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The Establishment of Emerging Trial Regions
The Establishment of Emerging Trial Regions
Article/Editorial/Commentaries
Editorial. The Establishment of Emerging Trial Regions.
33
OOTR 7th Annual Conference, May 1314, 2011, Hong Kong SAR, China.
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Apr 2011, Volume 4, Issue 2
It has been said that arguing against globalization is like arguing against the laws of gravity. Kofi Annan (1938-)
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Dinner conversation
During a social dinner in Dunedin, we discussed our travel experiences and visits to other countries. One gentleman told us that he wished to live half the year in the northern hemisphere and the other half in the southern hemisphere, if only he could afford it. So the question was raised, Johan, if you must choose, where
would like to live? In Stockholm, in Hong Kong or in Dunedin? I told them that I could easily live in any of
the three cities, although they are completely different. Stockholm the capital of Sweden - is a small large city with a sizable port, beautiful historical and proud buildings, clean water and clean air. Hong Kong is a financial metropolitan with one of the largest bycapacity ports worldwide, with virtually no historical buildings left, no clean water and no clean air. Dunedin is a large small city with a port, clean water and clean air. Dunedin not only houses the oldest university of the three cities, the university is the oldest in the entire southern hemisphere. In addition, Dunedin also has the oldest golf club the southern hemisphere.
Time flies
During the two connecting flights, I made two reflections. First, when we were young we played in the sandbox building castles, mountains and valleys, we joked that soon we will reach a tower of a building in
China. More correctly, it should have been a tower in Dunedin. Second, I understand why the birds are
leaving the Scandinavian countries for the southern hemisphere during the long, cold and dark winter. In fact, this is what the Scandinavians are doing today at least for a few weeks during the winter season. Maybe it is not a coincidence that the first transatlantic flight was made by Charles Augustus Lindbergh, the only child of a Swedish Native. His non-stop journey from Long Island to Paris took 33 hours and was completed in the evening of May 21, 1927. That is, this historical event took place only some 84 years ago. And it was only 61 years ago since the first non-stop transatlantic jet flight was made in 10 hours in 1950.
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we can note that South Korea, China and Taiwan have recently become more popular among the life sciences industry, while India - still popular - is losing ground to the countries in the north. Maybe the most notable observation is that Japan has entered the main stream of multi-national industry-sponsored clinical trials; five years ago, about 90% of all Japanese trial sites were involved in local registration trials, while today about 50% are involved in multi-national industrysponsored clinical trials. Japan is no longer in
isolation.
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Taipei - Taiwan
Conference Focus
Conference Chair
Johan Karlberg, MD, PhD Visiting Professor Taipei Medical University
Conference Secretariat
aoncheng@hku.hk
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Portuguese
Portuguese is spoken by 240 million persons worldwide in total
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Abstract
The objective of the current study is to depict the globalization of industry-sponsored clinical trials based on the US trial registry five-year set of data, i.e. from January 1, 2006 to December 31, 2010. The analysis will also be made for two consecutive 2.5-year periods with the purpose of observing any changes in the distribution of the number of phase II/III industrysponsored clinical trial sites over continents and countries. Phase III trials had on average around 47 sites per trial and phase II trials about 18 sites per trial; together, phase II and III trials represent 58.3% and 86.0% of all industry-sponsored trials and sites registered, respectively. Over the five years there were 7,603 phase II/III trials registered and initiated with 242,931 study sites. Based on all five years of observation, North America and Europe (Western) contributed 45.6% and 24.6% of all phase II/III study sites, respectively, giving a total of 70.2% for the established regions. However, North America and Europe have jointly lost 1.1% (chi-square test, p<0.05) of the number of study sites over the two 2.5-year period of observation; the percentage has changed from 70.7% (95% confidence interval: 70.43-70.93%) to 69.6% (95% confidence interval: 69.35 to 69.87%). The number of sites have increased in both Asia and East Europe during the two periods of observation by 1.2% (chi-square test, p<0.05) and 0.4% (chi-square test, p<0.05), respectively while the number has decreased in Latin America and Africa by 0.4% (chi-square test, p<0.05). For the period of 2008.07 to 2010.12, East Europe was still the most popular emerging region for industry-sponsored clinical trials with 12.5% of the total number of sites, while Asia now contributes 9.7% of all sites globally. The emerging clinical trial countries can no longer be called emerging countries, owing to the fact the globalization of industrysponsored clinical trials have been taking place since the introduction of the ICH GCP Guideline in 1997. However, a few recent, obvious trends can still be observed between regions and countries, notably an increased focus on North Asia and East Europe, taking the attention from established regions and Latin America. Another trend is that relatively small countries in established regions are still losing positions. In a new moment in time of translational medicine, industry collaboration is a must for translating discoveries into useful medical treatments and procedures and also in fostering the next generation of biomedical scientists. This causative relationship has now been widely accepted both by government bodies and academia, and this will drive the competition between countries to an even higher level.
Summary
The objective of this study is to depict the globalization of industry-sponsored clinical trials based on phase II/III clinical trials registered in the US trial registry between 2006 and 2010. Some obvious globalization trends can be observed between regions and countries, notably an increased focus on North Asia (+1.2% sites) and East Europe (+0.4%), taking the attention from established regions (-1.1%) and Latin America (-0.4%). Another trend is that relatively small countries in established regions such as the Nordic Countries are still losing positions. The decade-long globalization trend, i.e. the shift in industry-sponsored clinical trials to emerging regions is still ongoing now with an increased industry synchronized focus on North Asia. Notably, China has for the first time entered the mainstream of this globalization process, and Japan is no longer isolated to only conducting locally registered trials. Welcome Japan and welcome China!
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English
English is spoken by 900 million persons worldwide in total
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Introduction
There are many important factors to the globalization of industry-sponsored clinical trials, namely knowledge transfer, education, access to promising new treatments, international collaborations, and financial incentives. It is thus crucial to continuously follow this process to be able to answer questions like: How far will this process go? Have we reached a
Methods
All clinical trials registered in www.ClinicalTrials.gov were downloaded on December 31, 2010. Essential information was extracted and coded by a tailor-made SAS program (Statistical Analysis System) developed by the author.3 The dataset was subsequently analyzed using SAS.
