Table 1.
Adaptive Designs∗
| Adaptive Design | Description |
|---|---|
| Dose-finding | After interim analysis, a randomized trial with multiple dosing arms assigns more patients to dose groups of higher interest. |
| Hypothesis | After interim analysis, the study hypothesis is altered (e.g., a pre-specified swap of primary and secondary endpoints). |
| Sequential or group sequential | After interim analysis, adaptations include pre-specified options of changing sample size, modification of existing treatment arms, elimination or addition of treatment arms, changes in endpoints, changes in randomization schedules. |
| Randomization | Randomization is adjusted after interim analysis so that patients enrolled later in the study have a higher probability of assignment to a treatment arm that appeared successful earlier. |
| Seamless phase II/III | Study moves from phase I to phase II without stopping the patient enrollment process. |
| Treatment switching | Investigator is allowed to switch patients to a different treatment arm based on lack of efficacy, disease progression, or safety issues. |
| Biomarker adaptive | Interim analysis of treatment responses of biomarkers allows pre-specified adaptations to trial design |
| Pick-the-winner and drop-the-loser designs | After interim analysis, treatment arms are modified, added, or eliminated. |
| Sample size re-estimation | Interim analysis allow sample size adjustment or re-estimation. |
| Multiple adaptive | Multiple adaptive design characteristics applied in a single study. |