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Table 2 Timing/Scheduling

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

Adaptive study design category

Adaptive features

Boundaries

Overlap

Dosing regimens or discrete parts of umbrella protocols may overlap

1. Minimum data requirements for progression between dosing regimens/protocol parts

2. Reference to study specific toxicity rules

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BMC Medical Research Methodology

ISSN: 1471-2288

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