Review of real-world data study-Reference-Cited by-同舟云学术

Review of real-world data study

Published:2021-04-24 Issue:1 Volume:20 Page:56-63
ISSN:2618-8473
Container-title:Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice
language:
Short-container-title:GCP

Author:

Goldina T. A.¹^ORCID,Kolbin A. S.²^ORCID,Belousov D. Yu.³^ORCID,Borovskaya V. G.²

Affiliation:

1. Sanofi-Aventis Group JSC

2. First Saint Petersburg State Medical University named after I.I. acad. I.P. Pavlov

3. LLC «Center for Pharmacoeconomic Research»

Abstract

The article defines the terms «real-world data» (RWD) and «real-world evidence» (RWE); classification of RWD, advantages, disadvantages and their overcoming are outlined; provides a description of the purpose of collecting RWD.

Publisher

Publishing House OKI

Subject

General Medicine

Reference11 articles.

1. Darrow JJ, Avorn J, Kesselheim AS. FDA Approval and Regulation of Pharmaceuticals, 1983-2018. JAMA. 2020;323(2):164-176. DOI: 10.1001/jama.2019.20288

2. Martsevich S.Yu., Kutishenko N.P. Randomizirovannye klinicheskie issledovaniya i nablyudatel'nye issledovaniya: sootnoshenie v ierarkhii dokazatel'stv effektivnosti lekarstv // Ratsional'naya Farmakoterapiya v Kardiologii. 2016;12(5):567-573. [Martsevich SYu, Kutishenko NP. Randomised Clinical Trials and Observational Studies: the Ratio in the Hierarchy of Evidence of the Efficacy of Drugs. Rational Pharmacotherapy in Cardiology. 2016;12(5):567-573. (In Russ).] DOI: 10.20996/1819-6446-2016-12-5-567-573

3. Issledovaniya real'noi klinicheskoi praktiki / Pod red. A.S. Kolbina — M.: Izdatel'stvo OKI: Buki Vedi, 2020. — 208 s.: il. ISBN 978-5- 4465-2902-5. [Issledovaniya real’noj klinicheskoj praktiki / Ed by AS Kolbin. Moscow: Publishing OKI: Buki Vedi, 2020. (In Russ).] Dostupno po: https://clck.ru/QkeeP

4. Martsevich S.Yu., Lukina Yu.V., Kutishenko N.P. Eshche raz ob ierarkhii dokazatel'stv v meditsine, ili mozhno li s pomoshch'yu nablyudatel'nykh issledovanii reshit' vopros o vybore naibolee effektivnogo i bezopasnogo preparata // Ratsional'naya Farmakoterapiya v Kardiologii. 2017;13(2):270-274. [Martsevich SYu, Lukina YuV, Kutishenko NP. Once again about the Hierarchy of Evidences in Medicine or whether it is Possible to Choose the Most Effective and Safe Drug with the Help of Observational Studies. Rational Pharmacotherapy in Cardiology. 2017;13(2):270-274. (In Russ).] DOI: 10.20996/1819-6446-2017-13-2-270-274

5. Framework for FDA’s Real-World Evidence Program. December 2018. Rezhim dostupa: https://www.fda.gov/media/120060/download.

Cited by 9 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. Background of use in real clinical practice of the results of a systematic review and meta-analysis by comparison vacuum-assisted laparostomy and other options of multi-stage surgical treatment of urgent abdominal pathology and abdominal injuries;Journal of Volgograd State Medical University;2024-08-05

2. Modern methodological approaches to comparative real-world studies using the analysis of botulotoxin A drugs for treating spasticity syndrome in children with cerebral palsy;Patient-Oriented Medicine and Pharmacy;2024-05-22

3. Data and Evidence of Real Clinical Practice: A Comparative Legal Study;Actual Problems of Russian Law;2024-02-16

4. Real-World Clinical and Economic Efficacy of Succinate-Based Therapy with Remaxol of Alcohol Hepatitis;The Russian Archives of Internal Medicine;2024-02-12

5. The use of ribociclib in real clinical practice: results of a single-center observational retrospective study;Meditsinskiy sovet = Medical Council;2024-01-17