Table 2.

Characteristics of the pivotal studies (n = 108)

	Number of pivotal studies (%)
Study phase
Phase III	50 (46.3%)
Phase II-III	9 (8.3%)
Phase II	39 (36.1%)
Phase I	2 (1.9%)
Not reported/Not applicable	8 (7.4%)
Center characteristics
Multicenter	91 (84.3%)
Mono-center	5 (4.6%)
Not reported	12 (11.1%)
International character of the study
Multinational	15 (13.9%)
Mono-national	65 (60.2%)
Not reported	28 (25.9%)
Primary endpoint
At least one hard endpoint	21 (19.4%)