Table 3 Study participants
Adaptive study design category | Adaptive features | Boundaries |
|---|---|---|
Sample size | 1. The number of subjects in a dosing regimen/cohort can be decreased or increased. | 1. Minimum data requirements for progression between dosing regimens/protocol parts |
2. Minimum/maximum size of a cohort/dosing regimen | ||
3. IMP/placebo ratio | ||
4. Reference to study specific toxicity rules | ||
Sample size | 2. The number of dosing regimens/cohorts may be decreased or increased | 1. Minimum/maximum number of dosing regimens/cohorts (for each study part of an umbrella study), safety and tolerability permitting |
2. Reference to study specific toxicity rules | ||
Selection criteria | 3. Selection criteria may be adaptable | 1. Defined criteria for which adaptability is permitted |
2. Criteria-specific direction and extent of adaptability |