Craig Mooney, VP, Scientific e-Tech Enabled Services, Calyx
In this dynamic industry with so many moving parts, some consider the use of IRT for randomization and trial supply management (RTSM) to be an easy-to-master technology, even touting that becoming an expert can happen in just one day.
This couldn’t be further from the truth. Minimizing the strategic planning that must go into the design of an effective IRT system, as well as the proper management of its lifecycle demonstrates a lack of understanding about how impactful IRT can be to clinical trial outcomes. There are significant consequences that can arise if a study’s IRT system isn’t implemented with insight, expertise, and precise focus on the protocol’s needs.
Randomization Risks
For example, if randomization is implemented incorrectly, the scientific integrity of the entire study could be called into question. This has been evidenced across numerous studies where a sponsor’s primary objectives or endpoints could not be met due to a failed randomization implementation.
Effective and reliable randomization requires more than loading a list. It involves determining how the list will be implemented, i.e.:
- Should blocks be assigned by a site when the site is activated?
- Should they be assigned dynamically to a site as needed?
- How will mis-randomizations or ‘randomized in error’ be handled?
Allocation of Study Drug and Supply Management Risks
Like randomization, if allocation of study drug is not implemented according to the protocol the entirety of the study could be called into question. It would not be unusual given modern study designs for participants to have a crossover or other complicated dosing options. These add to the complications for implementation and ensuring the right medication maxim.
Allocation/assignment will only work if the medication is available where needed. Without a proper understanding of system workflows/inputs, logistics processes, and use/availability calculations, you will struggle to meet the baseline of the right medication, for the right participant, at the right time, every time.
This is another area best left to experts. The complications and details are so fine that they cannot be covered adequately here. But one truth about drug supply management and calculations is that it is never an understanding of the number of participants, it is always about trying to predict when and where the participants will show up.
How IRT Expertise Surfaces
Calyx’s IRT design and management experts extend their deep experience to you and deliver valuable insights that can make a real difference in ensuring effective RTSM throughout your clinical trial. For example, they can demonstrate to you:
- Why an IRT should be designed for its primary objectives and not as a catch-all or EDC replacement
- The nuances of integration data flow and its impact on system development timelines and process
- What data should and should not be distributed/reconciled and why
- The practical difference and implications between visit dates and cycles in oncology studies
- Why randomization block size and ratio could have an impact on drug supply management algorithms
- All the implications of screen failure, rescreening, rerandomization, and randomization replacement
- Why visit dates and transaction dates are not the same and shouldn’t be treated as such
- Where the hidden opportunities for unblinding are in the drug assignment process
- What the basics of resupply are and why trusting the system matters
- Novel approaches to waste reduction such as medication pooling, fractional calculation, and automated algorithm switching
- Why the accuracy of inventory in open-label studies is a challenge to maintain and the tools to mitigate this problem
Conclusion
An IRT system is a critical part of a clinical trial. The implications for failing to get it right can be impactful not only to study goals but to participants as well. For this reason, it requires experts who have many years of experience across many protocols. It is certainly not the type of experience you can get from an afternoon seminar. Don’t moonlight in IRT, because getting it right is serious business.
