An external comparator or control (sometimes called a synthetic control) is aggregated, real world data (RWD) from patients that are similar to your clinical trial population.
We identify trial-like patients in our RWD sources based on your trial’s eligibility criteria and capture outcomes on those patients that align with the clinical trial protocol.
Your researchers can use an external comparator to understand how trial-like patients progress without exposure to the interventional product from your trial. Comparisons can be made between the treated and untreated populations to understand how well your investigational product works. This evidence can be used to enhance your submissions to regulators and payers.
Trials designed as single-arm, or uncontrolled, have comparative evidence gaps that can be bridged with external controls or comparators. An analysis of IQVIA’s Health Technology Assessment Accelerator indicates that submissions relying on a pivotal single-arm clinical trial are more likely to receive a positive HTA decision if an external control or comparator from RWD is also included in the submission.