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Spanish
Spanish is spoken by 500 million persons worldwide in total
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Results
Phase I-IV trials - over five years
Table 1 provides information about the number of clinical trials and the associated number of study sites for all industry-sponsored phase I-IV clinical trials registered in the US trial registry that were initiated between January 2006 and December 2010, that is trials initiated over five full years. This information has been segregated into two 2.5-year periods: 2006.01 to 2008.06 and 2008.07 to 2010.12. The results are also depicted graphically in Figures 1-2. Differences in the numbers for the two periods can be observed. For example, there was an increase in the number of phase I trials over time from 1,584 to 2,461. Phase II and phase III trials represent 25.0% and 61.0% of all sites, respectively with similar figures for the two periods under observation (Table 1, Figure 2). The analysis will be based on Phase II and III trials since they are legally enforced to be registered in the US trials registry if those trials are under the US FDA oversight. Phase III trials have on average around 47 sites per trial and phase II trials about 18 sites per trial (Figure 2); together, phase II and III trials represent 58.3% and 86.0% of all industry-sponsored trials and sites registered, respectively (Table 1).
number of related study sites for 2006.01 to 2008.06 (Table 3), for 2008.07 to 2010.12 (Table 4) and for 2006.01 to 2010.12 (Table 5) for the leading 60 countries ranked by the total number of sites over the five years of observation. Tables 3-4 include information for both phase II and III trials and give the geographic distribution of the trials; a local trial is defined as a trial that is conducted in one country, and a multi-national trial is defined as a trial conducted in more than one country. Table 5 provides information about the change in the number of study sites over the two 2.5-year periods for each country. The countries with the largest absolute percentage change in the number of study sites between the two 2.5 years of observation are graphically displayed in Figure 5. Tables 3-4 highlight a few recent trends over the two 2.5-year periods of observation; (1) Japans proportion of the number of local industry sponsored trial sites has decreased a fall from 78.9% to 53.3%; (2) several emerging countries such as Russia and Poland have increased their proportion of the number of phase II trial sites based on the total number of phase II/III trial sites from about 23% to 32%; but (3) China, on the other hand, still holds a relatively low proportion of the number of phase II trial sites 8.1% and 10.1%. Table 5 and Figure 5 give details about the change in the percentage of the number of industry-sponsored II/III trial sites over the two 2.5-year periods of observation. Eleven countries had a significant (p<0.05) increase in the percentage, with South Korea and China representing the top two gainers. They are accompanied by another three Asian countries, namely Taiwan, Japan and Thailand. There were fifteen countries that experienced a significant decrease in the percentage of sites (Figure 5), with Argentina and Canada positioned in the lower tale of the distribution.
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Chinese (Mandarin)
Mandarin is spoken by 1,200 million persons worldwide in total
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JUST RELEASED
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Table 1. The number of clinical trials and corresponding number of study sites for all industry-sponsored trials registered in the US trial registry initiated between January 2006 to June 2008 and between July 2008 and December 2010, respectively.
2006.01 to 2008.06 Trials Phase I II III IV n 1,584 1,888 1,867 712 Sites n 5,891 33,714 90,779 15,913
Total
. Sites n 13,357 70,528 172,403 26,326 Trials % 31.0 30.4 27.9 10.7
Total
II+III
6,051
3,755
146,297
124,493
6,987
3,848
136,317
118,438
13,038
7,603
282,614
242,931
100.0
58.3
100.0
86.0
90,779
Figure 1. The number of clinical trials and corresponding number of study sites for all industry-sponsored trials registered in the US trial registry initiated between January 2006 to June 2008 and between July 2008 and December 2010, respectively. Values taken from Table 1.
1,000
50,000
100,000
Trials (n)
Sites (n)
62.1
Figure 2. The number of sites per trial and percentage of all sites for all industry-sponsored trials registered in the US trial registry initiated between January 2006 to June 2008 and between July 2008 and December 2010, respectively by trial phase. Values derived from Table 1.
75.0
25.0
0.0
25.0
50.0
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Table 2. The number of phase II/III trials and number of related study sites for all industry-sponsored trials registered in the US trial registry initiated between January 2006 to June 2008 or between July 2008 and December 2010, respectively by continent. Note that a certain trial can be conducted in more than one continent and is thus counted more than once.
Change in the number of sites Period 1 2006.01 to 2008.06 Trials Continent N America Europe (Western) n 2,260 1,544 Sites n 57,044 30,943 . Sites % 45.8 24.9 Trials n 2,372 1,581 Period 2 2008.07 to 2010.12 Sites n 53,658 28,783 . Sites % 45.3 24.3 Trials n 4,632 3,125 Sites n 110,702 59,734 Total Sites % 45.6 24.6 Sites / trial n 23.9 19.1 . over the two period Percentage Change % Chi-square -0.5 (NS) -0.6 (p<0.05) Relative Change % -1.1 -2.2 .
Total
East Europe Asia Latin America Oceania Middle East Africa
3,804
879 884 563 418 215 310
87,987
15,148 10,586 5,857 2,411 1,062 1,442
70.7
12.2 8.5 4.7 1.9 0.9 1.2
3,953
934 996 579 409 252 232
82,441
14,860 11,466 5,103 2,330 1,058 1,180
69.6
12.5 9.7 4.3 2.0 0.9 1.0
7,757
1,813 1,880 1,142 827 467 542
170,436
30,008 22,052 10,960 4,741 2,120 2,622
70.2
12.4 9.1 4.5 2.0 0.9 1.1
22.0
16.6 11.7 9.6 5.7 4.5 4.8
-1.1 (p<0.05)
0.4 (p<0.05) 1.2 (p<0.05) -0.4 (p<0.05) 0.0 (NS) 0.0 (NS) -0.2 (NS)
-1.5
3.1 13.9 -8.4 1.6 4.7 -14.0
3,269 7,073
36,506 124,493
29.3 100.0
3,402 7,355
35,997 118,438
30.4 100.0
6,671 14,428
72,503 242,939
29.8 100.0
10.9 16.8
3.6 0.0
(*) The changed number of sites over the two periods is based on the percentage change in the number of sites between the two periods multiplied with the actual total number of sites
Year of study initiation and the number of phase II/III trial sites
2006.01 to 2008.06 North America Europe East Europe Asia Latin America Oceania Middle East Africa 2008.07 to 2010.12 North America Europe East Europe Asia Latin America Oceania Middle East Africa 75,000 50,000
57,044 30,943 24.9 45.8
Figure 3. The number of phase II/III study sites for all industry-sponsored trials registered in the US trial registry with the study initiation date between January 2006 to June 2008 and between July 2008 and December 2010, respectively by continent. Values taken from Table 2.
45.3
14,860 11,466 5,103 2,330 1,058 1,180 4.3 2.0 0.9 1.0
12.5 9.7
25,000
0.0 0
Sites (n)
1.5
1.0
0.5
0.4
0.0
for studies with initiation dates between January 2006 to June 2008 and between July 2008 and December 2010, respectively. The results are
-0.5
-1.0
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Table 3. The number of phase II/III trials and the number of related study sites for all industry-sponsored trials registered in the US trial registry with a study initiation date between January 2006 and June 2008 (2.5 years). The leading 60 countries ranked by the total number of sites over five years of observation (2006 to 2010) are included. Local sites are defined as trials only conducted in one country.
