Adaptive trial recruitment and allocation

Track enrollment and changing assignments

Not every adaptive design changes allocation probabilities. If allocation can change, prespecify how, when and for whom, and retain the probability and rule version for each epoch.

Flow diagram

Steps

Define eligibility and recruitment

Specify enrollment rules and baseline assessments.

Specify initial randomization

Record allocation probabilities, concealment and stratification.

Define permitted allocation changes

Link any changes to the prespecified adaptation plan and version.

Track assignment epochs

Retain the rule, eligible arms and allocation probability used for each epoch.

Preserve allocation auditability

Document operational implementation and prevent access to restricted interim information.