Virtual reality company AppliedVR is taking an innovative approach to a new trial for its chronic pain treatment. Instead of finding people with chronic back pain to sign up for the trial and not get the treatment, they will pull data from an existing database of chronic pain patients to use as a comparison group. This is a strategy that has the potential to make clinical trials more efficient.
Innovative Approach to Chronic Back Pain
AppliedVR got Food and Drug Administration (FDA) approval for its virtual reality system that treats chronic back pain back in November. Now, it is collecting more information about how the treatment works in different groups in the real world. They’re partnering with healthcare data company Komodo Health on the trial.
The partnership lets AppliedVR track the experience of chronic back pain patients in general and compare their experience with the experience of people actively enrolled in the trial. Using real-world data as a patient group in a trial, often known as a synthetic control arm, can make research trials more efficient — companies don’t have to do the legwork to enroll as many people in clinical trials. They can also allow every patient who actively decides to sign up for a trial gets the treatment being tested, rather than risking signing up only to get a placebo.
Trial Testing in Cancer Treatment
This approach to trial design is still new — experts are excited about its potential, but it’s not in regular use. Researchers are still working to double-check that it can produce results as accurately as a standard control group and identifying which types of trials it might work best for.
But the agency is getting more comfortable with this type of data, particularly if it’s used in combination with more traditional patient groups. And some groups are starting to use synthetic patient arms for studies that will be part of applications for FDA approval: the FDA said in 2020 that a drug company could use a part-synthetic control arm in a trial testing a cancer treatment.