2006.01 to 2008.06 Multi-national trials Phase II Trials Rank 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Country US Germany France Canada Japan Spain Italy Russia UK Poland India Australia Belgium Czech Rep. Hungary Brazil Argentina China Netherlands Ukraine South Korea Mexico Romania South Africa Israel Sweden Austria Taiwan Slovakia Bulgaria Denmark Finland Turkey Greece Switzerland Chile Norway Portugal Philippines Peru Colombia Thailand New Zealand Lithuania Malaysia Latvia Estonia Serbia Croatia Hong Kong Ireland Singapore Guatemala Belarus Georgia Indonesia Tunisia Egypt Costa Rica Lebanon n 426 274 199 242 11 193 171 133 211 149 79 123 132 97 86 49 68 12 95 50 55 68 71 71 51 85 74 44 44 53 63 46 31 30 48 42 48 26 22 29 14 26 28 31 14 23 27 22 21 15 16 24 5 2 6 3 5 7 4 5 . n 8,056 1,534 898 1,193 97 726 649 696 693 669 537 475 392 431 424 189 255 52 266 314 175 223 305 314 208 216 170 141 163 225 179 116 90 76 76 113 117 62 59 69 44 52 74 87 33 51 58 55 56 32 25 34 9 2 25 3 5 12 7 6 Phase III Trials n 547 447 355 404 45 344 330 267 323 338 211 255 269 254 225 194 225 96 229 152 173 202 158 180 138 195 198 130 137 100 146 135 106 112 132 117 91 96 77 81 69 68 79 81 63 71 83 65 60 83 61 67 15 21 5 16 15 14 16 8 Sites . . n 22,050 5,048 3,197 3,344 743 2,520 2,340 2,307 2,254 2,267 1,609 1,573 1,272 1,304 1,178 1,433 1,434 854 1,087 1,056 769 951 697 922 778 746 708 488 512 471 525 474 338 401 406 321 338 345 295 255 203 204 221 255 179 179 184 172 166 158 172 112 18 54 7 60 41 29 25 12 Phase II Trials n 667 68 27 35 92 19 27 8 41 2 12 13 16 0 2 4 3 7 9 0 12 5 1 4 9 11 13 9 0 1 10 8 3 1 7 3 2 0 4 0 1 4 3 0 1 1 1 2 0 1 2 1 1 0 1 0 0 2 0 1 Sites Local trials . n 8,597 333 192 173 987 243 87 53 117 7 59 32 19 0 8 14 11 45 13 0 30 22 14 6 25 47 13 32 0 1 14 26 6 6 8 11 5 0 4 0 1 10 5 0 10 2 3 4 0 3 2 1 5 0 4 0 0 3 0 1 Phase III Trials n 484 65 26 18 129 15 16 6 16 7 14 10 3 3 1 27 4 50 6 0 26 4 0 4 3 1 3 5 0 0 9 5 6 0 5 0 2 0 5 2 0 3 0 0 2 0 1 0 0 2 0 1 0 0 0 1 0 0 1 0 Sites . . n 13,465 811 343 166 2,151 158 148 58 111 48 58 31 4 21 10 107 18 245 95 0 93 9 0 22 3 19 31 16 0 0 9 45 53 0 5 0 5 0 17 14 0 5 0 0 21 0 1 0 0 3 0 4 0 0 0 1 0 0 1 0 Phase II Trials n 1,093 342 226 277 103 212 198 141 252 151 91 136 148 97 88 53 71 19 104 50 67 73 72 75 60 96 87 53 44 54 73 54 34 31 55 45 50 26 26 29 15 30 31 31 15 24 28 24 21 16 18 25 6 2 7 3 5 9 4 6 . n 16,653 1,867 1,090 1,366 1,084 969 736 749 810 676 596 507 411 431 432 203 266 97 279 314 205 245 319 320 233 263 183 173 163 226 193 142 96 82 84 124 122 62 63 69 45 62 79 87 43 53 61 59 56 35 27 35 14 2 29 3 5 15 7 7 Sites Sites Multi-national + local trials Phase III Trials n 1,031 512 381 422 174 359 346 273 339 345 225 265 272 257 226 221 229 146 235 152 199 206 158 184 141 196 201 135 137 100 155 140 112 112 137 117 93 96 82 83 69 71 79 81 65 71 84 65 60 85 61 68 15 21 5 17 15 14 17 8 . Sites n 35,515 5,859 3,540 3,510 2,894 2,678 2,488 2,365 2,365 2,315 1,667 1,604 1,276 1,325 1,188 1,540 1,452 1,099 1,182 1,056 862 960 697 944 781 765 739 504 512 471 534 519 391 401 411 321 343 345 312 269 203 209 221 255 200 179 185 172 166 161 172 116 18 54 7 61 41 29 26 12 Trials n 2,124 854 607 699 277 571 544 414 591 496 316 401 420 354 314 274 300 165 339 202 266 279 230 259 201 292 288 188 181 154 228 194 146 143 192 162 143 122 108 112 84 101 110 112 80 95 112 89 81 101 79 93 21 23 12 20 20 23 21 14 Total . . Sites n 52,168 7,726 4,630 4,876 3,978 3,647 3,224 3,114 3,175 2,991 2,263 2,111 1,687 1,756 1,620 1,743 1,718 1,196 1,461 1,370 1,067 1,205 1,016 1,264 1,014 1,028 922 677 675 697 727 661 487 483 495 445 465 407 375 338 248 271 300 342 243 232 246 231 222 196 199 151 32 56 36 64 46 44 33 19 Phase II Sites % 31.9 24.2 23.5 28.0 27.2 26.6 22.8 24.1 25.5 22.6 26.3 24.0 24.4 24.5 26.7 11.6 15.5 8.1 19.1 22.9 19.2 20.3 31.4 25.3 23.0 25.6 19.8 25.6 24.1 32.4 26.5 21.5 19.7 17.0 17.0 27.9 26.2 15.2 16.8 20.4 18.1 22.9 26.3 25.4 17.7 22.8 24.8 25.5 25.2 17.9 13.6 23.2 43.8 3.6 80.6 4.7 10.9 34.1 21.2 36.8 Local Sites % 42.3 14.8 11.6 7.0 78.9 11.0 7.3 3.6 7.2 1.8 5.2 3.0 1.4 1.2 1.1 6.9 1.7 24.2 7.4 0.0 11.5 2.6 1.4 2.2 2.8 6.4 4.8 7.1 0.0 0.1 3.2 10.7 12.1 1.2 2.6 2.5 2.2 0.0 5.6 4.1 0.4 5.5 1.7 0.0 12.8 0.9 1.6 1.7 0.0 3.1 1.0 3.3 15.6 0.0 11.1 1.6 0.0 6.8 3.0 5.3
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Table 4. Number of phase II/III trials and the number of related study sites for all industry-sponsored trials registered in the US trial registry with a study initiation date between July 2008 and December 2010 (2.5 years). The leading 60 countries ranked by the total number of sites over the five years of observation (2006 to 2010) are included. Local sites are defined as trials only conducted in one country.
