The Department of Health (DOH) of the Executive Yuan issued an announcement on December 12, 2000, the so-called “Double Twelve Announcement”. A Guidance of Bridging Study “Ethnic Factors in the Acceptability of Foreign Clinical Data” was announced on May 29, 2002. The bridging study evaluation was implemented completely since January 1, 2004, according to the Double Twelve Announcement. The sponsor should apply the bridging study evaluation in accordance with th Double Twelve Announcement, and design the appropriate bridging study protocol(s) to DOH for evaluation in accordance with the recommendation of evaluation.
Since January 1, 2001 to December 31, 2006, a total of 267 applications for Bridging Study Evaluation (BSE) were received and evaluated by the Department of Health of the Executive Yuan, in accordance with the “Double Twelve Announcement”, the “Assessment Flow Chart for the Need of Bridging Study”, and the “Bridging Study Check-list”. Among these, 234 cases have been completed and closed. The average waived rate is 62.4%.
Figure 1 Total BSE cases / year
Table 1. The case number and rate of bridging study waiving in each year
year |
Waived |
Not waived |
Rate of waiving |
2001 |
11 |
7 |
61% |
2002 |
25 |
3 |
86% |
2003 |
20 |
12 |
61% |
2004 |
27 |
17 |
61% |
2005 |
18 |
23 |
44% |
2006 |
45 |
26 |
63% |
Table 2. The case number and rate of bridging study waiving classified according to domestic and import cases from 2001 to 2006
year |
Waived |
Not waived |
Rate of waiving |
2001 |
11 |
7 |
61% |
2002 |
25 |
3 |
86% |
2003 |
20 |
12 |
61% |
2004 |
27 |
17 |
61% |
2005 |
18 |
23 |
44% |
2006 |
45 |
26 |
63% |
According to the announcements regarding the conditions for waiving domestic clinical trials, since June, 2001 the Department of Health has given authorization to the CDE to evaluate applications of “Clinical Trial Waiving (CTW)”. By December 31, 2006, a total of 151 applications have been received and evaluated. Among these, 136 were completed and closed. The average waived rate is 67.6%.
Figure 2 Total CTW cases / year
Table 3 The rate of domestic clinical trial waiving in each year
year |
Waived |
Not waived |
Rate of waiving |
2001 |
12 |
8 |
60% |
|
2002 |
16 |
8 |
64% |
|
2003 |
29 |
4 |
85% |
|
2004 |
15 |
8 |
60% |
|
2005 |
11 |
11 |
50% |
|
2006 |
9 |
5 |
50% |
|
Table 4 The case number and rate of domestic clinical trial waiving classified according to domestic and import cases from 2001 to 2006
|
Domestic cases |
Import cases |
Total |
Waived |
9 |
83 |
92 |
Not waived |
8 |
36 |
44 |
Total |
17 |
119 |
136 |
Rate of Waiving |
52.9% |
69.7% |
67.6% |
|
