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Demystifying Synthetic Control Arms

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Last week, Cytel Director & Research Principal Louis Dron discussed new FDA guidance on the design and conduct of trials incorporating an external control group, sometimes known as a synthetic control arm. But what are synthetic control arms and what are the potential benefits to this clinical trial design?

This week’s Winter Weekend Read features our ebook “Demystifying Synthetic Control Arms,” which provides an introduction to this single-arm trial design and discusses:

  • Propensity scoring methods
  • Bayesian dynamic borrowing

It also includes an illustrative case study of non-small cell lung cancer and a series of questions sponsors should ask when considering a choice between placebo-controlled and single-arm trials.

To download the complimentary ebook, click below:

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The Winter Weekends Reads series features complimentary publications on a variety of topics on clinical trial design and data science. Subscribe to our weekly newsletter below and never miss a post!

 

Read more from Perspectives on Enquiry & Evidence:

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FDA Guidance on the Design and Conduct of Externally Controlled Trials — What to Watch

The U.S. FDA has recently provided specific guidance[i] on the design and conduct of trials incorporating an external...
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Introduction to Evidence Synthesis and Bayesian dynamic borrowing

In the last few years, there has been a growing interest in historical borrowing or augmented trials. There is an...
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Estimator Choice in Synthetic Control Arm Analyses

Synthetic control arm (SCA) methods are statistical methods that are seeing rapidly increasing use in comparative...
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