Japan has taken significant steps in establishing itself as a major player in the global clinical research community, driving the demand for more clinical trials across East Asia as a result. By officially acknowledging and seeking clinical data from the Asia-Pacific region, Japan is facilitating a dialogue with one of the most powerful and capable clinical trial landscapes in the world: South Korea.
In the second part of our three-part blog series, Philip Gregory of George Clinical – CRO China will highlight South Korea’s capabilities and provide insight on its recent clinical research developments that are driving innovation across the Asia-Pacific region.
In comparison to Japan, South Korea has had a longer history of conducting global clinical trials. In fact, more than 80% of clinical trials conducted in South Korea are global. It has also recorded more clinical trials than any other Asian country between 2001 and 2012.
Compared to other Asian countries, South Korea has a sophisticated infrastructure, a relatively large population and a sizeable market of 17 billion USD. In comparison to Japan’s mature economy, the cost of conducting research is lower and is less complex. For example, Korea’s Good Clinical Practice guidelines (GCP) have been consistent with the global International Conference on Harmonisation GCP since 2000, whereas Japan’s GCP guidelines are still not yet completely harmonized with ICH GCP.
As of late, there has been increasing support from the government to enhance this industry as well. In 2013, the Korean Food and Drug Administration (FDA) saw a significant increase in authority, as it was elevated to Ministry of Food and Drug Safety. The already well-established regulatory infrastructure has continuously improved over the past 10 years. Examples of recent developments include the ability for regulatory review of English protocols for phase I clinical trials in 2014, and development and publication of guidelines on clinical investigational medicinal products.
Besides working to improve the regulatory environment, South Korea’s government also provides support through other means. The South Korean government has invested in the clinical trial infrastructure to develop world-class sites, expand clinical trial capacity, and advance the capabilities of clinical study professionals. The Regional Clinical Trial Center, introduced in 2004, and the Korea National Enterprise for Clinical Trials (KoNECT), introduced in 2007, are two such institutions that support South Korea’s clinical trial infrastructure. KoNECT’s purpose is to assist clinical trial centers in developing their infrastructure and human resources.
There are other organizations set in place for the support of South Korea’s clinical research community, such as the Korea Innovation and Collaboration Center for Global Clinical Trials (K.I.C.C.). This center provides services such as office facilities for new entries to Korea, assisting in clinical trial planning and vendor selection, formation of investigator networks in Asia, and hosting valuable information such as investigator and patient databases.
The number of qualified investigators and quality clinical research sites in South Korea has increased. The institutional review board (IRB) process is well established, and there are a host of training programs for investigators and GCP inspectors. Recently, several electronic resources have also been introduced. For example, a clinical trials e-registration system which immediately opens after IND approval, and a self-registration system for contract research organizations (CROs).
We expect that South Korea will maintain its position as the leading destination for clinical trials in the Asia-Pacific region. It has a sophisticated clinical trial infrastructure with many available resources. The expected increase in demand for East Asian trials will also drive the growth of global clinical trials in South Korea.
As South Korea leads the way in global clinical research among the Asia-Pacific countries, it is enabling constructive collaboration that will help distinguish its neighbors as major players in clinical trials as well. In the final part of our three part blog series, we will be discussing the exciting opportunities and complex challenges of conducting clinical trials in China.