In the 1980s, patient-numbered kit labels were shipped to all sites in (generally) fully blocks corresponding to the full course of treatments for a study. The sheer quantity of supply wasted in this method by non-enrolling sites, sites that didn’t fill up randomization blocks, and patient dropouts, was staggering.
In the 1990s, the first clinical IVR systems (Interactive Voice Response Systems) were developed in order to randomize patients over the phone, and later, to dispense drug and resupply sites as well. For the first time, all patient kits could be interchangeable for any other equivalent kit.
In the early 2000s, with the advent of the internet,
the first parameter-driven, web-based (Interactive Web Response Systems) were born. Now there were two widely used terms, IVRS and IWRS, to describe these systems depending on their modality (phone vs. web).
To add to the complication, if an organization used both IVRS and IWRS, the term IxRS was coined to imply either/or. Having said that, the most widely used term today for these systems is IRT (Interactive Response Technologies). IRT is considered more of an umbrella term that encompasses all modalities (voice, web and even mobile).
Historically, IRT was used primarily for randomization and getting drug to the site. Over the years, it became apparent that supply management was just as critical as randomization and the combined action of them together elevates the function of this system. They are synergistic and need to co-exist. It also helps to bridge the siloes between clinical and supply organizations.
There is a treasure-trove of data housed in RTSM systems that can be used to streamline and accelerate clinical trials – both operationally and to enable supply chain optimization. As trials become more complex, it is more important than ever for clinical and supply to be connected.
Along with the terminology evolution, technology has also evolved in tandem. 4G’s use of modern technologies in clinical trials delivers a fully cloud-based, 100% configurable RTSM using natural language processing.
The RTSM has critical functions including dispensing drug and randomizing patients, with direct patient impact. As clinical trials are becoming more complex, the reliance on these systems to function as intended is growing in importance and is becoming more top of mind to regulators. However, when it comes to the management of these systems there is a wide range of processes utilized by sponsors and no industry standard exists. Many organizations have RTSM standards, but across organizations they are managed very differently.
The traditional system design process is cumbersome and complex. A 200+ page specification document is drafted from the final protocol and clinical study team members must review and sign-off on complex technical information they may not fully understand. After sign-off, the system is built by the vendor and the sponsor reviews the system for the first time during UAT. This process ultimately leads to increased findings in UAT and further edits to the system before the system can go-live.
Study teams no longer must approve 200+ page specification documents they may not fully understand – they approve the actual system. The fully deployable system is delivered before the specs are even signed, and in some cases, in a demo state before seeing the actual spec for the first time. The quality increases with each iteration of the system, and the sponsor as confidence that the system they are approving meets the needs of their trial.
While the vendor is responsible to ensure the system is properly validated to perform to requirements, sponsors need to accept the system for use. This process called UAT, involves having the trial sponsor interact with the system and signing-off that it works as intended - or is fit-for-purpose.
"'How much validation is enough?' is a question that all sponsors struggle with. By focusing on those areas that introduce the highest risk to the study; particularly those that are not sufficiently covered by the vendor – should help sponsors hone in to exactly what they need to do to complete the validation of their RTSM."
How flexible is the RTSM to make changes post go-live? It is important to understand the process for and limitations to change the RTSM so you can assess future impact on your study.
configurable and Flexible
4G’s RTSM Prancer is 100% configurable. Updates and changes are made without disruption to the customer. Configurable systems are designed to adapt to client needs. Flexibility is literally built into the system itself.
Partially configurable systems (even 80-90%) can range between 2-6 weeks to implement a small change. Changes are unavoidable in the pharmaceutical industry. You should have a clear understanding how changes impact your study progress from a systems perspective.
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