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What is IRT and How Does it Impact Clinical Trials?

What is Interactive Response Technology (IRT) or Randomization and Trial Supply Management System (RTSM)?

An IRT system is known by many other names such as IVRS, IWRS, IXRS, RTSM but regardless of its name, the system delivers a wide range of features for managing patient enrollment and drug supply activities throughout the clinical trial lifecycle.

What are the benefits of using IRT to Support Patient Enrollment into a Clinical Trial?

Patient Enrollment, Randomization and Blind Protection – Utilizing the IRT to handle the enrollment and/or randomization automates the process and eliminates human error compared with manual methods. The system allows for complex protocol enrollment and randomization design and strictly controls sensitive information such as treatment arm and medication treatment assignments to maintain study blinding.

How are Patients Randomized using IRT?

The IRT will systematically randomize patients by assigning them to a treatment arm. There are several common methodologies which can be used such as central, subject stratified and/or site stratified randomization schemes. At the randomization visit, the IRT will assign the subject the appropriate treatment arm based on the programmed randomization methodology. The IRT will typically also assign the subject the appropriate medication kit which matches the randomized treatment arm.

What if I Choose not to use an IRT for Randomization?

To truly appreciate how efficiently an IRT randomizes patients in a double-blind trial, just look at how it was done prior to the availability of IRT. When an IRT is not utilized, each entry on the patient randomization list is associated with a treatment type and matching kit number. The number is sealed in an envelope bearing a sequence number. A block of envelopes and the associated kits are sent to the investigational site where envelopes are chosen in sequence. The matching kit is then dispensed to the patient. While this method is reasonably efficient on an extremely small scale, it is slow and only works with simple randomization designs. Plus, it is subject to human error. When IRT handles randomization, the process is automated and centralized. It can accommodate complex stratification and randomization design that would not be possible with manual randomization. Randomization happens without human intervention, and therefore reduces human error. And, as with other aspects of study management, the system stores the data for easy tracking.  Automating the randomization and drug assignment process eliminates the need for paper envelopes or cards to be stored at the site where unblinded information could be compromised.

How does the IRT help protect the study blind?

An important function of the IRT is to protect unblinded study data from being disclosed inappropriately. For blinded studies, maintaining the blind is pivotal to the integrity of the trial because it eliminates bias in how patient is treated. Without this protection, the study results can be invalidated. Overall, the IRT acts almost as a force field that shields unblinded information, such as the treatment arm and medication type, from those who should not be privy to it. Access to functions in the system is controlled based on user privileges, so only users who should be privy to unblinded data in the IRT can view it. As with all of the activity recorded through the IRT, this information can be transferred to, or integrated with, another system. Controls are put in place so that unblinded data can only be sent securely to the intended recipient.

What About Emergency Unblinding?

The IRT commonly includes emergency unblinding functionality. This can be setup so that Principal Investigators are able to unblind patients at their sites in case of an emergency. When an emergency code break by the site occurs, the system immediately notifies the study team. Often times, that patient who was unblinded by the site is then automatically discontinued from the study, preventing further drug assignments by the IRT. The IRT can also provide access to the Medical Safety team who can unblind any patient at any site without impacting their ongoing participation in the study.

What are the benefits of using IRT for Supply Management?

Individual kits stored at the depot and site are not labeled for particular patients. Instead, kits are assigned to patients when they arrive for their visit. So, shipments to sites only contain enough product to meet patient demand over a certain period, and resupplies are triggered when inventories hit a designated level. This process maximizes drug availability at the site, since products are only allocated to patients when they come in for visits and minimizes drug wastage. The IRT is able to tailor the supply provided to each site since it knows what patients are at each site, their treatment arms, and the visit schedule.

Developing and maintaining an accurate forecast of product demand over the course of a clinical trial is essential to controlling costs. The IRT provides Supply Chain Managers with real-time updates of what is happening with patient enrollment and product inventory throughout the supply chain. This aids with budget preparation, prevents wastage that comes from stockpiling supplies, avoids the risk of stock-outs, and reduces emergency measures needed to replace expiring drugs.

An IRT can also keep track of product expiry dates and ensure there is sufficient time for the patient to take the medication before it expires. It can also send alerts to study managers if expirations are looming. This notification is particularly important with drugs that must be actively managed because they have short shelf lives. Perhaps most important of all, an IRT gives supply managers a global view of available supplies at main depot, secondary depot and site level. They can therefore adjust their inventory and distribution tactics to meet current trial conditions.

How does IRT Provide Inventory Management?

The IRT has a variety of features to manage the chain of custody of supplies in a trial – from the time supplies are packaged and released at the depot through to medication assignment as well as drug returns and destruction. After supplies are physically packaged and made available in the system, initiation and tracking of movement to another depot or site occurs. As soon as the Sponsor activates a site in the IRT, the system triggers a request to the depot for an initial supply of medication. The depot fills the order and sends the shipment to the site. When an order arrives at the site, staff confirm its receipt in the IRT, and the drugs are made available for assignment to patients. As patients visit the site, they are assigned a medication kit from the site’s inventory. All the while, an algorithm within the system is monitoring the inventory at each site. If the inventory reaches a pre-determined low level, the supply engine will generate a request for the depot to send a resupply. Through this closed loop process, shipments are made to accommodate newly enrolled patients, subsequent visits, and any needed replacement stock.

Another significant benefit of the IRT that is often overlooked, is facilitating the task of drug accountability, returns, and destruction. This process is still often done manually in many studies, which is tedious and time consuming.  By switching the process electronically via the IRT, sites can save time, improve efficiency, and reduce data entry error.

How does IRT help with Patient Tracking and Reporting?

All patient and supply data stored in the IRT database are readily available in the form of reports and data lookups. This enables the clinical and drug management team to have access to real-time data, study metrics, and alerts. This allows ease of review of the study as it progresses and to subsequently make any necessary adjustments to things like the enrollment or site’s inventory settings to meet the specific condition of the trial at any given time.

Final Thought:

Essentially, an IRT increases trial efficiency and improves the quality of available information throughout a trial.

 

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