The Joys and Woes of Clinical Trial Startup | Page 4

Before submitting a clinical trial protocol for

Table 1, Continued:

approval, it is important to consider any countryspecific requirements, such as:
•  ypes of allowable research. For example,
T
both Russia and China allow phase I trials
only if the investigational product was
discovered and/or manufactured in the

Philippines16

Parallel review

Singapore16

Parallel review

Taiwan16

Asia/Pacific

respective country.12

Estimated Average Timelines for Clinical Trial Approval:
Regulatory + IRB/EC Review

Parallel review

•  ost-study access to medication. In some
P
countries, all patients enrolled in a clinical

Thailand16

trial must have access to the investigational
drug until either (1) it becomes

Vietnam16

commercially available or (2) the patient is
no longer deriving benefit.4
•  rovisions for standard of care. Some
P
nations require sponsors to provide all
drug needed for the trial, including the
comparator drug, if applicable, as well
as any other study-mandated items (eg,
medications).4
•  inimum insurance coverage levels
M
for each enrolled patient.17,18 These
requirements vary by country, type of trial,

Parallel review

Argentina4

Parallel review;
government is working to
streamline pr