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Table 3 Additional implications of adaptive design features on resource use

From: Practical guidance for planning resources required to support publicly-funded adaptive clinical trials

Feature of adaptive/innovative design

Considerations for resources

Number of interim analyses

The more interim analyses generally the more additional resources required. Setting up suitable systems or investing in software may reduce this

Additional interim analyses may not always provide additional efficiency of the adaptive design [12]

Adaptive randomisation

Using outcome adaptive randomisation [13] may require more complex randomisation systems than non-adaptive or alternative ADs that drop arms for lack of benefit

Multi-arm multi-stage (MAMS) designs

Some approaches such as group-sequential MAMS [14] may have a more variable sample size than alternatives such as drop-the-losers [15]. The more interim analyses and arms there are, the higher the variability in the sample size

Platform trials

A platform trial [16] may have fixed costs for the underlying infrastructure and an additional cost for each arm added in (the latter of which may be lower compared to a new separate trial)

Dose-ranging trials

Changing which doses are allocated to participants may have associated pharmacy costs and also impact on excess treatment costs

Population enrichment

Changes to eligibility

Changes to randomisation method/approach (e.g. a stratification factor or minimisation factor may be dropped)

Training of site staff to understand implications

Changes to PIS