Synthetic Control Arms in Clinical Trials and Regulatory Applications

Harvard Medical School Online Webinar


12:30pm - 1:00pm

As an increasing number of rare diseases and disease subsets become tractable to novel therapies, there is growing pressure to increase the efficiency and effectiveness of clinical trials. One such approach is the use of real-world evidence, such as synthetic control arms. Instead of recruiting patients who have been assigned to the control arm, a synthetic control arm can repurpose historical clinical trial or real-world data to accurately match patients. This methodology has far-ranging applications in trial design, replacement/augmentation of control groups and identifying differentiation in treatment effects across subpopulations.

This webinar will discuss the methodology and applicability of synthetic control arms, especially those utilizing large clinical trial datasets, in biopharma R&D. We will also discuss examples where synthetic controls have successfully been used in FDA applications, and the emerging regulatory framework.

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Contact: Tess MacCurdy
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