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A Mid-Study Change to a New IRT Vendor Seems Risky: Why Would I Do It and What Do I Need to Consider?

IRT Rescue Study

In our recent webinar, “Anatomy of a Successful Study Transition: If I Knew Then What I Know Now,” I talked about how you can successfully navigate through a mid-study transition from one interactive response technology (IRT; aka randomization and trial supply management [RTSM]) vendor to another, why these transitions are sometimes necessary and some of the key lessons learned, not just in executing a transition but also in mitigating the need for such an action.  

These lessons stem from my over 25 years of experience with RTSM; during that time, I’ve been involved in around 30 IRT study transitions – either directly or in an oversight role. Given the risk of switching a system that has important roles in participant randomization, kit assignment, management of blinded status, and managing the supply chain to sites, sponsors only undertake a mid-study system transition when necessary. So, what situations would warrant this level of risk? 

Why Transition to a New IRT Vendor 

We often see IRT transitions because a sponsor wants to change their CRO partner mid-study, usually because of enrollment concerns with the existing IRT system or IRT partner. We’ve also been involved in transitions that occurred because the original IRT system did not have the ability to properly control some aspect of the study, such as flexibility around subject visit schedules or supply chain management. Or the sponsor could adjust the randomization configuration mid-study based on learnings from accumulating data, and the existing IRT system cannot support the new requirements. In the webinar, I present a case study of a rarer occurrence - a wholesale transition from one randomization approach to another, specifically to a minimization-based randomization approach. 

Other reasons for a transition to a new IRT system include concerns about the quality of IRT service delivery or end-user support and the acquisition of the IRT vendor by a CRO that has not been qualified by the sponsor. 

Roles of CROs and Sponsors During a Transition 

To ensure the transition goes as smoothly as possible, there are a few things to consider. First, the sponsor needs to clearly communicate the reason for the transition to all parties and set the expectations with respect to wind-down activities required from the incumbent IRT provider. These expectations should include the transition timeline, so there are as few delays as possible in the execution. Activities delegated to the CRO should be reflected in amended contracts. 

In addition, the sponsor or their chosen CRO partner needs to make appropriate resources available to the incoming IRT provider, so transition planning, IRT design and configuration, and data transfer activities can commence promptly. 

Four Key Steps to a Successful Study Transition 

In addition to the considerations above, there are 4 key steps that I consider to be best practice in effecting an IRT study transition:  

  1. Design, configure and validate the new IRT protocol 
  2. Undertake the data transfer process from the existing system 
  3. Develop a cut-over plan with ALL stakeholders; if possible, perform a dummy-run and reach an agreement about how ongoing support items will be transitioned 
  4. Communicate with the sites 

Lessons Learned 

While a mid-study change in IRT systems can be risky, my experience has taught me that transitions can be successfully conducted – with careful consideration of the process and clear communication between all affected parties. Watch the on-demand webinar to hear about a high-risk case study that we successfully transitioned and how the 4 key steps I mention above contributed to that success.  

 

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