received US Food and Drug Administration (FDA) approval for its RelieVRx virtual reality system in November 2021. Now the company is gathering more information about how its virtual treatment works for different groups of people in the real world. Through a collaboration with healthcare data company Komodo Health, AppliedVR will track the experience of patients with chronic low back disease receiving conventional treatment and compare their data with those of those actively participating in the study. This is stated in the press release.
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Using real data, often referred to as a synthetic control group (or Synthetic Control Arm), will make trials more efficient—companies don’t have to look for a real control group of people. In addition, the Komodo database has information about the race and ethnicity of patients, so research teams can better study specific groups.
The RelieVRx system is designed to relieve pain through immersive virtual reality therapy. His work is based on pain management techniques such as interoception (body awareness), pain distraction, relaxation, and behavior modification. This approach is still new—experts are excited about its potential—but researchers are still working to double-check whether it can produce results as accurate as a standard control group.
“The FDA remains wary of trial projects in which the Synthetic Control Arm is intended to completely replace traditional data due to concerns that synthetic data does not match traditional data,” said Arnaub Chatterjee, senior vice president at Medical Company Medidata. Acorn AI writes PharmaVoice .
The FDA said in 2020 that a pharmaceutical company could use a partially synthetic control group in cancer drug trials. This approach saves time and money, and makes it possible to accelerate the development of new therapeutics and bring them to market faster and cheaper.
