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Table 3 Study participants

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

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