From The Editor | January 31, 2024

The Impact Of Protocol Design On An IRT System


By Dan Schell, Chief Editor, Clinical Leader

Irena and Kelsey_510x340
Kelsey Kern & Irina Grishina of CSL Behring

When you’re in a conference session, it’s always great if you can hear actual anecdotes of how a process or system impacted a company’s operations. That’s exactly what Irina Grishina and Kelsey Kern plan to do at their SCOPE Summit presentation, Case Study: Designing the Right IRT for Direct-to-Patient and Home Treatment Studies.

They both work at CSL Behring where Grishina is a senior project manager, ACTT, eClinical Operations, and Kern is a clinical trial supply study manager. According to Kern, the focus of their presentation is not on the IRT system, “It’s more about the impact of how the protocol is designed for dispensation of treatments to patients when home treatment or direct to patient models are incorporated.”

The two case studies they will discuss will come from different therapeutic areas, and they plan to cover a diverse range of topics, including:

  • dosing schedule
  • visit frequency
  • switching between onsite versus home dosing
  • blinding design
  • shelf life and expiry impact
  • temperature control management
  • home transport
  • the IRT visit schedule and dispensation itself
  • instructions for sites

“We will try to cover every detail that can pop up and impact how you can execute the IMP supply for a study, but we don't go very deep on each topic since we don’t have enough time to do that,” says Grishina. They will discuss both a DTP (direct to patient) trial and one where there’s either a patient taking the drug home or where a home healthcare provider is meeting the drug at the patient's home for administration.

During our conversation, I asked how IRT can reduce waste, and I was shocked by all the different ways they listed, much less some of the examples they gave. Say, for instance, a patient unexpectedly goes on vacation, and all the kits that were shipped to their house sit idle until they return, prompting the need for replacement kits being sent. Grishina and Kern plan to share these types of personal stories of how sometimes, despite your best efforts at planning ahead, things still go wrong. More importantly, it’s the lessons learned from those experiences that will undoubtedly be some of the most valuable takeaways from this SCOPE session.