Dr. Hye-geol Hong shares 4 truths about 'clinical trials'

Some people may think that the drug is used in developed countries and clinical trials are conducted in other countries. On the contrary, clinical trial participation is high in developed countries. The countries with the highest clinical trial participation rate are developed countries such as the United States, Japan, Germany, and France. Among them, the U.S. is the country with the most clinical trials, with 160,000 participants in 20 years.

2. Provide an opportunity to cure incurable diseases free of charge

Gleevac, the first approved drug for the treatment of chronic myeloid leukemia, dramatically improved survival rates in cancer patients during clinical trials. When you participate in a good clinical trial that is compatible with the patient, you have the advantage of having the opportunity to cure the disease free of charge. It's not just a bad experiment that takes advantage of patients, it can be a much-needed opportunity for patients who are desperate for treatment.

3. It's safer than feared

Many patients are more worried about the side effects than the benefits. It may be an overly worrying thing. Clinical trials are strictly monitored by experts according to well-formulated guidelines. Before participating, a preliminary check is carried out to determine whether a suitable candidate is present, and a scientifically designed process is followed to evaluate the efficacy and safety of clinical trials. In addition, if you do not want to participate due to reasons such as suffering from side effects, you can stop participating midway.

The core procedure to prove the effectiveness compared to existing treatments is also guaranteed up to phase 1~4. Phase 1 and 2 are filtering processes to determine the stability and efficacy of a small number of people, and if the conditions are not met, it cannot be moved to Phase 3.

In the 1950s, a large number of babies with hand and foot abnormalities were born in Europe as a side effect of a morning sickness drug called thalidomide. If pre-market clinical trials had been carried out for the drug, such a major event could not have been avoided. Clinical trials not only verify efficacy, but also prevent possible side effects.

4. It doesn't just apply to newly developed drugs

Many people think that clinical trials only apply to new drugs. Of course, we also proceed with newly developed medicines, as well as existing medicines and new uses. For example, clinical trials may be conducted to confirm the hair growth function of a prostate drug and to use it as a treatment for alopecia.

In addition, we conduct clinical trials for the first time on a drug and conduct clinical trials even before it is used in other countries from the country where it has been approved. This is because there are ethnic and genetic differences unique to the people of each country, and there is a risk of adverse effects in the population. This is why even if it is approved by the FDA in the United States, it will take several more years for it to be used in Korea.