약효 있을 환자만 선별하는 '동반진단 임상시험' 국내 본격화

Clinical trials to test the efficacy of new drugs not only cost companies a lot of money -- only a few of them ever lead to a drug reaching the market.
Trials are complicated by the fact that each person's genetics can mean they respond differently to drugs even when they have the same disease.
That's where genetic screening comes in, a technique now used in Korea that can make trials much more successful.
Lee Eun-jin has this report.

This bio company analyzes the genetics of cancer patients.
They've started clinical research on metastatic breast cancer in partnership with Samsung Medical Center...
and they're using a method that screens patients in advance of the clinical trial.

"We use our device with a drug developed by Pfizer and Roche that targets major biomarkers... which allows only patients with specific biomarkers to be screened for specific clinical trials."

In the bio-pharmaceutical industry, there is a diagnostic test used to match a patient to a specific drug or therapy by determining the drug's applicability to specific individuals. This test is called companion diagnostics.
Another domestic bio company is using companion diagnostics for lung cancer patients for clinical trials in the U.S.
Using this test in the initial stages of clinical trials improves the efficacy of the drug... as patients with the disease-causing genes would be pre-screened as subjects.

"In 2016, a decade's worth of results showed that getting drug approval was 3 times higher when patients were selected using biomarkers,... especially for anti-cancer drugs."

In the United States, drug companies developing anti-cancer drugs targeting specific genes... have been recommended to use companion diagnostics... since 2014.
And when a new drug is approved based on results from companion diagnosis, only those screened patients are allowed to be prescribed the new medicine.
As this method highlighted a reduction in terms of cost and duration of clinical trials, further attempts have been made in Korea.
Experts have high expectations for more patient-specific treatment... with companion diagnostic tests reducing unnecessary prescriptions and maximizing the effect of treatment.
Lee Eunjin, Arirang News.



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2022-11-06, 18:00 (KST)

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