국가임상시험지원재단

● Quility Improvement of a CTC by Certification Program

Min-Gul Kim(Chonbuk National University Hospital)

Clinical trials in South Korea have shown dramatic increase in number within the last decade. As of 2017, South Korea ranks 6th in the world for the number of clinical trials conducted; when broken down by city, Seoul ranked highest according to ClinicalTrials. gov registry. However, with the good news came the bad news: global clinical trials are decreasing in number. Clinical trial protocols registered at ClnicalTrials.gov have decreased in number by 16.3% in 2017, and have been so within the past 3 years. Hence, now is the time where investigators and clinical trial conducting sites must consider improving quality of clinical trials rather than expanding in number. And improving the quality of clinical trials is not possible without the close collaboration with the hospitals, where the clinical trial conducting sites are nested within.
 A certification program of CTCs is one of the ideas that could help expanding the scope of clinical trials conducted in South Korea. Our goal is: to improve the quality of clinical trials conducted in South Korea
 A certification program of CTCs is one of the ideas that could help expanding the scope of clinical trials conducted in South Korea. Our goal is: to improve the quality of clinical trials conducted in South Korea?

● Overseas Engagement of Clinical Research to Develop Academic Seeds: Efforts of Osaka University Hospital

Daisaku Nakatani(Osaka University Hospital)

Osaka University Hospital, a leading hospital for research and development in translational and clinical researches in Japan, was appointed for the Global Clinical Trial Development Project led by the Japan Agency for Medical Research and Development (AMED) in October 2016. Since then, the Global Clinical Research Support Group (GCRSG) was launched within the Department of Medical Innovation (DMI). The GCRSG organized Japanese consortium of clinical research core hospitals (J-CCRC), consisting of 12 clinical core hospitals across Japan that the Ministry of Health Labor and Welfare has certified, because of fulfilling criteria such as compliance with ICH-GCP and appropriate ethics screening. The aim of the J-CCRC is to share issues that are needed to be resolved when conducting global clinical researches in academia. Another aim is to collaborate with other consortia in various countries. This may help investigators to find appropriate institutions to conduct global clinical research smoothly.　As of August 2018, GCRSG supports 14 global clinical researches. Of those, 6 are from investigators in Osaka University Hospital, 8 are from researchers outside of the hospitals. Unlike industries, research focus in academia for global clinical research may include rare diseases, infectious diseases in tropical area and surgical techniques that pharmaceutical companies are not willing to deal with. Among 4 projects for infectious diseases that we are supporting, one is Neglected Tropical Diseases (NTDs), two are considered to be three major infectious diseases. The remaining one is for viral infectious disease. One project that we supported has already started successfully in West African country. The other 3 will be also conducted in African countries, soon. We also support global registry studies in order to explore and collect clinical data on patients’ characteristics, treatment and outcomes before starting clinical trials. This 2-stories strategy may help to develop an adequate protocol and patients’ recruitment from the registry for global clinical trial to get regulatory approval. In this conference, we would like to introduce our efforts for supporting global clinical researches. We believe that our efforts would help to proceed global clinical researches and get regulatory approval for new drugs, devices and regenerative medicine that are derived from academia.

● Evolution of Clinical Trials Centers in Korea

Min Soo Park(Yonsei University College of Medicine)

What is a clinical trials center to you? A place where all the clinical trials are conducted? Or a unit that has a certain scope of supportive activities? Or a CRO-like institution where mainly phase 1 or 2 studies are conducted? Yes, it depends. A clinical trials center can be shaped as needed or as desired. It can be of diverse forms and functions depending on the site (leadership, vision, financial status, existing expertise, requests from investigators or even industry, and surrounding environment).
With the start of Global Centers of Excellence Program in 2012 and Research-driven Hospitals Program in 2013(?) by the Ministry of Health and Welfare, many centers attained the recognition within their hospitals as essential infrastructure for clinical research. CTC’s took up a new role as a gateway to the vast resources within hospitals for clinical as well as translational research opportunities. Up to the present moment, the centers in the form of consortium have made many daring challenges in a wide variety of aspects and directions and have paved the way to the next stage of an upgraded centers in coming years.
Since late 2000’s a government program-driven movement to train clinical trials professionals was initiated to meet the needs of CTC’s and industry. As the pool of clinical research professionals grew rapidly, and at the same time as the demands from global industry increased both quantity-wise and quality-wise, CTC’s had to take in more personnel to expand the scope of their services as well as to increase the quality provided by experienced professionals with specific job titles, such as QC/QA, project managers, lab techs, biostatisticians, data managers, contract managers, etc. Still the majority of CTC’s were standalone units within hospitals but without definite roles in hospitals. Clinical research was not actually a main responsibility of hospitals. Some centers achieved their solid ground as a permanent unit within their hospitals. Some still challenged by hospital officials and colleagues for the validity of their existence and contribution within hospitals.
With the start of Global Centers of Excellence Program in 2012 and Research-driven Hospitals Program in 2013(?) by the Ministry of Health and Welfare, many centers attained the recognition within their hospitals as essential infrastructure for clinical research. CTC’s took up a new role as a gateway to the vast resources within hospitals for clinical as well as translational research opportunities. Up to the present moment, the centers in the form of consortium have made many daring challenges in a wide variety of aspects and directions and have paved the way to the next stage of an upgraded centers in coming years. ?

1. Min-Gul Kim(Chonbuk National University Hospital)

2. Daisaku Nakatani(Osaka University Hospital)

3. Min Soo Park(Yonsei University College of Medicine) 

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