Best Practices For Conducting Multinational Clinical Trials | Page 11

As with most of the other countries, the Taiwan GCP is based on the

monitoring is implemented. In addition, there may be a significant

ICH-GDP. The clinical trial sites have passed inspection by the US FDA,

difference in supportive care, which can affect outcomes.

EMA, and Pharmaceuticals and Medical Devices Agency (PMDA).
Competition for patients and limited access to treatment naïve patients
In Vietnam, there is a GCP training program for investigators offered

are issues in countries with smaller populations and excellent research

by the Ministry of Science and Technology. In an effort to improve

environments (e.g., Singapore). In contrast, fewer competing trials in

the research environment, a working group was formed in November

countries with less clinical trial experience (e.g., Vietnam) increase the

2013 to address a variety of topics over the next two years, including

availability of patients.

improved trial management processes, streamlined processes to
improve trial efficiency and quality, and training for investigators
and ethics committees.

Figure 5.

Variations That Cause Differences in Dosing

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