Synthetic Control Arms Study
A Synthetic Control Arms Study is a clinical study that ...
References
2019
- https://www.statnews.com/2019/02/05/synthetic-control-arms-clinical-trials/
- QUOTE: ... Synthetic control arms represent a way to take a safe (as well as time- and money-saving) leap forward into real-world evidence. They work like this: Instead of collecting data from patients recruited for a trial who have been assigned to the control or standard-of-care arm, synthetic control arms model those comparators using real-world data that has previously been collected from sources such as health data generated during routine care, including electronic health records; administrative claims data; patient-generated data from fitness trackers or home medical equipment; disease registries; and historical clinical trial data.
The benefits to the pharmaceutical industry are clear. By reducing or eliminating the need to enroll control participants, a synthetic control arm can increase efficiency, reduce delays, lower trial costs, and speed lifesaving therapies to market. Imagine a trial that needs to include have 500 participants in the treatment arm in order to demonstrate the effectiveness of a new therapy. Instead of having to recruit 1,000 patients — 500 for the active arm, 500 for the control arm — only 500 participants need to be recruited when a synthetic control arm is employed.
This kind of hybrid trial design presents a less risky way for sponsors to introduce real-world data elements into regulatory trials, and can also reduce the risk of late-stage failures by better informing go/no-go development decisions.
Fear of being assigned to placebo is one of the top reasons patients choose not to participate in clinical trials. This concern is amplified when an individual’s prognosis is poor or the current standard of care has limited effectiveness. Using a synthetic control arm instead of a standard control arm ensures that all participants receive the active treatment, eliminating concerns about treatment assignment. This addresses an important participant concern and also removes an important barrier to recruitment. ...
- QUOTE: ... Synthetic control arms represent a way to take a safe (as well as time- and money-saving) leap forward into real-world evidence. They work like this: Instead of collecting data from patients recruited for a trial who have been assigned to the control or standard-of-care arm, synthetic control arms model those comparators using real-world data that has previously been collected from sources such as health data generated during routine care, including electronic health records; administrative claims data; patient-generated data from fitness trackers or home medical equipment; disease registries; and historical clinical trial data.