External Control Arm

What is an external control arm? 

An external control arm is a group of patients used in clinical trials to compare the outcomes of participants receiving a new treatment or intervention to those who were not part of the trial but have similar characteristics. Unlike the traditional internal control arm, which consists of participants from the same trial, the external control arm draws data from pre-existing sources, such as historical patient data, real-world evidence, or data from other studies. This approach is particularly useful when it is difficult or unethical to have a placebo or control group within the same clinical trial. 

Why are external control arms important? 

External control arms provide a valuable tool in clinical research, particularly in situations where it is impractical, unethical, or too costly to include an internal control group. By leveraging real-world data and historical patient information, they allow for more flexible, timely, and ethical clinical trials, particularly in rare diseases or when patient recruitment is difficult. They also enable more robust and cost-effective studies, contributing to faster regulatory approvals and improved treatment options for patients.