Interactive response technology (IRT), also referred to as randomization and trial supply management (RTSM), plays a central role in managing the drug supply during a randomized clinical trial. IRT informs the blinded clinical sites which pills to give to which patients, and keeps the supply chain in the loop to ensure the right product is in the right place at the right time within a potentially complex clinical trial.
IRT plays a central role in coordinating the investigational product (IP) while maintaining double blinding at a drug trial site. Its core functionality originated with assigning a protocol to each patient and supporting blinding of the clinics administering the treatment. For a simple trial with two protocols, where half the participants are receiving a placebo and the other half are receiving a consistent dose of the IP, the supply chain implications of the randomization are straightforward. The clinic has bottles of pills; half are labeled A and half are labeled B, and the clinic does not know what the difference is.
Many modern clinical trials, however, are much more complicated than the simple example demonstrated above. For instance:
If the drug is expensive, which it likely is due to the low production volumes of drugs that have not received FDA approval, the sponsor would not want to pay for excess inventory sitting at the clinics.
If the drug is being trialed for patients with a relatively rare condition, this suggests a vast array of clinical sites are needed to support required patient volumes. Consequently, this multiplies the cost of excess inventory and increases the supply chain complexity.
Many clinical trials are global in scale, with trials taking place across different continents to balance participant demographics.
Additional challenges come from drugs that have short shelf lives or stringent storage requirements (e.g. COVID-19 vaccines that need to be maintained at super cold temperatures).
Lastly, many trials leverage a variety of different IP doses with potentially adaptive structures to speed time to market. The protocols for patients can change throughout the life of the trial as results are reported and certain protocols are deemed more effective than others.
As such, the considerations above lead to a complex just-in-time (JIT) supply chain with the IRT managing the demand plan and feeding required information to the clinical supply team.
Modern clinical trials could not be as complicated without the advancement of IRTs to support them. Many IRTs can be configured in a matter of weeks to support highly complex trials. Integrations are available to connect the IRT’s demand plan to manufacturing and supply chain organizations — regardless of the firm running the trial — via the drug sponsor or a third-party provider.
Outlook:
Any supply chain practitioner working within the life sciences sector should have a basic understanding of IRT. This is a critical piece of any clinical trial, especially as pressure grows to bring treatment to market more quickly.
Andy Prinz is managing consultant, and Jack Johnson is principal consultant, at PA Consulting.