2008.07 to 2010.12 Multi-national trials Phase II Trials Rank 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Country US Germany France Canada Japan Spain Italy Russia UK Poland India Australia Belgium Czech Rep. Hungary Brazil Argentina China Netherlands Ukraine South Korea Mexico Romania South Africa Israel Sweden Austria Taiwan Slovakia Bulgaria Denmark Finland Turkey Greece Switzerland Chile Norway Portugal Philippines Peru Colombia Thailand New Zealand Lithuania Malaysia Latvia Estonia Serbia Croatia Hong Kong Ireland Singapore Guatemala Belarus Georgia Indonesia Tunisia Egypt Costa Rica Lebanon n 507 344 232 272 53 200 192 133 207 194 66 130 177 115 108 50 61 15 119 62 89 51 95 47 55 90 70 67 51 53 67 51 31 25 44 25 38 22 18 25 27 27 31 23 13 27 25 27 20 35 21 34 8 1 10 2 1 5 2 6 . n 8,243 2,188 1,185 1,217 400 929 835 940 786 998 436 572 531 491 527 209 237 51 269 368 339 197 419 265 207 228 169 194 227 212 153 135 110 73 95 74 104 74 41 74 82 54 70 55 33 86 63 72 61 54 38 46 16 1 42 4 2 8 3 22 Phase III Trials n 582 455 354 398 102 328 305 282 321 313 180 249 250 199 178 149 160 81 205 122 183 206 180 145 143 170 146 146 113 89 144 101 111 110 98 84 71 84 85 83 95 100 70 62 68 61 63 51 49 70 49 55 33 22 8 10 12 14 18 13 Sites . . n 22,850 4,502 3,004 2,758 1,444 2,216 2,093 2,068 1,925 1,859 1,451 1,390 1,065 995 976 919 833 930 971 907 920 1,051 853 724 665 670 488 583 470 432 433 330 469 374 287 298 223 300 338 286 327 310 247 192 234 188 175 155 156 138 114 84 83 68 41 41 53 27 41 36 Phase II Trials n 760 84 24 40 76 9 25 9 38 4 11 10 10 4 4 5 1 9 4 0 16 9 2 5 30 11 5 10 1 0 4 6 3 0 6 2 4 1 3 1 0 2 2 0 0 0 0 0 0 2 0 1 0 0 2 2 0 0 1 0 Sites Local trials . n 8,453 372 188 138 793 84 183 52 110 23 38 38 69 22 8 23 1 108 15 0 70 16 9 23 74 22 9 45 2 0 5 55 10 0 8 2 7 6 3 1 0 2 3 0 0 0 0 0 0 7 0 5 0 0 6 5 0 0 2 0 Phase III Trials n 391 47 21 16 118 6 15 1 11 2 17 3 9 3 2 78 0 62 5 0 35 5 3 1 4 1 5 11 0 0 2 7 6 0 4 0 1 0 4 0 1 1 0 0 1 0 0 0 0 1 0 2 0 0 0 0 1 1 1 1 Sites . . n 9,926 297 251 73 1,314 13 135 1 45 2 125 10 22 11 2 202 0 484 19 0 161 16 3 1 12 7 5 41 0 0 3 38 44 0 5 0 1 0 11 0 16 3 0 0 4 0 0 0 0 1 0 4 0 0 0 0 6 4 1 1 Phase II Trials n 1,267 428 256 312 129 209 217 142 245 198 77 140 187 119 112 55 62 24 123 62 105 60 97 52 85 101 75 77 52 53 71 57 34 25 50 27 42 23 21 26 27 29 33 23 13 27 25 27 20 37 21 35 8 1 12 4 1 5 3 6 . n 16,696 2,560 1,373 1,355 1,193 1,013 1,018 992 896 1,021 474 610 600 513 535 232 238 159 284 368 409 213 428 288 281 250 178 239 229 212 158 190 120 73 103 76 111 80 44 75 82 56 73 55 33 86 63 72 61 61 38 51 16 1 48 9 2 8 5 22 Sites Sites Multi-national + local trials Phase III Trials n 973 502 375 414 220 334 320 283 332 315 197 252 259 202 180 227 160 143 210 122 218 211 183 146 147 171 151 157 113 89 146 108 117 110 102 84 72 84 89 83 96 101 70 62 69 61 63 51 49 71 49 57 33 22 8 10 13 15 19 14 . Sites n 32,776 4,799 3,255 2,831 2,758 2,229 2,228 2,069 1,970 1,861 1,576 1,400 1,087 1,006 978 1,121 833 1,414 990 907 1,081 1,067 856 725 677 677 493 624 470 432 436 368 513 374 292 298 224 300 349 286 343 313 247 192 238 188 175 155 156 139 114 88 83 68 41 41 59 31 42 37 Total Trials n 2,240 930 631 726 349 543 537 425 577 513 274 392 446 321 292 282 222 167 333 184 323 271 280 198 232 272 226 234 165 142 217 165 151 135 152 111 114 107 110 109 123 130 103 85 82 88 88 78 69 108 70 92 41 23 20 14 14 20 22 20 . . Sites n 49,472 7,359 4,628 4,186 3,951 3,242 3,246 3,061 2,866 2,882 2,050 2,010 1,687 1,519 1,513 1,353 1,071 1,573 1,274 1,275 1,490 1,280 1,284 1,013 958 927 671 863 699 644 594 558 633 447 395 374 335 380 393 361 425 369 320 247 271 274 238 227 217 200 152 139 99 69 89 50 61 39 47 59 Phase II Sites % 33.7 34.8 29.7 32.4 30.2 31.2 31.4 32.4 31.3 35.4 23.1 30.3 35.6 33.8 35.4 17.1 22.2 10.1 22.3 28.9 27.4 16.6 33.3 28.4 29.3 27.0 26.5 27.7 32.8 32.9 26.6 34.1 19.0 16.3 26.1 20.3 33.1 21.1 11.2 20.8 19.3 15.2 22.8 22.3 12.2 31.4 26.5 31.7 28.1 30.5 25.0 36.7 16.2 1.4 53.9 18.0 3.3 20.5 10.6 37.3 Local Sites % 37.2 9.1 9.5 5.0 53.3 3.0 9.8 1.7 5.4 0.9 8.0 2.4 5.4 2.2 0.7 16.6 0.1 37.6 2.7 0.0 15.5 2.5 0.9 2.4 9.0 3.1 2.1 10.0 0.3 0.0 1.3 16.7 8.5 0.0 3.3 0.5 2.4 1.6 3.6 0.3 3.8 1.4 0.9 0.0 1.5 0.0 0.0 0.0 0.0 4.0 0.0 6.5 0.0 0.0 6.7 10.0 9.8 10.3 6.4 1.7
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Table 5. Number of phase II/III trials and number of related study sites for all industry-sponsored trials registered in the US trial registry, initiated between January 2006 and December 2010 (5.0 years). The leading 60 countries ranked according to the total number of sites over the five years of observation (2006 to 2010) are included.
