Hey, I need a break from the dosing regimen…!
Your study has a fairly complex drug titration pattern. In addition to multiple pre-planned titrations, subjects in your clinical trial can go up or down one dose level in the maintenance phase, based on medical assessment. If the subject has an unusual medical event intervene in the 'dose escalation' phase – for example, a hospital stay for an unrelated issue – the subject may either need to be discontinued from the trial or somehow be permitted a ‘drug vacation’ after which the system will permit return to a previous dose/visit level or movement to a new level. How to do this with an IRT?
Other IRT systems may not allow this flexibility. But Veracity Logic’s IRT includes a ‘drug hiatus’ functionality which permits a subject to maintain their regular visit schedule but take a break from drug assignment. At the end of the hiatus period, its length set by protocol or flexibly determined by medical assessment, subjects return to drug assignment, either at the previous dose level or at a new level.
Share this Post