Data derivation
For the EMA, for each approved drug, we saved the scientific discussion,
label, and/or public assessment report listed in the database. Figure 1
shows a schematic overview of our method. To find candidate documents,
we searched for the following terms [5, 7-10]: adaptive
design, group sequential design, seamless design, adaptations to the
sample size, sample size re-estimation, adaptations to the patient
population, enrichment, adaptations to the treatment arm selection,
adaptive dose-ranging, adaptive dose-finding, hypothesis adaptive
design, biomarker adaptive design, adaptive treatment switching design,
multiple adaptive design, umbrella design, basket design, platform
design, adaptations to patient allocation, covariate-adaptive treatment
assignment, adaptations to endpoint selection, adaptive randomization
method, and drop-loser design . Once at least 1 of these terms
occurred in a document, the associated submission package was scanned to
determine whether it included terms listed above. These approvals were
incorporated into the candidate list.