Figure 1. Flowchart of review process
The EMA guidance on adaptive designs was released in 2007 [4]. All
eligible approvals were collected after 2007 and divided into 3 periods:
2008–2012, 2013–2016, and 2017–2020. Figure 2 shows that the number
of approvals containing different adaptive designs increased over time.
Over the past 13 years, the number of approvals related to adaptive
designs revealed a significant increasing trend, with a 16.52 Annual
Percent Change (APC). The number of approvals containing adaptive design
in confirmatory trials also increased significantly, with a 15.54 APC.