Table 1.
All trials | CS trials | NCS trials | Ph I trials | Ph II trials | Ph III trials | Ph IV trials | |
---|---|---|---|---|---|---|---|
A AAGR (Period 2001 to 2009) (%) | |||||||
IT | +5.0* | +1.3 | +13.0** | +32.8** | +6.3* | +1.5 | +14.7** |
ES | +2.5* | +3.1 | +0.7 | +2.5 | +7.1* | -1.1 | +5.5 |
NL | -1.9* | -2.0* | -1.9 | +1.1 | -3.8* | -2.8* | -5.7* |
DE | -2.3 | -- | -- | -5.3* | -1.6 | -4.3* | +6.4 |
FR | -3.0* | -2.8* | -3.4* | -4.5* | -0.3 | -0.7 | -7.3** |
UK | -5.3* | -0.4 | -15.2* | -- | -- | -- | -- |
B Means (Prior-Posterior Comparison) (n CTA) | |||||||
IT1 | 587 ⇨ 744* | 433 ⇨ 479 | 153 ⇨ 260* | 9 ⇨ 21* | 206 ⇨ 280* | 311 ⇨ 344 | 47 ⇨ 87* |
ES1 | 576 ⇨ 626 | 446 ⇨ 556 | 130 ⇨ 104 | 90 ⇨ 92 | 142 ⇨ 175 | 278 ⇨ 272 | 67 ⇨ 101 |
NL2 | 697 ⇨ 597* | 405 ⇨ 351 | 292 ⇨ 246 | 139 ⇨ 126 | 161 ⇨ 132 | 203 ⇨ 177 | 73 ⇨ 67 |
DE1 | 1,497 ⇨1,428* | (1,300) ⇨ 1,170 | (197) ⇨ 259 | 462 ⇨ 340* | 340 ⇨ 321 | 437 ⇨ 368* | 65 ⇨ 144* |
FR3 | 1,165 ⇨ 973* | 885 ⇨ 727* | 310 ⇨ 247* | 288 ⇨ 221* | 291 ⇨ 288 | 365 ⇨ 350 | 160 ⇨ 101* |
UK1,4 | 1,248 ⇨ 832** | 656 ⇨ 576** | 592 ⇨ 256** | nd ⇨ (301) | nd ⇨ 353 | nd ⇨ 261 | nd ⇨ 218 |
In the case of Germany, exact distribution patterns for sponsorship could not been established for the period prior May 2004, the reported mean (n = 197) refers exclusively to studies initiated by universities or university hospitals. For the UK, trial phase specific distribution patterns prior to 2004 are unknown.
1: IT, ES, DE, UK: Means of three consecutive years prior to implementation (2001 to 2003) versus means for period posterior to implementation (2005 to 2007)
2: NL: Means of three consecutive years 'prior' (2003 to 2005) versus means for years 'posterior' to implementation (2007 to 2009)
3: FR: Means of three consecutive years 'prior' (2001 to 2003) versus years 'posterior' (2007 to 2009). Transition period for implementation of EUCTD in France: 2004 to 2006
4: UK: Means (All trials, CS trials, NCS trials) do not account for phase I trials ('trials with healthy volunteers')
CS/NCS, Commercial/Non-commercial Sponsor; nd, no data; *, significant, defined as P ≤ 0.05; **, highly significant, defined as P ≤ 0.001