Transparency measures and analysed clinical trial samples
| Transparency measure | Samples analysed (from successful NDAs) | ||
| All trials (including those in healthy volunteers) | Trials in patients | Trials subject to FDAAA* | |
| Registered in a public registry by 13 months post FDA approval | X | X | |
| Either trial results or a CSR synopsis provided in a public registry by 13 months post FDA approval | X | X | |
| Published in a journal indexed in PubMed, Google Scholar or EMBASE by 13 months post FDA approval | X | X | |
| Results publicly available in some form (results or CSR synopsis in registry, or journal article) by 13 months post FDA approval | X | X | |
| Compliant with FDAAA—‘trial completion date’ interpretation | X | ||
| Compliant with FDAAA—‘approval date’ interpretation | X | ||
*Trials that FDAAA defines as being covered by its results reporting requirements.
CSR, clinical study report; FDA, Food and Drug Administration; FDAAA, Food and Drug Administration Amendments Act; NDA, new drug application.