peck Carl C.³⁴

Affiliation:

1. Clinical Pharmacology, Department of Pharmacology and TherapeuticsUniversity of Liverpool Liverpool UK

2. ARJUNA Therapeutics, C/ XESTA №78‐A2, PARQUE EMPRESARIAL NOVO MILLADOIRO – 15895 MILLADOIRO, A CORUÑA Spain

3. Department of Bioengineering and Therapeutic SciencesUniversity of California at San Francisco San Francisco CA USA

4. NDA Partners, LLC Rochelle VA USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.14026

Reference17 articles.

1. Data Rich, Information Poor: Can We Use Electronic Health Records to Create a Learning Healthcare System for Pharmaceuticals?

2. U.S. Food and Drug Administration.Framework for FDA's Real‐World Evidence Program.December 2018.https://www.fda.gov/media/120060/download. Accessed 1 July 2019.

3. Improving therapeutic effectiveness and safety through big healthcare data

4. Accelerated approval of medicines: fit for purpose?

5. RawlinsM.De Testimonio: Harveian lecture of Royal College of Physicians. London2008.https://www.kcl.ac.uk/lsm/study/pgofferholders/docs/Mike-Rawlins-Harvian-lecture.pdf. Accessed 1 July 2019.

Cited by 24 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. Expanding the use of real‐world data through the development of user‐friendly tools to support drug development: Example of an organ impairment dashboard;Pharmacology Research & Perspectives;2024-07-21

2. Psychostimulants and social behaviors;Frontiers in Pharmacology;2024-04-25

3. The Amager Project IV: suicidal behavior and aftercare: real world data (RWD) from a prospective observational project;Nordic Journal of Psychiatry;2024-02-10

4. Next-generation study databases require FAIR, EHR-integrated, and scalable Electronic Data Capture for medical documentation and decision support;npj Digital Medicine;2024-01-12

5. The value of using real-world evidence as a source of clinical evidence in the European medical device regulations: a mixed methods study;Expert Review of Medical Devices;2023-12-05