Table 2.
Comparison of Miller et al analysis and our reassessment of controlled trials, by drug
| Drug | Company | Miller et al | Re-assessment | ||||||
| Trials subject to FDAAA | Timely registration (%) | Timely reporting (%) | FDAAA compliance (%) | Trials subject to FDAAA | Timely registration (%) | Timely reporting (%) | FDAAA compliance (%) | ||
| Elelyso | *Protalix | 1 | 100 | 0 | 0 | 1 | 100 | 100 | 100 |
| Stivarga | Bayer | 1 | 100 | 0 | 0 | 1 | 100 | 100 | 100 |
| Perjeta | Genentech/Roche | 2 | 50 | 0 | 0 | 2 | 50 | 0 | 0 |
| Signifor | Novartis | 1 | 100 | 0 | 0 | 1 | 100 | 100 | 100 |
| Erivedge | Genentech/Roche | 2 | 100 | 0 | 0 | 2 | 100 | 100 | 100 |
| Zioptan | †Merck/Santen | ‡6 | 17 | 17 | 17 | 1 | 100 | 100 | 100 |
| Eliquis | BMS | 6 | 83 | 33 | 33 | 6 | 83 | 67 | 50 |
| Aubagio | Sanofi | 7 | 86 | 71 | §57 | 7 | 86 | 100 | 86 |
| Zaltrap | Sanofi | 6 | 100 | 67 | 67 | 6 | 100 | 83 | 83 |
| Inlyta | Pfizer | 2 | 100 | 100 | 100 | 2 | 100 | 100 | 100 |
| Stribild | Gilead | 3 | 100 | 100 | 100 | 3 | 100 | 100 | 100 |
| Xeljanz | Pfizer | 11 | 100 | 100 | 100 | 11 | 100 | 100 | 100 |
| Bosulif | Pfizer | 1 | 100 | 100 | 100 | ¶2 | 100 | 100 | 100 |
| MenHibrix | GSK | 3 | 100 | 100 | 100 | 3 | 100 | 100 | 100 |
| Sirturo | Janssen (J&J) | 1 | 100 | 100 | 100 | 1 | 100 | 100 | 100 |
| Median | 2 | 100 | 67 | **57 | 2 | 100 | 100 | 100 | |
| Mid-50% range | (1–6) | (93–100) | (0–100) | (0–100) | (1–4.5) | (100–100) | (100–100) | (93–100) | |
| Overall % | 85 | 62 | 58 | 94 | 90 | 86 | |||
*Protalix was the sponsor on ClinicalTrials.gov for all trials included in this analysis for Elelyso, and all ClinicalTrials.gov-related disclosure activities were the responsibility of Protalix. Pfizer had no responsibility for trial registration or results reporting for Elelyso.
† Miller et al included five controlled trials in their FDAAA analysis despite having collected no data regarding those trials’ completion dates. In our reassessment of the data we found that those five trials were completed prior to the enactment of FDAAA (27 September 2007) and are therefore out of the scope of the analysis. These trials were all sponsored and conducted by Santen rather than Merck.
‡ The 17%t figures were in the Miller et al paper, which suggests six controlled trials instead of the reported seven. This is also consistent with the raw data.
§ The 57% figure is consistent with the raw data in the Miller et al paper, owing to a trial having results reported on time but not registered on time. The reported figure in Miller et al was 71%.
¶ We coded an additional clinical trial as ‘controlled’ because, although it was terminated prior to the controlled portion of the trial, it was originally designed as a controlled clinical investigation. Miller et al coded this trial as non-controlled ‘interventional’.
** The 57% figure is consistent with the raw data in the Miller et al paper, owing to the FDAAA compliance rate for Aubagio being corrected from 71% to 57%. With this change, the median now becomes 57% instead of 67%.
FDAAA, Food and Drug Administration Amendments Act.