One of the key functions of an IRT system is to allocate drugs to participants based on their randomized therapy. This is a zero-tolerance process to ensure study integrity and patient safety.
Image Credit: gibranicon/Shutterstock.com
To succeed in allocation, a strong supply management system is essential. Simply put, the correct medication is administered to the appropriate individual at the appropriate time, every time. Let us dig a little deeper.
As with randomization, if allocation to the study drug is not carried out in accordance with the protocol, the entire study may be called into question.
Given modern trial designs, participants may receive crossover or other complex dosing regimens. These complicate execution and ensure the appropriate drug maxim. Even specialists make the error of not using the correct language when it comes to drug management and IRT systems.
When terms are interchanged and muddled, it results in a lack of understanding. Using imprecise language might create unnecessary problems and lead teams to reach incorrect conclusions. The three most commonly misused terms will be discussed below.
Allocation/assignment
These two terms are reasonably interchangeable. Allocation and assignment refer to the IRT system's selection of a site to administer the dose to the participant. It is based on the study's design and programmed algorithm. At the time of the transaction, it is what is intended, not what has consistently occurred.
Dispensing
In a study when in-clinic dosing, such as IV preparations, is not required, dispensing entails providing the drug to a participant to take home or, in a direct-to-patient scenario, delivering the medication to their home.
This is the point at which allocation/assignment transforms into action. As a result, the term "dispensing" is incorrect for an IRT transaction.
IRT systems do not dispense; study staff do. Using this word communicates a level of confidence that is not possible without a confirmation transaction on the dispensation. In addition, it does not confirm that the person was actively dosed.
Dosing
The final phase in the process is for the individual to be actively dosed with the medicine. Dosing, like dispensing, progresses from the theoretical of what the system has assigned/allocated to a practical act performed by study staff, namely the medication consumed by the participant.
The IRT system cannot be certain whether a participant was dosed unless a confirmatory transaction is included in its architecture. Using incorrect terminology during randomization can confuse the IRT system and increase the risk of clinical trial errors.
Data flow and reconciliation
Understanding the distinctions among these three unique processes/terms helps you better interpret what the data in each system truly implies. It might also help you determine the level of reconciliation required.
For example, an IRT system can serve as the single source of truth to ensure compliance and provide the most accurate data to support supply management. Another option is to perform only allocation/assignment in the IRT and use an EDC system to collect dispensation and dosing data.
There are valid arguments for both. The decision is often based on the sponsor's philosophical and practical approach to managing this data flow. But, whatever you choose, be sure your wording is explicit, and you understand the implications.
Supply management
Allocation/assignment is only effective if the medication is readily available where it is required. Without a thorough grasp of system workflows/inputs, logistics procedures, and use/availability calculations, you will struggle to fulfill the baseline of administering the appropriate medication to the right participant at the right time, every time.
The complexities and subtleties of efficient supply management are so intricate that they cannot be completely addressed here. However, one fact about drug supply management and calculations is that it is never about determining the number of participants; rather, it is about predicting when and where the participants will appear.
About Perceptive 
For over 30 years, Perceptive eClinical has been a pioneer in RTSM, building and supporting thousands of studies of all designs, from all therapeutic areas and across all phases.
With industry-leading experts delivering flexible, right-fit solutions to accelerate your trial and safeguard your data, we’re more than just an RTSM provider, we are your ally, in streamlining clinical trials, improving data accuracy, and enhancing the participant experience. We help make trials more efficient, reduce costs, and accelerate time to market.
Sponsored Content Policy: News-Medical.net publishes articles and related content that may be derived from sources where we have existing commercial relationships, provided such content adds value to the core editorial ethos of News-Medical.net, which is to educate and inform site visitors interested in medical research, science, medical devices and treatments.