2006.01 to 2010.12 Multi-national trials Phase II Trials Rank 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Country US Germany France Canada Japan Spain Italy Russia UK Poland India Australia Belgium Czech Republic Hungary Brazil Argentina China Netherlands Ukraine South Korea Mexico Romania South Africa Israel Sweden Austria Taiwan Slovakia Bulgaria Denmark Finland Turkey Greece Switzerland Chile Norway Portugal Philippines Peru Colombia Thailand New Zealand Lithuania Malaysia Latvia Estonia Serbia Croatia Hong Kong Ireland Singapore Guatemala Belarus Georgia Indonesia Tunisia Egypt Costa Rica Lebanon n 2,360 770 482 589 232 421 415 283 497 349 168 276 335 216 200 108 133 43 227 112 172 133 169 127 145 197 162 130 96 107 144 111 68 56 105 72 92 49 47 55 42 59 64 54 28 51 53 51 41 53 39 60 14 3 19 7 6 14 7 12
. .
Phase III Sites Per trial n 34.1 10.5 9.0 7.6 14.3 7.1 7.1 8.0 6.5 6.3 7.7 5.8 4.5 5.1 5.3 5.9 5.9 8.7 4.9 7.2 4.7 4.9 4.6 5.1 5.1 3.9 3.5 3.9 3.9 4.8 3.2 3.6 3.9 3.5 2.9 3.1 3.4 3.6 3.9 3.3 3.3 3.0 3.1 3.1 3.3 2.8 2.4 2.8 3.0 1.9 2.6 1.6 2.1 2.8 3.7 3.8 3.6 2.1 1.9 2.2 % 41.8 6.2 3.8 3.7 3.3 2.8 2.7 2.5 2.5 2.4 1.8 1.7 1.4 1.3 1.3 1.3 1.1 1.1 1.1 1.1 1.1 1.0 0.9 0.9 0.8 0.8 0.7 0.6 0.6 0.6 0.5 0.5 0.5 0.4 0.4 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.1 0.1 0.1 0.1 0.1 0.0 0.0 0.0 0.0 0.0
2006 to 2008 % 41.9 6.2 3.7 3.9 3.2 2.9 2.6 2.5 2.6 2.4 1.8 1.7 1.4 1.4 1.3 1.4 1.4 1.0 1.2 1.1 0.9 1.0 0.8 1.0 0.8 0.8 0.7 0.5 0.5 0.6 0.6 0.5 0.4 0.4 0.4 0.4 0.4 0.3 0.3 0.3 0.2 0.2 0.2 0.3 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.1 0.0 0.0 0.0 0.1 0.0 0.0 0.0 0.0
2008 to 2010 % 41.8 6.2 3.9 3.5 3.3 2.7 2.7 2.6 2.4 2.4 1.7 1.7 1.4 1.3 1.3 1.1 0.9 1.3 1.1 1.1 1.3 1.1 1.1 0.9 0.8 0.8 0.6 0.7 0.6 0.5 0.5 0.5 0.5 0.4 0.3 0.3 0.3 0.3 0.3 0.3 0.4 0.3 0.3 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.1 0.1 0.1 0.1 0.1 0.0 0.1 0.0 0.0 0.0 Change % -0.13 0.01 0.19 -0.38 0.14 -0.19 0.15 0.08 -0.13 0.03 -0.09 0.00 0.07 -0.13 -0.02 -0.26 -0.48 0.37 -0.10 -0.02 0.40 0.11 0.27 -0.16 -0.01 -0.04 -0.17 0.18 0.05 -0.02 -0.08 -0.06 0.14 -0.01 -0.06 -0.04 -0.09 -0.01 0.03 0.03 0.16 0.09 0.03 -0.07 0.03 0.04 0.00 0.01 0.00 0.01 -0.03 0.00 0.06 0.01 0.05 -0.01 0.01 0.00 0.01 0.03
Phase III Trials n 2,004 1,014 756 836 394 693 666 556 671 660 422 517 531 459 406 448 389 289 445 274 417 417 341 330 288 367 352 292 250 189 301 248 229 222 239 201 165 180 171 166 165 172 149 143 134 132 147 116 109 156 110 125 48 43 13 27 28 29 36 22
Total Trials n 4,364 1,784 1,238 1,425 626 1,114 1,081 839 1,168 1,009 590 793 866 675 606 556 522 332 672 386 589 550 510 457 433 564 514 422 346 296 445 359 297 278 344 273 257 229 218 221 207 231 213 197 162 183 200 167 150 209 149 185 62 46 32 34 34 43 43 34
Sites Per trial n 14.1 5.7 5.1 4.6 9.8 4.7 4.2 6.2 3.4 4.9 6.4 4.0 3.0 4.4 4.8 4.0 3.8 6.0 2.5 6.1 3.6 3.4 4.4 4.8 3.5 2.6 2.2 3.2 4.1 4.1 2.4 3.0 3.2 2.8 1.8 2.8 2.5 2.9 2.3 2.6 3.0 2.0 2.4 2.6 2.7 2.7 2.3 2.6 2.9 1.8 1.7 1.4 2.1 1.0 4.1 1.7 1.2 1.6 1.7 2.4
Sites n 33,349 4,427 2,463 2,721 2,277 1,982 1,754 1,741 1,706 1,697 1,070 1,117 1,011 944 967 435 504 256 563 682 614 458 747 608 514 513 361 412 392 438 351 332 216 155 187 200 233 142 107 144 127 118 152 142 76 139 124 131 117 96 65 86 30 3 77 12 7 23 12 29
Sites n 68,291 10,658 6,795 6,341 5,652 4,907 4,716 4,434 4,335 4,176 3,243 3,004 2,363 2,331 2,166 2,661 2,285 2,513 2,172 1,963 1,943 2,027 1,553 1,669 1,458 1,442 1,232 1,128 982 903 970 887 904 775 703 619 567 645 661 555 546 522 468 447 438 367 360 327 322 300 286 204 101 122 48 102 100 60 68 49
Sites n 101,640 15,085 9,258 9,062 7,929 6,889 6,470 6,175 6,041 5,873 4,313 4,121 3,374 3,275 3,133 3,096 2,789 2,769 2,735 2,645 2,557 2,485 2,300 2,277 1,972 1,955 1,593 1,540 1,374 1,341 1,321 1,219 1,120 930 890 819 800 787 768 699 673 640 620 589 514 506 484 458 439 396 351 290 131 125 125 114 107 83 80 78
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Discussion
The drift is still on!
