The real-world company AppliedVR is launching a new experimental approach for the treatment of chronic pain. Instead of trying to find a group of people with chronic back pain to sign up for a test and it is not receive treatment, they will extract existing data from chronic pain patients to use the comparison group – a strategy capable of performing patient tests efficiently.
AppliedVR received approval from the Food and Drug Administration for its truly effective system for treating chronic back pain in November. Now, the company is gathering more information on how treatments work in different groups in the real world. They are experimenting with the healthcare information company Komodo Health. Komodo provides its customers with access to an extensive collection of unnamed patient health records from people with a variety of medical conditions, including chronic pain, who follow up over time.
The partnership allows AppliedVR to monitor the experiences of patients with chronic low back pain in general and compare their experience to people who are actively enrolled in the trial. “Now, as they move forward, they will be able to clearly understand and demonstrate the value of their technology and what it offers compared to traditional chronic pain treatment,” said Web Sun, president and founder of Komodo Health. .
Using real-world data as an experimental patient group, often referred to as a synthetic control hand, can make research experiments more efficient – companies do not have to do legal work to enroll more people in clinical trials. They can also allow any patient who actively decides to enroll in the trial to receive the experimental treatment, rather than risking signing up only to receive placebo. Synthetic control groups can also improve the accuracy of patient research, the Sun said. Historical distrust of the minority health system and low access to health care often means that minorities are underrepresented in clinical trials. Komodo data contains information on patient races and ethnicities, so research teams can merge into specific groups, he said.
“That allows us to look at all the different subdivisions and the underprivileged patients to see if they have different results,” he said.
This experimental design method is still relatively new – experts are happy with its capabilities, but it is not used consistently. Researchers are still working to double-check whether it can produce accurate results such as a standard control group and identify which types of tests can work best. “The FDA is still wary of experimental design prototype control designs designed to replace traditional data due to concerns that synthetic data is not a one-size-fits-all for traditional data,” said Arnaub Chatterjee, senior product VP at Data Company Medidata Acorn AI, said Voice Pharmacy.
But the agency is very pleased with this type of data, especially if it includes more traditional patient groups, Chatterjee said. Some groups have begun to use the patient arm for studies that will include FDA approval applications: FDA said 2020 that a drug company could use the synthetic control arm in an experimental cancer treatment.
Sun said he hopes the test will be popular. “Regulatory agencies are on this path because they recognize all the obstacles in the trials,” he said. “It saves time and money, but most importantly, it represents an opportunity for us to accelerate the development of new treatments and deliver them faster, cheaper, and in a representative way.”