Facilitating large-scale clinical trials: in Asia.
The number of clinical trials conducted in Asian countries has started to increase as a result of expansion of the pharmaceutical market in this area. There is a growing opportunity for large-scale clinical trials because of the large number of patients, significant market potential, good quality of data, and the cost effective and qualified medical infrastructure. However, for carrying out large-scale clinical trials in Asia, there are several major challenges, including the quality control of data, budget control, laboratory validation, monitoring capacity, authorship, staff training, and nonstandard treatment that need to be considered. There are also several difficulties in collaborating on international trials in Asia because Asia is an extremely diverse continent. The major challenges are language differences, diversity of patterns of disease, and current treatments, a large gap in the experience with performing multinational trials, and regulatory differences among the Asian countries. In addition, there are also differences in the understanding of global clinical trials, medical facilities, indemnity assurance, and culture, including food and religion. To make regional and local data provide evidence for efficacy through the standardization of these differences, unlimited effort is required. At this time, there are no large clinical trials led by urologists in Asia, but it is anticipated that the role of urologists in clinical trials will continue to increase.
Department of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea. hanchoi@skku.edu
Han Yong
HY
Choi
Jae-Wook
JW
Ko
D000970:Antineoplastic Agents / Q000627:therapeutic use; D001208:Asia; D002986:Clinical Trials as Topic; D006801:Humans; D012107:Research Design; D014571:Urologic Neoplasms / Q000188:drug therapy*
D000970:Antineoplastic Agents