Back to Journals » International Journal of Chronic Obstructive Pulmonary Disease » Volume 15

Comparing Randomized Controlled Trials and Real-World Studies in Chronic Obstructive Pulmonary Disease Pharmacotherapy

Authors Tashkin DP, Amin AN, Kerwin EM

Received 15 January 2020

Accepted for publication 3 May 2020

Published 2 June 2020 Volume 2020:15 Pages 1225—1243


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 4

Editor who approved publication: Dr Richard Russell

Supplementary video of "Comparing RCTs and Real-World Studies in COPD" [ID 244942].

Views: 244

Donald P Tashkin,1 Alpesh N Amin,2 Edward M Kerwin3

1The Division of Pulmonary and Critical Care Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA; 2Department of Medicine, School of Medicine University of California, Irvine, CA, USA; 3Crisor, LLC Clinical Research Institute of Southern Oregon, Medford, OR, USA

Correspondence: Donald P Tashkin
David Geffen School of Medicine, University of California, Los Angeles, CA 90095, USA
Tel +1 310 825 3163
Fax +1 310 206 5088

Abstract: Analytic epidemiological studies cover a large spectrum of study methodologies, ranging from noninterventional observational studies (population-based, case–control, or cohort studies) to interventional studies (clinical trials). Herein, we review the different research methodologies or study designs and discuss their advantages and disadvantages in the context of chronic obstructive pulmonary disease (COPD) pharmacotherapy. Although randomized controlled trials (RCTs) are considered the “gold standard” for evaluating the efficacy and safety of an intervention, observational studies conducted in a real-world scenario are useful in providing evidence on the effectiveness of the intervention in clinical practice; understanding both efficacy and effectiveness is important from the clinician’s perspective. Pragmatic clinical trials that use real-world data while retaining randomization bridge the gap between explanatory RCTs and noninterventional observational studies. Overall, different study designs have their associated advantages and disadvantages; together, findings from all types of studies bring about progress in clinical research as elucidated through examples from COPD research in this paper.

Keywords: clinical trials, COPD, pharmacotherapy, study designs

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at 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]