The Use of Real-World Evidence and Data in Clinical Research and Postapproval Safety Studies-Reference-Cited by-同舟云学术

The Use of Real-World Evidence and Data in Clinical Research and Postapproval Safety Studies

Published:2018-11 Issue:6 Volume:52 Page:778-783
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Lamberti Mary Jo^ORCID,Kubick Wayne,Awatin Josephine,McCormick John,Carroll James,Getz Ken

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479018764662.pdf

Reference7 articles.

1. Uttam B, Anto V, Gowda A, et al. Evidence-based studies—their advantages and disadvantages in the data collection ecosystem. Insights in Biomed. 2016;1:1–5.

2. Support grows for wider use of real world evidence. http://www.pharmexec.com/support-grows-wider-use-real-world-evidence. Accessed September 21, 2017.

3. Real world evidence: FDA commits to advancing its use. http://www.raps.org/Regulatory-Focus/News/2017/09/19/28491/Real-World-Evidence-FDA-Commits-to-Advancing-its-Use/ Accessed September 20, 2017.

4. Sherman RE, Anderson SA, Dal Pan GJ, et al. Real world evidence—what is it and what can it tell us? N Engl J Med. 2016;375:2293–2297.

5. Integrated addendum to ICH E6(R1): Guideline for good clinical practice E6(R2). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4.pdf. Accessed August 15, 2017.

Cited by 20 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. Long-term Safety in Epstein–Barr Virus–Seropositive Kidney-only Transplant Recipients Treated With Belatacept in Clinical Practice: Final Study Results From the ENLiST Registry;Transplantation Direct;2024-05-17

2. Using Social Media as a Source of Real-World Data for Pharmaceutical Drug Development and Regulatory Decision Making;Drug Safety;2024-03-06

3. Opioids and Immunosuppression: Clinical Evidence, Mechanisms of Action, and Potential Therapies;Palliative Medicine Reports;2024-02-01

4. Políticas públicas de la gestión de almacenamiento de medicamentos en Hospitales públicos. Estudio de caso;Revista de Climatología;2023-08-20

5. Risk Management and Communication: Building Trust and Credibility With the Public;Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 2 : Safety Assessment Environmental Toxicologic Pathology;2023