Multiple Randomizations in Clinical Trials

This is the first of our on-going FAQ series on IRT services in Clinical Trials. You can listen to the recording or read the text below.

In April 2020, a client asked:
Can your system handle multiple randomizations for a subject at different points during a study? That is, can the subject be randomized to a treatment group at visit 1, randomized again at visit 2, and randomized a third time at visit 3?

The short answer is: Yes.

Veracity Logic’s Re-Randomization Module can handle multiple randomization points for subjects throughout a study.

The details for re-randomization will be defined by the project team at the beginning of system development and will be documented in the User Requirements Specification or URS.

For example, one question that will need to be resolved is whether the subject’s current (and any past) treatment assignments are included among the options at each re-randomization.

What do we mean?

Let’s suppose your study has five treatment groups, A through E.

If the first treatment group assigned to the subject was A, would re-randomization include treatment groups A through E or,

because the subject had already been assigned treatment group A,

would re-randomization be limited only to treatment groups B through E?

The same question applies to each subsequent re-randomization.

Once the requirements have been defined and the system has been configured and customized, if necessary, it is tested to ensure that randomization and re-randomization work correctly before being released for use.

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