Best Practices For Conducting Multinational Clinical Trials | Page 5

Important considerations before conducting
a clinical trial in Asia »
Despite the increasing similarities between the US and European
countries, which have been conducting clinical trials for decades, and
Asian countries, which have been conducting clinical trials for only the
last 15-20 years, there are still varying levels of experience, particularly
in countries like Vietnam where such experience is limited as compared
to Korea or Taiwan.
However, with experienced CRO partners, such as Clinipace Worldwide,
these considerations can be accounted for and incorporated into the
early development of the trial protocol, saving considerable time and
expense and allowing expansion of clinical trial activities into these
high-growth areas.

Figure 4.

Considerations Before Conducting a Clinical Trial

Protocol development
Historically, trial protocols were developed in the US and Europe for
US and European-based studies, and these protocols were then applied,
as is, in Asia. In the interest of accommodating these protocols, a
number of Asian countries attempted to follow what had been developed
elsewhere (>10 years ago). With the growth of local pharmaceutical
and biotech companies in the Asian region during the last 5 years,
protocols reflecting regional requirements are now being developed
locally, and protocols developed elsewhere without specific Asian
considerations are no longer readily accepted.
Sponsors in the US and Europe wishing to conduct multinational
trials in Asia should incorporate local Asian requirements in the initial
protocol development, rather than as an afterthought. Moreover,
each autonomous nation should be considered its own entity with
regards to regulations, culture, and ethnicity, rather than the whole
of Asia as one homogenous unit. This will ultimately save time in the
approval process and facilitate proactive solutions to considerations

Protocol development
Specific regulatory
considerations by country
Timelines
Standard of care
Data quality
Recruitment
Pharmacokinetics/dosing

such as local standard practices, comparator availability, and
dosing requirements.
Specific regulatory considerations by country
In China, active management of regulatory affairs is particularly
important; the application process involves a number of regulatory
bodies at various levels of the central and local governments. Separate
Good Clinical Practices (GCP), Good Laboratory Practices (GLP),
and Good Manufacturing Practices (GMP) standards must also
be accommodated.

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