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Table 4 Assessments

From: Three steps to writing adaptive study protocols in the early phase clinical development of new medicines

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