A phaseⅢclinical trial in Asia-experience from the Asian Sildenafil (Viagra~TM)efficacy and safety study(ASSESS)

摘要

The ASSESS experience demonstrates that it is possible to conduct a large multi-center double blind placebo controlled ICH-GCP standardized PhaseⅢclinical trial in Asia. However, re- Searchers and sponsors need to be prepared to Address bureaucratic and often-cumbersome admi- Nistrative/regulatory issues, which could even Delay study start in a particular country. It is Expected that with careful preparation and Intensive training PTSS, the data quality will be Shown to be comparable to US/EU studies that Have been performed in highly experienced Centers.