Back to Journals » Journal of Multidisciplinary Healthcare » Volume 11

Real world data: an opportunity to supplement existing evidence for the use of long-established medicines in health care decision making

Authors Katkade VB, Sanders KN, Zou KH

Received 16 December 2017

Accepted for publication 21 March 2018

Published 2 July 2018 Volume 2018:11 Pages 295—304

DOI https://doi.org/10.2147/JMDH.S160029

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Cristina Weinberg

Peer reviewer comments 3

Editor who approved publication: Dr Scott Fraser


Vaibhav B Katkade, Kafi N Sanders, Kelly H Zou

Pfizer Inc, New York, NY, USA

Abstract: Evidence from medication use in the real world setting can help to extrapolate and/or augment data obtained in randomized controlled trials and establishes a broad picture of a medication’s place in everyday clinical practice. By supplementing and complementing safety and efficacy data obtained in a narrowly defined (and often optimized) patient population in the clinical trial setting, real world evidence (RWE) may provide stakeholders with valuable information about the safety and effectiveness of a medication in large, heterogeneous populations. RWE is emerging as a credible information source; however, there is scope for enhancements to real world data (RWD) sources by understanding their complexities and applying the most appropriate analytical tools in order to extract relevant information. In addition to providing information for clinicians, RWE has the potential to meet the burden of evidence for regulatory considerations and may be used in approval of new indications for medications. Further understanding of RWD collection and analysis is needed if RWE is to achieve its full potential.

Keywords: electronic health records, evidence-based medicine, real world data, real world evidence, randomized controlled trial

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]