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Synthetic and External Controls in Clinical Trials – A Primer for Researchers

Authors Thorlund K, Dron L, Park JJH, Mills EJ

Received 12 December 2019

Accepted for publication 21 April 2020

Published 8 May 2020 Volume 2020:12 Pages 457—467

DOI https://doi.org/10.2147/CLEP.S242097

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Professor Irene Petersen


Kristian Thorlund,1,2 Louis Dron,2 Jay JH Park,2,3 Edward J Mills1,2

1Department of Health Research Methods, Evidence & Impact (HEI), McMaster University, Hamilton, ON, Canada; 2MTEK Sciences, Vancouver, BC, Canada; 3Department of Medicine, University of British Columbia, Vancouver, BC, Canada

Correspondence: Kristian Thorlund
MTEK Sciences, 802-777 West Broadway, Vancouver, BC V5Z 1J5, Canada
Email thorluk@mcmaster.ca

Abstract: There has been a rapid expansion in the use of non-randomized evidence in the regulatory approval of treatments globally. An emerging set of methodologies have been utilized to provide greater insight into external control data used for these purposes, collectively known as synthetic control methods. Through this paper, we provide the reader with a set of key questions to help assess the quality of literature publications utilizing synthetic control methodologies. Common challenges and real-life examples of synthetic controls are provided throughout, alongside a critical appraisal framework with which to assess future publications.

Keywords: synthetic control, RCTs, real-world evidence

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