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

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...

Full description

Saved in:
Bibliographic Details
Published inClinical epidemiology Vol. 12; pp. 457 - 467
Main Authors Thorlund, Kristian, Dron, Louis, Park, Jay JH, Mills, Edward J
Format Journal Article
LanguageEnglish
Published New Zealand Dove Medical Press Limited 01.01.2020
Taylor & Francis Ltd
Dove
Dove Medical Press
Subjects
Alectinib
Cerliponase alfa
Clinical medicine
Clinical trials
Data collection
Datasets
Disease
Emtricitabine
Epidemiology
Evidence-based medicine
FDA approval
Intervention
Lung cancer
Medical research
Mutation
Palbociclib
Patients
Product development
rcts
real-world evidence
Researchers
Review
Statistical methods
synthetic control
Validity
Canada
RCTs
synthetic control
real-world evidence
Online AccessGet full text

Cover

More Information
Summary: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.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 14
ObjectType-Review-3
content type line 23
ISSN:1179-1349
1179-1349
DOI:10.2147/CLEP.S242097