• Melva Louisa, Masahiro Takeuchi, Rianto Setiabudy, Nafrialdi, and Madoka Takeuchi.
• Department of Pharmacology and Therapeutics, University of Indonesia, Indonesia. melva.louisa@gmail.com
• Acta Med Indones. 2012 Jan 1; 44 (1): 71-7.

AbstractClinical trials increasingly occured in Asia during the past years as pharmaceutical industries embraced globalization in the clinical research fields. The trend is true with phase III clinical trials but not for early stage/phase I clinical trials in Asian countries is still under-represented. The conduct of phase I clinical trials is considered more sophisticated and difficult than the later stage clinical trials. There are continuing concerns from the pharmaceutical industries about the capacity of Asian countries in conducting this type of clinical trials. We highlighted several problems concerning the ethical and scientific issues, the implementation of ICH-GCP and local regulations, investigators and clinical trial subjects. The purpose of this paper is to give some perspectives addressing the problems in conducting phase I clinical trials. Improving collaboration and capacity building among the Asian countries is a solution that we proposed in order to increase the quality and quantity of phase I clinical trials in Asian countries.

20 keywords...

hide…