Single-arm trials, unlike placebo-controlled randomized control trials, forgo the use of a placebo or standard-of-care as a control and establish clinical benefit by demonstrating the effects of a new therapy or treatment via comparison with a synthetic control arm (SCA) derived from external sources. This alternative approach leverages real-world data from various sources or evaluations of historical trial data for the sake of comparison. The use of SCA has enabled investigators to leverage combined data from uncontrolled single-arm trials and post-market studies to create much smaller trials.
Our newly updated eBook, “Demystifying Synthetic Control Arms,” delves into this topic and covers:
- An introduction to synthetic control arms
- Propensity scoring methods
- Bayesian dynamic borrowing
- A case study on non-small cell lung cancer
- Questions to ask if you are considering a choice between placebo-controlled and single-arm trials
To download the complimentary eBook, click below:
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Read more from Perspectives on Enquiry and Evidence:
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FDA Guidance on the Design and Conduct of Externally Controlled Trials — What to Watch
Developing Synthetic Control Arms Using Bayesian Models
Adaptive Multi-Arm Multi-Stage Designs: A Comparison of Methods
