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. 2012 Apr 29;13:53. doi: 10.1186/1745-6215-13-53

Table 1.

Sponsorship and trial-phase specific patterns: AAGR (A) and prior-posterior implementation means (B)

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