Table 1.

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.