Synthetic Control Arm® in Clinical Trials

While randomized controlled trials (RCTs) are the gold standard for evaluating the safety and efficacy of new medical treatments, maintaining a concurrent control arm is sometimes not feasible and can lead to increased patient burden and threaten the completion of a trial. The use of external controls is helpful in such clinical studies.

A Synthetic Control Arm® (SCA®) is a type of external control that is generated using external patient-level data to improve the interpretation of uncontrolled trials. External controls have been validated by showing they effectively mimic randomized controls and therefore can be used to interpret the treatment effects of an investigational product in trials lacking a concurrent control group, such as single-arm trials. They can help enhance the scientific validity of single-arm trials; in certain indications, and can reduce the amount of time and costs associated with trials, and expose fewer patients to placebos or existing standard-of-care treatments that might not be effective for them.

A series of case studies are provided to highlight the different ways an SCA has been used. Download the white paper to learn how an SCA is designed to enable better product development decisions.



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