As reported in CTM during 2008 and 2009, there was a clear drift of industry-sponsored clinical trial sites from established to emerging regions.1-2 This drift is still ongoing (2008.07 to 2010.12); the current percentages for the drift of phase II/III trials is 1.1% from North America and Europe to Asia (+1.2%) and to East Europe (+0.4%). A new drifting pattern has been identified; Latin America has recently lost 0.4% of the global number of study sites. Over the past few years, concerns have been raised by both the US and Europe about the impact of the globalization of industry-sponsored clinical trials.5-7 The concerns are, in principle, of two kinds: (i) the quality of the data collected in emerging regions and (ii) the representativeness of the test results for the target population of the medicinal products tested, i.e. in the US and in Europe, respectively. However, those concerns have seemingly not affected this ongoing globalization process. In the industry, it is still believed that it is a good option to move more and more trials into emerging locations to accelerate the completion of the clinical development test programs in compliance with local and international regulations and guidelines.
both Japan and China were not part of this development, since most of their trials were for local registration purposes only. This observation has apparently changed, and it appears that both Japan and China have now entered the mainstream of multicentre clinical trials testing new medicinal products on a global level. It can be assumed that this development will continue, because both Japan and China are of great interest to the international life sciences industry. By including both countries in the new medicinal products testing program, thus avoiding locally registered trials pharmaceutical sales in the two countries can be initiated much faster than at present. The impact of the economic growth of China must also be noted and accepted: China has just overtaken Japan as the worlds second largest economy and is predicted to overtake US leading position in 2020.
Switzerland Lithuania Denmark India Norway Netherlands US UK Czech Republic South Africa Austria Spain Brazil Canada Argentina -0.60
-0.06 -0.07 -0.08 -0.09 -0.09 -0.10 -0.13 -0.13 -0.13 -0.16 -0.17 -0.19 -0.26 -0.38 -0.48
-0.40
-0.20
0.00
0.20
0.40
0.60
Figure 5. The change in the percentage of industrysponsored phase II/III trial sites registered in the US trial registry with a study initiation date between January 2006 to June 2008 and between July 2008 and December 2010, respectively. The results are presented for countries with the largest absolute and significant (p<0.05) change. Values taken from Table 5.
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Table 6. The number of phase II/III study sites for all industry-sponsored trials registered in the US trial registry, initiated between January 2006 and December 2010 (5.0 years) by country and population size. Countries in red have shown the highest decrease in the relative number of sites from 2006.01-2008.06 and 2008.07-2010.12, while countries in green have shown the largest increase (Table 5). The site density is also given as the annual number of industry-sponsored trial sites per million population.
2006.01-2008.06 Sites Country US Germany Canada France Japan Spain Italy UK Russia Poland India Australia Czech Rep. Brazil Argentina Belgium Hungary Netherlands Ukraine South Africa Mexico China South Korea Sweden Romania Israel Austria Denmark Bulgaria Taiwan Slovakia Finland Switzerland Turkey Greece Norway Chile Portugal Philippines Lithuania Peru New Zealand Thailand Colombia Estonia Malaysia Latvia Serbia Croatia Ireland Hong Kong Singapore Indonesia Belarus Tunisia Egypt Georgia Costa Rica Guatemala Lebanon n 52,168 7,726 4,876 4,630 3,978 3,647 3,224 3,175 3,114 2,991 2,263 2,111 1,756 1,743 1,718 1,687 1,620 1,461 1,370 1,264 1,205 1,196 1,067 1,028 1,016 1,014 922 727 697 677 675 661 495 487 483 465 445 407 375 342 338 300 271 248 246 243 232 231 222 199 196 151 64 56 46 44 36 33 32 19
2008.07-2010.12 Sites n 49,472 7,359 4,186 4,628 3,951 3,242 3,246 2,866 3,061 2,882 2,050 2,010 1,519 1,353 1,071 1,687 1,513 1,274 1,275 1,013 1,280 1,573 1,490 927 1,284 958 671 594 644 863 699 558 395 633 447 335 374 380 393 247 361 320 369 425 238 271 274 227 217 152 200 139 50 69 61 39 89 47 99 59
2006.01-2010.12 Sites / year n 20,328 3,017 1,812 1,852 1,586 1,378 1,294 1,208 1,235 1,175 863 824 655 619 558 675 627 547 529 455 497 554 511 391 460 394 319 264 268 308 275 244 178 224 186 160 164 157 154 118 140 124 128 135 97 103 101 92 88 70 79 58 23 25 21 17 25 16 26 16
Population Million n 311.9 81.8 34.3 65.8 127.4 46.2 60.5 61.8 141.9 38.1 1,193.1 22.5 10.5 190.7 40.1 10.8 10.0 16.6 45.8 50.0 112.3 1,341.9 48.5 9.4 21.5 7.7 8.4 5.6 7.5 23.2 5.4 5.4 7.8 72.6 11.3 4.9 17.2 10.6 94.0 3.2 29.5 4.4 67.1 45.8 1.3 28.3 2.2 9.9 4.6 4.5 7.1 5.1 237.6 9.5 10.4 79.7 4.4 4.6 14.4 4.3
Sites per year and million population n 65.2 36.9 52.8 28.1 12.4 29.9 21.4 19.6 8.7 30.8 0.7 36.6 62.3 3.2 13.9 62.3 62.6 32.9 11.6 9.1 4.4 0.4 10.5 41.5 21.4 51.3 37.9 47.5 35.6 13.3 50.6 45.3 22.9 3.1 16.5 32.4 9.5 14.8 1.6 36.3 4.7 28.2 1.9 2.9 72.2 3.6 45.4 9.3 19.2 15.7 11.2 11.4 0.1 2.6 2.0 0.2 5.6 3.5 1.8 3.7
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Based on the number of industry-sponsored trial sites, the rankings of China, South Korea and Taiwan have improved over the past five years, from 22nd to 14th, 23rd 17th and 30th to 27th, respectively. However, Japan, ranked 5th, and India, ranked 11th, have managed to retain their respective positions. The significance of North Asia is further implied by the fact that 28 of Asias 32 universities listed in the top 200 world universities of Times Higher Education, World University Rankings 2010 are located to North Asia: Japan (n=10), China (n=6), Hong Kong (n=5),
South Korea (n=5) and Taiwan (n=2).9 Over the past 10 years China, including Hong Kong, has significantly increased its academic output in the biomedical research area and has today more Medlinelisted articles than the UK and Japan, second only to the US.10 North Asia contributed about 16% of all Medline publications in 2009, equivalent to approximately half of the figures for North America and Europe (Westerns), respectively: China (6.7%), Japan (5.8%), South Korea (2.1%), Taiwan (1.0%) and Hong Kong (0.4%). South Asia, Oceania, Africa, Middle
Country
US Germany Canada France Japan Spain Italy UK Russia Poland India Australia Czech Rep. Brazil Argentina Belgium Hungary Netherlands Ukraine South Africa Mexico China South Korea Sweden Romania Israel Austria Denmark Bulgaria Taiwan Slovakia Finland Switzerland Turkey Greece Norway Chile Portugal Philippines Lithuania
65.2 52.8 36.9 28.1 29.9 21.4 19.6 12.4 1 2 3 4
4.4 0.4
13.3 22.9
32.4
3.1
36.3
1.6
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40
Figure 6. The ranking of the leading 40 countries according to the number of sites over a five-year observation, from 2006-2010. Information about the site density is also provided, i.e. the annual number of such sites per million population. Values taken from
50
80
70
60
50
40
30
20
10
10
20
30
40
Table 6.
