AsianScientist (Aug. 1, 2014) – In an analysis of 44 multiregional clinical trials, scientists conclude that pan-Asian studies provide sufficient information to approve new drugs for Japan. This study has been published in The Journal of Clinical Pharmacology.
Underlying genetic and cultural differences between Caucasian and Asian populations necessitate the replication of drugs trials. This is particularly true for diseases such as diabetes, for which there are known differences in the pathophysiology of disease. Because of this, the Japanese drug regulatory agency typically requires that drug studies be performed in Japanese people before approval. However, it can be extremely expensive and time consuming to repeat clinical trials, which increase the final cost of the drug for the patients and delay access.
In this study, led by Dr. Koji Chiba from Keio University, the authors studied multiregional clinical trials conducted in Asia and worldwide to see if the trials conducted in Asia were of a sufficient quality to allow them to extrapolate the results to the Japanese population.
They found that Asian studies, defined as studies conducted in Japan, South Korea, China, Taiwan, Hong Kong, Indonesia, Malaysia, Philippines, Singapore, Thailand, and India, were mainly done for drugs already approved in the US or the EU. Asian studies also tended to have smaller sample sizes and a higher proportion of Japanese participants than worldwide studies.
The authors concluded that wider Asian studies would increasingly be used in submissions for new drug applications (NDA) in Japan as well as the rest of Asia, thanks to recognition of and compliance with International Conference on Harmonization (ICH) guidelines. This would allow drugs to reach Asian populations quicker than before.
The article can be found at: Shirotani et al. (2014) Comparison of Global versus Asian Clinical Trial Strategies Supportive of Registration of Drugs in Japan.
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