The Joys and Woes of Clinical Trial Startup | Page 3

Rigorous quality control is especially important

Table 1:

in Latin America, where resubmitting or
amending any part of the application may

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

United States5,6

cause significant delays and, in some cases,
require the review to start again from the
beginning.
Compliance with Good Clinical Practices set
forth by the International Conference on

Parallel review
(in most countries)*

Czech Republic8-9

Sponsor can choose parallel or
sequential review

Poland10

Eastern Europe

Harmonization (ICH-GCP) requires that every

European Union7

trial be reviewed and approved by an IRB/EC.
Mechanisms vary widely:
•  n entire country, and all sites within it,
A
may utilize one national IRB/EC; or
•  oth national and site-level IRB/EC review/
B
approval may be required; or
•  ach individual site submits to their local
E
IRB/EC only; or
• A combination of these approaches.
In general, centralized IRBs/ECs are faster
involved, the order of submission and approval
may be parallel or sequential. In many cases,

(single application
for government and
IRB/EC approval)

Ukraine13

Parallel review

Australia7,14

Considerable variation
between states/territories

China13,15

Hong Kong16

Asia/Pacific

than local ones. When multiple IRBs/ECs are

Russia11-13

Federal regulations enacted in
2010 have shortened timelines
considerably

Parallel review

India13,15

Parallel review

regulatory (competent authority/MOH) and
at least one level of IRB/EC review can occur

Indonesia16

in parallel. When sequential submissions are
required, the order of submission (regulatory
then IRB/EC, or vice versa) depends on
the country.

Malaysia16

Parallel review

0

1

2

3

4

5

6

7
8
Months

9

10 11 12 13 14
Continued

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