Case Study

 

Flexible Drug Dispensation at the Site Level

YPrime’s configurable IRT system provides flexibility that is fundamentally different from what any other system can offer.

When an emerging biopharmaceutical company approached YPrime for an IRT system for early phase oncology studies, they also needed a cost-effective solution as quickly as possible. The client was looking for a full-featured IRT system with enough flexibility to support studies with a high likelihood to involve multiple protocol modifications after the study went live. Some IRT users have referred to this as adaptive trial design, where dosage forms, strengths, and even treatment arms need to be modified throughout the life of the active trial.

The use of pre-existing IRT modules, where possible, saved development time and unnecessary expense. Most modules could be configured without the need for any additional development. Recent enhancements to YPrime’s IRT offering included configuration points that provided flexibility not only on a study level, but on a site level as well. With the sponsor retaining control of overall choices and limitations, three modules allowed sites to determine titration and drug delivery variations, based on individual patient responses:

  • Drug type management allows authorized and trained system users to define new drug types and dosage forms in real time
  • Dose level management allows system users to determine the quantity of each drug type available for dispensing and even create new formulations when necessary
  • Dispensation management provides the ability for system users to set dose level availability at specific visits including the ability to up and down titrate

These pre-validated features offer more than just flexibility to sponsors and sites. If using a traditional IRT system, changes in drug types and dispensation after a study goes live typically involve labor-intensive efforts in the form of weeks of custom coding and testing, causing delays, manual intervention and additional expense.

The existing system now allows the sponsor to generate their own drug types, dose levels, and dispensation schedules for new trials.  This flexibility also introduces the ability for sponsors to create extension phases as a data configuration rather than a new study build.