Open Access<p>Synthetic and External Controls in Clinical Trials – A Primer for Researchers</p>
Author(s) -
Kristian Thorlund,
Louis Dron,
Jay Park,
Edward J. Mills
Publication year - 2020
Publication title -
clinical epidemiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.868
H-Index - 58
ISSN - 1179-1349
DOI - 10.2147/clep.s242097
Subject(s) - medicine , critical appraisal , control (management) , set (abstract data type) , key (lock) , computational biology , computer science , data science , alternative medicine , biology , pathology , artificial intelligence , programming language , computer security
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.