By Tom Schiavon
“We don’t know what we don’t know.”
The situation described in the quote above can be incredibly frustrating, especially when the unknowns can have serious consequences. During a study startup phase, interactive response technology (IRT) system development can be difficult for clinical teams to navigate successfully, especially when team members have limited experience building or using the technology.
I’ve worked in various roles in the IRT industry — in technical support, data management, and project management on the vendor side, and as a liaison between study teams and vendors on the sponsor side. During that time, I’ve supported awful designs, and I’ve even built a few I’d rather not remember. Each experience taught me more about what goes into building an IRT system that meets protocol requirements and allows a study team to more easily manage the operations of a study.
My goal in this two-part article is to distill some of those lessons for clinical team members to empower them to make better decisions when it comes to this crucial technology. Since treatment assignment, drug supply, and patient safety are all critical elements of IRT design, my hope is that you’ll be able to take this information and develop better and safer systems.
What’s In A Name?
IRT. IxRS. RTSM. It goes by many names, but the technology accomplishes the same basic purposes: subject number assignment, randomization, and IP/medication resupply and tracking. You may hear it referred to by different names, depending on the speaker’s role or experience, so I’ve provided a quick breakdown of each term:
Many times, the name you will hear has more to do with the technology vendor than the technology itself. Some sponsors even call the systems something else of their own creation. Regardless of the name, these technologies have become essential tools for managing many clinical trials, primarily from Phase 2 onward.
A Brief History Of IRT
Before technological solutions geared toward randomization and supplies management, those functions were handled manually. In the 1990s, technology took a step toward automating these functions when IVRS allowed sites to call into a system and randomize patients and receive treatment assignments. The process could be slow, as each option was read to the caller and repeated as a confirmation, but the technology was a major step forward in managing a clinical trial, as the phone system could be available at any time, worldwide.
With the advent of web-based technology, IRT became faster and easier to use. Web programming allowed for easier interfaces, more complex functions, and quicker transactions. However, as research centers around the globe had a range of technological capabilities, IWR systems were developed in conjunction with IVRS, allowing sites to use the modality that most favored their capabilities. The ubiquity of the web has begun to sunset IVRS technology. Many sponsors no longer use voice-based systems or reserve it for limited functions such as unblinding.
Most recently, new technologies have made inroads into the clinical trials space. Several providers have mobile technologies that leverage either mobile-optimized pages or dedicated apps to provide increased mobility of computer systems. Other vendors use NLP (Natural Language Processing) to read protocols and configure system functionality. SaaS (Software as a Service) allows sponsors to configure vendor platforms internally, and Bluetooth technology is providing more granular insight into consignment tracking and temperature excursions. Dashboarding is also possible now, giving sponsors the ability to gain increased insight into study operations.
These new technologies are most helpful for small to midsize pharmaceutical or biotech companies that don’t have the resources to build proprietary reporting or monitoring solutions. Larger companies often have solutions available internally and, by intelligently working with IRT vendors to integrate critical data, can improve their own operational intelligence.
When Do I Need An IRT System?
There could be many answers to this question, but the basic response would be that you need an IRT system any time you need randomization, treatment assignment, or supplies managed on a scale that cannot be handled manually.
One nontraditional area that has begun using IRT systems is Phase 1 trials. The nature of Phase 1 trials, with evolving protocols, dosages, small patient populations, and limited drug needs, often precludes the need for an IRT system. However, some vendors have begun offering a new generation of quickly-deployed software systems that have become technologically savvy enough to handle the needs of early-phase trials.
This new breed of systems enables sponsors to use an IRT system and track patients throughout the study, and if the study drug is supplied through the IRT system, it allows the use of pooled drug supplies for better tracking throughout the life cycle of the drug. This is especially true for systems that offer digital accountability and reconciliation modules.
Part 2 of this two-part article will discuss factors to consider when selecting an IRT vendor, design considerations and strategies, and best practices for using the system throughout the life of the trial.
About The Author:
Tom Schiavon, M.A. is an experienced project manager who enjoys exploring the intersection of theory and practice to innovate or improve processes. He gained an understanding of supplies management while serving as an IRT project manager and manager of technical support and data management teams. He obtained his M.A. in English from Florida Gulf Coast University, where he also graduated summa cum laude as an undergraduate. A humanities wonk by nature, he enjoys contributing to the development of novel medications aimed at easing human suffering.