Korea Biomedical Review- Medidata’s Acorn AI solution raises clinical trials’ success rates

Shim Hyun-tai | April 21, 2021

Medidata Korea said its total solution, Acorn AI, can reduce the cost of conducting clinical trials and increase the probability of studies’ success.

In a media event on Tuesday, the company said that Acorn AI's integrated evidence service helps increase the success rate of clinical trials by providing a data-based comparative basis for insights and comprehensively analyzing past data.

Medidata Korea said its Acorn AI solution could lower the cost of the clinical trials and increase the success rate of the studies.
Acorn AI allows users to make important decisions about clinical trials more quickly with the piled datasets. Clinical studies using the synthetic control arm (SCA) let the study proceed based only on the treatment group recruited.

The integrated evidence service is mainly used for clinical trials targeting cancer and rare diseases, where the developers have a hard time recruiting participants or may cause ethical problems in administering placebo, the company said.

"Unlike existing clinical trials that required both treatment and control groups to conduct the study, companies can push ahead with the study with only treatment group by using SCA," said Dr. Kim Na-hyun, a specialist for the sale of Medidata's Acorn AI solution. Kim added that the cost for conducting the clinical trials also decreases as researchers do not need to look for a control group.

When constructing the SCA, the data is quite reliable as the solution considers participants' diseases and information of the sites where the clinical trials had been conducted.

Medidata's solution is based on a database of clinical standards obtained from more than 23,000 clinical studies and more than seven million subjects at 1,700 client institutions globally.

The Ministry of Food and Drug Safety has not yet allowed the use of SCA in clinical trials, but the U.S. Food and Drug Administration allows the use of SCA.

For instance, Medicenna Therapeutics introduced Medidata's SCA in October 2020 for registering the phase 3 clinical trials of recurrent glioblastoma under development. It was the first phase 3 trial that used SCA and randomized treatment groups, showing the possibility of further use of SCA in the future.

Another company specializing in cancer therapy, Celsion, obtained data almost identical to the patients' characteristics of phase 1b OVATION1 trial using its GEN-1 through Medidata SCA.

Kim acknowledged that SCA is not perfect, and there could be distorted data when used in conducting clinical trials.

“However, several studies have demonstrated that SCA produces results similar to control groups in the real setting,” she said. "We try to make it more accurate by applying as many criteria as possible to real controls, such as selection and exclusion criteria, to the control group."

In 2019, Medidata partnered with Friends of Cancer Research, a non-profit cancer research group in the U.S., to conduct basic research on SCA.

The results showed that the SCA group could mimic the results of the existing randomized controlled studies closely. The studies have shown that an SCA single-arm clinical trial of a treatment for non-small cell lung cancer has the same conclusions as a randomized controlled trial of the same subject.
 

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