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

• Published in: Clinical epidemiology Vol. 12; pp. 457 - 467
• Main Authors: Thorlund, Kristian, Dron, Louis, Park, Jay JH, Mills, Edward J
• Format: Journal Article
• Language: English
• 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

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...