Sites/million population
Ranking 2010.12
Number of countries
11 9 Asia N America/Europe East Europe 6 6 5 6
10
Figure 7. The annual number of industry-sponsored phase II/III trial sites per million population for 11 countries in Asia, 16 countries in East Europe and 21 countries in North America or Europe, respectively based on the US trial registry data for 2006 to 2010. Values taken from Table 6.
4
3 2
0 0 to 15 16 to 30 31 to 45 46 or above
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East, East Europe and Latin America each contributed between 2.3% and 4.0% of all Medline publications in 2009. If one was to see new biotech hubs developed in the world, one would likely assume that a few would appear in North Asia. The objective of a bio-medical cluster is to transfer novel discoveries usually made at academic institutions - by commercialization - into clinical practice. The concept of translational medicine also recently became a strong trend in the US and Europe. For instance, the US National Institutes of Health priority areas of 2009 listed translational medicine second after genomics. During the past few years, there has been new developments in the US with the selection of a national consortium of institutions funded by the NIH translational research aimed at accelerating the transition from scientific discoveries to medical therapies. There are three distinct prerequisites for the development of a successful bio-medical cluster: (a) excellent basic and clinical sciences to breed novel discoveries, (b) venture capital expertise to identify novel discoveries suitable for commercialization, and (c) a strong infrastructure, unique network and a relevant supporting organizational structure to facilitate the discovery-commercialization process. Outside Japan, a rapid breed of the three crucial prerequisites can also be noted in some of the major North Asian cities such as Beijing, Shanghai, Seoul, Hong Kong and Taipei. Those cities and maybe other cities in North Asia are in the position to capture on this opportunity.
Figure 8. The shift in industrysponsored phase II/III trial sites from 2006.01 to 2008.06 and 2008.07 to 2010.12. The green points represent a gain in the number of sites, while the red points a loss in the number of sites. Values taken from Table 5.
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annual revenue of the Korean investigative sites can thus have increased by US$ 47 million, possibly reaching US$ 152 million. There is significant additional revenue associated with industry-sponsored trials globally and annually, corresponding to US$ 23 billion. Some of this revenue will be diverted to the head quarters of the trial sponsor and/or clinical trial services provider, but a significant portion will be invested in the country where the trial is conducted. The international life sciences industry may thus spend another US$ 100 million annually in South Korea on top of the US$ 152 million in study site stipends.
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that additional study sites are continuously added into the US trial registry, especially for ongoing phase III trials. Therefore, at no point in time were all the sites identifiable, especially for trials recently registered and initiated.
3. 4.
Statistical Analysis System, Version 9.1.3. SAS Institute, Cary, North Carolina, US, 2007. U.S. Food and Drug Administration. FDA Modernization Act of 2007. Available online at http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=110_cong_public_la ws&docid=f:publ085.110.
Conclusions
The emerging clinical trial countries can no longer be called emerging countries, owing to the fact the globalization of industry-sponsored clinical trials have been taking place since the introduction of the ICH GCP Guideline in 1997. However, a few recent, obvious trends can still be observed between regions and countries, notably an increased focus on North Asia and East Europe, taking the attention from established regions and Latin America. Another trend is that relatively small countries in established regions are still losing positions. In a new moment in time of translational medicine, industry collaboration is a must for translating discoveries into useful medical treatments and procedures and also in fostering the next generation of biomedical scientists. This causative relationship has now been widely accepted both by government bodies and academia, and this will drive the competition between countries to an even higher level.
5.
European Medicines Agency. EMEA strategy paper: Acceptance of clinical trials conducted in third countries, for evaluation in Marketing Authorization Applications 2008. Available online at http://www.emea.europa.eu/Inspections/doc s/22806708en.pdf.
6.
Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, Schulman KA. Ethical and scientific implications of the globalization of clinical research. N Engl J Med 2009:19;816-23.
7.
Challenges to FDAs Ability to Monitor and Inspect Foreign Clinical Trials. Department of Health and Human Services, Office of Inspector General (Report # OEI-01-0800510), 2010. Available online at http://oig.hhs.gov/oei/reports/oei-01-0800510.pdf.
8.
Karlberg JPE. Development of sponsored clinical trials in Asia. Clinical Trial Magnifier 2008;1:77-93. Available online at http://www.ClinicalTrialMagnifier.com.
Acknowledgements
This study could not have been completed without the implementation of the ICMJE policy and the existence of the www.ClinicalTrials.gov trial register. 9.
References
1. Karlberg JPE. Sponsored clinical trial globalization trends. Clinical Trial Magnifier 2008;1:13-9. Available online at http://www.ClinicalTrialMagnifier.com. 2. Karlberg JPE. Uninterrupted Globalization of Industry Sponsored Clinical Trials. Clinical Trial Magnifier, 2009;2:79-94. Available online at http://www.ClinicalTrialMagnifier.com.
10. Karlberg JPE. Biomedical Publication Trends by Geographic Area. Clinical Trial Magnifier, 2009;2:682-701. Available online at http://www.ClinicalTrialMagnifier.com. 11. Getz KA. Sizing Up the Clinical Research Market. Applied Clinical Trials. Mar 1, 2010. Available online at http://appliedclinicaltrialsonline.findpharma.c om/appliedclinicaltrials/CRO%2FSponsor/Sizin g-Up-the-Clinical-ResearchMarket/ArticleStandard/Article/detail/660749.
