With the increasing complexity of today’s clinical development landscape comes greater logistical challenges associated with managing trial supplies and subject randomization. In advance of his presentation at the March 2021 SCOPE Conference, Calyx’s Sylvain Berthelot reviews how proven IRT solutions are overcoming these challenges and meeting the needs of today’s advanced clinical trial designs.
Necessity, the Mother of All Innovation
Over the past two decades, clinical trials have become increasingly complex. In order to find treatment-naive patients, multinational studies are now commonplace and are being conducted in a growing number of countries. While these studies provide important access to patient populations, they put significant pressure on trial sponsors and CROs to ensure their randomization and trial supply management (RTSM) practices are up to the task.
The complexity of protocol design is sometimes dwarfed by the complexity of trial execution, when the unexpected happens. This was all too evident in 2020 when the industry faced the unprecedented need to find alternative ways to dispense medication to patients during COVID-19 stay-at-home mandates. Many sponsors had to find ways to ship trial medication directly to patients in countries where regulations previously did not allow it, and obviously without breaking randomization blinds.
At the same time, in order to increase clinical trial productivity, sponsors are turning to adaptive trial designs to gather more information, involve fewer patients, and improve the ethical treatment of patients. Sponsors are also finding that master protocols can increase efficiency and accelerate development timelines. But these trials are complex to manage and present even more risk than traditional trials. Sponsors turn to their IRT partners to reduce the risks these trial designs present while optimizing how medication is distributed and consumed to keep costs of drug management as low as possible.
“A reliable IRT system promises not only logistical simplification, but also cost savings in the quantity of medication overage required to conduct a trial.”
– Sylvain Berthelot, Calyx
IWR and IVR: Managing Logistics through Reliable IRT
Sponsors and CROs need reliable, centralized solutions that deliver flexibility in order to meet the growing RTSM challenges of today’s clinical trials. These solutions commonly use interactive response technology (IRT) via the web (Interactive web response, or IWR) and telephone (interactive voice response, or IVR) as a simple and ubiquitous interface between the central system and users.
Before considering how a proven IRT system can support complex trial designs, let’s briefly review how these solutions operate in managing logistics to simplify the complex.
The core requirements of an IRT system are to manage randomization, medication assignment, medication stock control, and emergency unblinding. The use of centralized electronic methods to perform randomization adds integrity to the process and enables certain methods to be employed which would traditionally be impossible for sponsors to consider.
Because IRT systems are the source of the medication status, location and dispensing, sponsors now use IRT systems not only to simplify the logistics of controlling medication stock across countries and sites, but also as an enabler to reduce the quantity of medication overage required to conduct a trial.
Reducing Headaches – and Costs
With a proven IRT solution, sponsors expect the risks related to randomization, unblinding, and patient dispensing to be controlled at the core of the system. They also expect the management of logistical challenges and risks of supply chain disruption to be an integral part of the solution.
They turn to IRT vendors to address additional problems, such as reducing drug wastage through randomization code look-ahead, partial prediction, or other advanced IRT settings. Although, applying intelligent settings downstream may not impact the packaging requirements defined upstream. So IRT vendors have become an integral part of the demand planning and forecasting process, leveraging actual IRT data to help actively reduce the cost of drug management during the trial run.
In the next installment to this series we’ll review how a reliable, flexible IRT system can support randomization and trial supply management to drive efficiencies in adaptive clinical trials.