Table 4 Assessments
Adaptive study design category | Adaptive features | Boundaries |
|---|---|---|
Assessments | 1. Safety/tolerability samples and assessments (such as safety laboratory, vital signs, electrocardiograms (ECGs), continuous cardiac monitoring etc.) & | 1. Minimum data requirements for progression between dosing regimens/protocol parts |
2. PK/PD/exploratory/other samples and assessments: | 2. Defined sampling or assessment types/categories for which adaptability is permitted | |
a) Additional or less samples or assessments may be taken | 3. Minimum samples/time-points/assessments to sufficiently cover the full safety/tolerability and PK/PD profile in relation to relevant doses (e.g. single dose, steady state) | |
b) Timing of samples or assessments may be adapted | 4. Maximum | |
-blood (or other) volumes | ||
-number of samples or assessments | ||
-sampling or assessment time-points | ||
Assessments | 3. Prolongation or shortening of the in-house period or out-patient follow-up period | 1. Minimum/maximum in-house stay or out-patient follow-up periods based on: |
-study specific safety & tolerability, PK and/or PD parameters that must be reached prior to discharge from the clinic/study | ||
-evolving safety and tolerability profile of the IMP | ||
-and evolving PK/PD characteristics of the IMP up to the decision making time-point |