Examining Clinical Research in South Korea

16th August 2016 (Last Updated July 18th, 2018 09:38)

Nadia Kim examines the potential of clinical research in South Korea

Examining Clinical Research in South Korea

Over the last 10 years, there are likely no countries in Asia to experience such rapid developments in the clinical trial market than South Korea. In that period, many of the large global pharma companies entered Seoul seeking access to the country’s broad patient pool. Meanwhile, local Korean pharma companies started focusing on developing new drugs of their own as the government sought to boost the bioscience industry. Although the country has a large patient pool, the talent, technology, infrastructure, and government support, chances are that development will continue for another decade.

However, there might be a barrier to this.

Even though there has been rapid development in clinical research in South Korea, for the wider population, there is limited knowledge about clinical trials. Indeed, this lack of awareness has fostered negative opinions of clinical trials and could potentially hinder patient recruitment.      

As a result, in August 2015, the Korean government announced new initiatives in an attempt to become a hub for clinical research in the Asia-Pacific region. In effect, new regulations on clinical trials were introduced as a way to encourage more clinical research. A local NGO then protested against the policy suggesting the government was treating its citizens like guinea pigs. They argued that, while about 500 – 600 clinical trial applications are approved every year, 476 patients have suffered side effects in the last three years.[1]  

Out of 476 people, 376 were hospitalised due to side effects, seven people experienced life threatening conditions, 49 people passed away, and 45 people showed medically significant symptoms.[2] This has significantly increased the negative view of clinical trials in the nation. This unfavourable perspective was once again raised when one of the major television channels broadcasted the dangers of clinical trials months after the incident.

Clinical trials are critical to supporting new drug development, and the negative view of clinical trials could potentially curtail trial activities as well as drug development. Thus, changing people’s perception is vital if South Korea is to become one of the world’s clinical trial hub. 

There should be significant attempts made to train qualified professionals on ethics. In order to achieve this, integrated efforts from various concerning parties, such as the government, investigators, sponsors, and the ethics committee are required. This is what the government, pharma companies and investigators are attempting to promote ethically sound and patient-friendly clinical trials.

The Government

The Korean government established an organisation, the Korea National Enterprise for Clinical Trials (KoNECT) in 2007 to boost the medical industry, human resources and core technologies in this area. This organisation endeavours to provide continuous education to clinical professionals by hosting regular training sessions and seminars. With the government’s new regulation, KoNECT will provide trainings to all clinical professionals for 40 hours every year to reinforce patient ethics.  

The Pharma Companies

Many of the pharma companies are attempting to conduct more patient friendly trials as possible. For example, some sponsors are adopting multimedia to improve patient engagement and education. Patients are able to access information about the drug and the trial from their mobile phones, and it has received positive feedback.  

The Investigators

As investigators work directly with patients, it is important more investigators become enthusiastic and engaged in their studies. It is also important to be informed with GCP to conduct the trials accordingly to regulations to ensure patient’s safety as well as for the quality of clinical trial data. All of Korean clinical sites are approved by the Association for the Accreditation of Human Research Protection Program (AAHRPP) as well. Hospitals are organising internal events to brainstorm how to be more engaged with patients.

 

While the responsibilities significantly lie on those who lead the clinical trials, clinical trial professionals have expressed patients must inform them when there is a symptom of a side effect. As they are often afraid not to receive the full fee, some of them decide not to reveal it.

Clinical trials are critical to human life. New drugs and better drugs will help to save those who suffer from diseases. Yet, there should be a greater safety net to protect those who participate in the studies to benefit society as a whole.

 

References

[1] http://www.yonhapnews.co.kr/bulletin/2015/11/16/0200000000AKR20151116118600017.HTML?input=1195m (NB. This article is in Korean)

[2] http://www.yonhapnews.co.kr/bulletin/2015/11/16/0200000000AKR20151116118600017.HTML?input=1195m (NB. This article is in Korean)