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Editorial Board
Clinical Trials Centre
Li Ka Shing Faculty of Medicine The University of Hong Kong Queen Mary Hospital 102 Pokfulam Road Hong Kong Phone: (852) 2255 4664 Fax: (852) 2974 1248 E-mail : ctcentre@hkucc.hku.hk Home page: http://www.hku.hk/ctc/
The Clinical Trial Magnifier is a free monthly electronic journal without any financial support from for-profit organizations. The University of Hong Kong, the Clinical Trials Centre, is at present the sole funding source. There are no plans to introduce a subscription fee or to obtain funding from for-profit organizations. Unconditional donations may be accepted in the future as editorial and administrative support. The Magnifier is intended for educational, research, and reference purposes only. The content of this publication should not be substituted for the advice of a qualified healthcare professional. Materials published in the Clinical Trial Magnifier (Magnifier) are the result of research and/or contribution by independent individuals or organizations. The Magnifier / The University of Hong Kong are not responsible for the accuracy or reliability of any data or conclusions reported in such materials. The Magnifier is provided "as is" without warranty of any kind. In no event will The University of Hong Kong and its employees, officers, members, agents, or licensors be liable for any damage of any kind whether direct, indirect, special, incidental, consequential or otherwise resulting from the use of or inability to use the Magnifier.
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Spain
Dr. Maxim V. BELOTSERKOVSKY, MD, DS Medical Affairs PSI CRO AG St. Petersburg Russia Dr. As'ad E. BHORAT, MBBCH, FCFP(CMSA), DA(CMSA) Soweto Clinical Trials Centre Johannesburg South Africa Dr. Qasim E. BHORAT, MBBCH, PGD Family Med, MSM Soweto Clinical Trials Centre Johannesburg South Africa Dr. Giuseppe BIONDI ZOCCAI, MD Division of Cardiology University of Turin Turin Italy Dr. Jorge G. BORETTO, MD Hand and Upper Extremity Surgery Hospital Italiano de Buenos Aires Ciudad Autnoma de Buenos Aires Argentina Dr. Ney Carter do Carmo BORGES, MD, PhD, FACC, FACP, FAHA, FESC Internal Medicine Synchrophar Clinical Trials - FCM UNICAMP Campinas Brazil Mr. Don BUFORD iiBIG New York USA
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Dr. Gerhard FORTWENGEL, PhD, MPH, MSc Faculty III Media, Information and Design Dr. Paulo Roberto G. DOS SANTOS, MSc University of Applied Sciences and Arts Clinical Advisory Unit Hannover Immunobiological Technology Institute Bio-Manguinhos Germany Rio de Janeiro Brazil Dr. Diana P.M. FREY, MD Rheumatology Department Dr. Vadim DREYZIN, MD, CCFP, FCFP University Hospital of Zurich Anapharm Inc. Zurich Toronto Switzerland Canada Dr. Fernando M. GARCIA, MD, MSc Clinical Research IMSS Mexico
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Mr. Anandprabu NARASHIMMAN, PGDCR, BPharm Clinical Trials Research Intelligence PPTS India Pvt Ltd Coimbatore India
Dr. Lars NELLEMAN, MD International Clinical Research, Asia Pacific H. Lundbeck A/S Singapore Dr. Bernard NG, MD Medical Abbott Laboratories Singapore Mr. Chong Jin NG, LLB Healthcare / Medical Diagnostics GE Healthcare Pte Ltd Singapore Ms. Jennifer L. NIEUWOUDT, BSc Medicine Boehringer Ingelheim South Africa Johannesburg South Africa
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The pharmaceuticals referred herein include drugs, medical devices, healthcare products (health food) and cosmetics, excluding Chinese crude drugs. The two parties agree to conduct exchange and cooperation on the systems and regulations, specifications, inspection technology and other related matters of the non-clinical testing, clinical testing, pre-marketing review, production management and post-marketing management of the pharmaceuticals across the straits.
The two parties agree to set up a cooperation mechanism for the matters relating to pharmaceuticals across the straits: Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP); The notification, disposition and tracking of adverse actions and events; The auditing of fake drugs, drugs of inferior quality and drugs forbidden or drugs that violate regulations; and the exchange of information and investigation of the source of such information. The two parties agree to set up a coordination and disposition mechanism for major pharmaceutical safety events across the straits and take the following measures to deal with such events properly: Emergency consultation and exchange of related information; To take control measures in preventing the situation from spreading; To foster an environment that will allow for convenient on-site understanding of the situation; To verify and disseminate information and notify one another of such information; To analyze the cause of the event(s) and provide timely notification of the results of the investigation and disposition; To procure the responsible manufacturers and persons to deal with disputes properly and provide active assistance for the security of the manufacturers suffering damage and customers rights. The two parties agree to strengthen cooperation and actively improve the coordination of the technology standards and regulations of the two parties based on the generally acknowledged pharmaceuticals safety management standards such as ICH, GHTF, etc, so as to promote the safety and effectiveness of pharmaceuticals. The inspection and approval (examination and registration) of pharmaceuticals and the inspection and cooperation of production management regulations shall be based on the foregoing basis to probe the measures to adopt the results from the other partys implementation. The two parties agree to exchange materials and cooperate on their systems and regulations relating to clinical trials, the management of implementation authority and team, the protection of subjects rights and interests and the approval mechanism of clinical trials planning and trial results, etc. The cooperation in R & D of clinical trials and pharmaceuticals across the straits shall be
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actively strengthened in accordance with Good Clinical Practice (GCP) with the aim of reducing repetitive trials by carefully selecting pilot and special projects.
This issue of the Magnifier reports that China has finally entered the global clinical trial arena, and both China and Taiwan are showing strong recent growth in the number of industry-sponsored trial sites. With the recently established collaboration between China and Taiwan, it looks as though China is officially declaring its aims to enter the global life sciences research and development arena by meeting internal quality assurance requirements through a close collaboration with Taiwan.
Total Management Consulting Ltd. The conclusion of the workshop was that North Asia has increasingly become an important geographic area for the life sciences industry for obvious reasons, such as large patient population, large potential markets, numerous highly ranked academic institutions,
Workshop for Clinical Trial Professionals organized by the Taipei Medical University
This workshop held on February 22, 2011 addressed various aspects of clinical trials. Presentations were made by Dr. Herng-Der Chern (far right), Director, Center of Drug Evaluation, Dr. Johan Karlberg (second from right), Director, Clinical Trials Centre, The University of Hong Kong, Dr. Hung-Yi Chiou (moderator, middle), Dean, College of Public Health and Nutrition, TMU, Dr. Catherine Lee (second from left), Area Head, Clinical Operations-Emerging Market Asia, Pfizer, and Mr. Ray Wang (far left), CEO, Taiwan improving clinical research infrastructure and simplified drug regulations. For instance, South Korea has been able to develop an efficient clinical research infrastructure, and Taiwan has recently simplified the clinical trial approval process time to only two weeks for clinical trials of new medicinal products that are overseen by other recognized drug regulatory bodies. The final conclusion of the workshop was that there is a need for further clinical research infrastructure development to facilitate and accelerate clinical trial initiation and the conduct of industry-sponsored clinical trials in order to stay competitive.
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