Downloadable White Paper | Synthetic Control Arm® in Clinical Trials

Downloadable White Paper

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.

Download this 10-page white paper analyzes how a Synthetic Control Arm® can benefit your trials, including:

  • Defining a Synthetic Control Arm®
  • Components needed to build a Synthetic Control Arm®
  • Benefits for patients and sponsors
  • Case studies in non-small-cell lung cancer (NSCLC), multiple myeloma, and from Celsion Corporation 
Synthetic Control Arm® in Clinical Trials