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Table 5 Adaptations planned at the time of scientific advice (SA) letter versus the adaptations implemented in the protocol after SA. A given trial can include several and possibly different types of adaptive elements

From: Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency

Adaptations Planned at the time of SA opinion letter Implemented Not implemented No adaptations mentioned Not retrieved
Dose selection (phase II/III) 16 6 0 2 8
Sample size reassessment 43 6 4 9 24
Stopping for futility 31 7 2 8 14
Stopping for early efficacy 19 1 2 5 11