Adaptive study design category | Adaptive features | Boundaries |
---|---|---|
Methods | 1. Methodology (such as food, cardiac safety and other clinical assessments, study specific techniques) may be adjusted | 1. Defined methodologies for which adaptability is permitted |
2. Permitted purpose of adjustments | ||
3. Decision making time-points when adjustments may be made | ||
Analysis | 2. Optional analysis of safety, PK/metabolites/PD/exploratory/other samples/assessments: | 1. Minimum data requirements for progression between dosing regimens/protocol parts |
a) Analysis may be limited to selected parameters, dosing regimens and time-points. | 2. Defined sampling or assessment types/categories for which optional analysis is permitted | |
b) Timing of optional analysis of certain parameters may be flexible | 3. Permitted purpose(s) of optional analyses | |
4. Reporting (how, where and when) of the optional analyses |