| 초록 |
Chronic kidney disease (CKD) affects around 10% of adults and is substantially increasing in number of patients as well as in social burden that lead so many drug trials worldwide and in Korea. Regulatory, Political and Demographic conditions in Korea are favorable for global, local and regional clinical trials. Furthermore, high quality clinical research infrastructure and diverse population, Korea is now one of the top destinations for clinical trials. These points make nephrology drug clinical trials have rapidly increased in terms of quantity and quality during the last decade in Korea.
The aim of the talk is not to generate specific recommendations for particular clinical trials, but is instead to identify key issues relevant to conduct of clinical trials, to share knowledge from our local experience, and to suggest how future trials can be improved.
First part of this talk is to identify the barriers common to the conduct of the drug trials that are ongoing in patients with CKD in Korea. Some such barriers (e.g., treatment adherence) are likely to be common to most randomized trials, while other barriers (e.g., disease rarity, subject enrollment and retention) may be encountered particularly frequently in nephrology. The talk also touch on how to establish the high quality study team in each institution and nationwide.
Last part of the talk is to discuss some examples our team is conducting and to look for solutions that has been encountered. Some such examples (e.g. PHI inhibitors for renal anemia) are the most popular global trials conducting nowadays in Korea, while others (e.g. ARB for proteinuria) are domestic trials. Non-drug clinical trials (e.g. APRODITE for hypertension control) are also briefly touched. |