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Table 5 Methods and analysis

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

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