[Reporter’s View] Being a global clinical trial powerhouse

The optical illusions and assignments for Korea as a global clinical trial powerhouse

Korea is a global clinical trial powerhouse.

 

According to the Korea National Enterprise For Clinical Trials, Korea's share of global clinical trials was 4.04% as of 2023.

 

It is in 4th place after the United States (22.02%), China (13.59%), and Spain (4.09%).

 

By city, Seoul has been in first place since 2017.

 

Korea’s outlook is also positive.

 

Korea’s global clinical trial market share rank rose one step each year, from 6th in 2021 to 5th in 2022 and 4th in 2023.

 

The share gap with Spain is only 0.05%, and if the current trend continues, Korea is expected to rise to become one of the Top 3 clinical trial countries in the world.

 

However, there are some drawbacks.

 

Although Korea has established itself as a clear clinical trial powerhouse in terms of quantity, there are indications that it is not so in terms of quality.

 

The most straightforward example is the clinical trials related to antibody-drug conjugates (ADCs), which have recently emerged as a new trend in drug development.

 

According to the Korea National Enterprise For Clinical Trials, as of May last year, more than 600 ADC-related clinical trials were registered on ClinicalTrials.gov worldwide, but there is not a single ADC clinical trial registered or being conducted in Korea.

 

This cannot be simply attributed to Korea’s small population.

 

This is because 27 ADC clinical trials are underway in Taiwan, which has a population of about half that of South Korea.

 

It is time to improve the quality of Korea’s clinical trials.

 

In particular, improving regulations related to clinical trials may be a way to improve the quality of clinical trials.

 

From this perspective, it is encouraging that the first step has recently been taken in the development of “decentralized clinical trials (DCT)”.

 

DCTs refer to de-hospitalized clinical trials that collect clinical data using wearable or mobile devices and deliver test drugs by mail, etc.

 

Patients can participate in clinical trials without having to visit a medical institution in person.

 

A representative success story of decentralized clinical trials is Moderna, which developed the COVID-19 vaccine.

 

The industry has consistently called for the introduction of decentralized clinical trials.

 

In response, the government has decided to launch a pilot project for decentralized clinical trials starting this year.

 

The government plans to conduct 6 decentralized clinical trials during the pilot project period until 2027, and then institutionalize the system based on these trials.

 

Korea’s high-quality infrastructure is considered the main reason why Korea has grown into a global clinical trial powerhouse.

 

This includes excellent medical staff, hospital facilities, and the high level of education of clinical trial participants.

 

This has enabled Korea to become a clinical trial powerhouse in terms of quantity.

 

However, there is still much that needs to be done in terms of quality.

 

Now is the time to improve the quality of clinical trials based on excellent infrastructure.

 

Regulatory improvement is the surest way to improve the quality of clinical trials.

 

This can foster an environment in which clinical trials of advanced drugs such as ADC can be conducted in Korea.

 

Only when innovative new drugs can be developed in Korea will Korea be able to go beyond being a clinical trial powerhouse and become a pharmaceutical powerhouse.