This trend is echoed in Phase II, with the UK ranking first in Europe and second globally, with 268 trials initiated in 2018 (Table 1 and Figures 4 & 5).
Although the UK’s ranking for early-phase research remains unchanged, Phase I activity across European countries in 2018 has decreased since 2017. Looking at the UK, Germany and France as examples, the UK initiated 117 Phase I trials in 2017 and 95 in 2018, Germany had 94 trials in 2017 and 68 in 2018, and France had 51 in 2017 and 37 in 2018.
The previous ABPI Clinical Trials Report identified the need for action to improve the late-phase clinical research environment, with the UK ranking behind Germany and Spain in Europe for Phase III clinical trials. This trend has continued in 2018, with the UK ranking third in Europe, again behind Germany and Spain, with 292 Phase III trials initiated in 2018 (Table 1 & Figure 6); an increase from the 269 trials initiated in 2017.
Globally, the USA continues to dominate the clinical research environment, leading across phases (Table 1 and Figures 4 - 6) and disease areas (Figures 7 - 12).
Data from China and Japan allows us to track the ever-growing R&D sector in Asia. Over the last few years, China’s clinical research environment has grown across all clinical trial phases, with 234 Phase I, 190 Phase II and 219 Phase III trials initiated in 2018; a substantial increase in activity compared with 2017 (178 Phase I, 146 Phase II and 155 Phase III) (Table 1 and Figures 4 - 6). In addition to China’s increasing focus on R&D[15], it is also important to note their potential to recruit patients, owing to China having 20% of the world’s population[16], which enables them to recruit large patient cohorts.
This year’s new data from Belgium and Hungary shows that both countries are stronger in later phase clinical research, with 208 and 177 Phase III clinical trials initiated in 2018, respectively. For Phase I and Phase II clinical trials, Belgium initiated 39 Phase I and 125 Phase II trials, with two Phase I and 74 Phase II trials initiated in Hungary. This activity ranks both countries behind many of their European competitors (Table 1 and Figures 4 - 6).
This data demonstrates that between 2017 and 2018, the UK maintained its international competitiveness in early-phase research. However, with only minor improvements seen in later Phase III research, the UK must continue to invest in the clinical research environment, supporting initiatives which boost clinical trial recruitment and grow our global standing across early and late clinical research.
Furthermore, with China moving rapidly towards meeting its goal of becoming a global leader in science and innovation by 2050[17] and European research activity decreasing in 2018 compared with 2017, the European R&D base is at risk of falling behind. The UK must harness its expertise and global partnerships, to leverage further collaborations, investment and access to talent.
Rank | Country | Phase I | Country | Phase II | Country | Phase III |
1 | USA | 526 | USA | 1021 | USA | 626 |
2 | China | 234 |
UK |
268 |
Germany | 315 |
3 |
UK |
95 |
Germany | 249 | Spain | 308 |
4 | Germany | 68 | Spain | 221 |
UK |
292 |
5 | Australia | 66 | France | 200 | France | 290 |
6 | Japan | 66 | Japan | 198 | Canada | 289 |
7 | Spain | 49 | China | 190 | Italy | 264 |
8 | Canada | 43 | Canada | 187 | Poland | 250 |
9 | Belbium | 39 | Italy | 157 | Japan | 242 |
10 | France | 37 | Australia | 152 | China | 219 |
11 | Italy | 10 | Poland | 133 | Australia | 211 |
12 | Poland | 10 | Belgium | 125 | Belgium | 208 |
13 | South Africa | 6 | Hungary | 74 | Hungary | 177 |
14 | Switzerland | 6 | Switzerland | 56 | Brazil | 123 |
15 | Hungary | 2 | Brazil South | 37 | Switzerland | 101 |
16 | Brazil | No data | Africa | 20 | South Africa | 77 |
Figure 4. Number of commercial clinical trials started by country, Phase I (2012-2018)
Figure 4. Number of commercial clinical trials started by country, Phase I (2012-2018)
Figure 5. Number of commercial clinical trials started by country, Phase II (2012-2018)
Figure 5. Number of commercial clinical trials started by country, Phase II (2012-2018)
Figure 6. Number of commercial clinical trials started by country, Phase III (2012-2018)
Figure 6. Number of commercial clinical trials started by country, Phase III (2012-2018)