Trends of clinical trials from 2017 to 2019 in Korea: an integrated analysis based on the Ministry of Food and Drug Safety (MFDS) and the Clinical Research Information Service (CRIS) registries

Abstract

Public disclosure of approved clinical trials in a reliable registry can provide the transparency of the study. Although the registration of clinical trials has increased remarkably, the integrity of the data is not always satisfactory. In this study, we analyzed public clinical trial databases updated by the Ministry of Food and Drug Safety (MFDS) and Clinical Research Information Service (CRIS) registry to provide an overview of the trends of clinical trials approved between 2017 and 2019 in Korea. Information on clinical trials approved between January 1, 2017 and December 31, 2019 was collected from two databases. Trial information was categorized and summarized by study phase, therapeutic area, and location of the participating centers. A total of 655 to 715 clinical trials were newly approved annually by MFDS during the period from 2017 to 2019. Phase 1 clinical trials accounted for the largest proportion (31.0%), followed by phase 3 (29.5%), investigator-initiated trials (24.1%), phase 2 (14.6%), and phase 4 (0.5%). The number of clinical trials classified as an Antineoplastic and immunomodulating agent was the greatest (40.1%) regardless of the study phase. The similar result was obtained from CRIS registry where therapeutic area Neoplasms (15.9%) accounted for the largest number. The number of clinical trials performed in Seoul and Gyeonggi-do was approximately 70% of the total trials. In conclusion, our study provided a comprehensive overview of clinical trials in Korea from 2017 to 2019. The discrepancy between clinical trial registries could be resolved by introducing standardized database and guidelines.

Feasibility study for a fully decentralized clinical trial in participants with functional constipation symptoms

“…Another consideration for recruitment is geographic accessibility. In our previous study, we found that ~70% of clinical trials in South Korea were conducted in the metropolitan area (Seoul and Gyeonggi‐do) 27 . Similarly, most participants (76.3%) are from the metropolitan area in this study.…”

“…In our previous study, we found that ~70% of clinical trials in South Korea were conducted in the metropolitan area (Seoul and Gyeonggi-do). 27 Similarly, most participants (76.3%) are from the metropolitan area in this study. However, the proportion of participants from other regions was increased.…”

“…However, the proportion of participants from other regions was increased. The regions previously accounted for only 5% of total clinical trials in South Korea, 27 but they accounted for 26.7% of total subjects in this study. As participants in the regions took greater than 2 h to visit the trial site, they could benefit from the DCT.…”