How do IWRS clinical trials work?
An Interactive Web Response System (IWRS) is the technology clinical trial managers use to randomize patients into a trial and to track drug supply. Since maintaining the integrity of a blinded study and sustaining drug supply levels are two of the most important parts of a clinical trial, it’s essential to know how your IWRS works and what to look for when choosing a system.
Before the rise of IWRS, Interactive Voice Response Systems (IVRS) required users to use a phone keypad to enter patient information. Today’s IWRS clinical trials work by entering information in a simple computer interface instead. While these systems are more technologically complex, they’re easier for site coordinators and clinical trial managers to use.
How IWRS Clinical Trials Work
Step 1: Choose an IWRS vendor.
If an IWR system has not yet been chosen, or the site is looking to upgrade, there are a few important details to look for when evaluating a new Interactive Response Technology (IRT). To start, make sure the system can communicate with your other technology, including EDC and ePRO systems. Next, ask about the technology’s latest features to make sure it’s up-to-date with the latest in the industry. For example, many of today’s IRT systems use predictive supply chain management to streamline the ordering of study drugs. They also offer more advanced reporting features that help track of what’s happening in a trial while keeping it blinded.
Step 2: Configure the system.
In the past, setting up an Interactive Response Technology was a long process completed alongside the vendor of choice, as the randomization logic behind every trial had to be manually programmed in by experts. It was also difficult to make changes once the system was set up. Today, many vendors offer more of an “out-of-the-box” solution. Rather than working with an engineer to configure the system, for many trials, staff can simply select or enter information about the trial’s visit schedule, dosing, treatment arms, and other details. Some systems even allow sites to enter the study’s protocol as free text in the system, and then use natural language processing to follow directions and create your system.
Step 3: Registration and randomization.
To start, a site administrator registers a patient into the system, including their demographic information and the timing of their site visit. The system then uses the algorithm built in at setup to give the patient their study drug assignment. The site administrator doesn’t see this process – it all happens behind the scenes, which allows the trial to remain blinded.
Step 4: Drug supply management.
In addition to randomizing patients, an IWRS can also automatically order the study drugs for your trial to manage supply and reduce waste as much as possible. Because sites do not know how many patients are receiving the study drug versus how many are receiving the standard treatment or placebo, they can’t order drugs manually. A modern system can also predict changes in supply needs; for example, recalculating if patients drop out of the trial. Your IWRS can also monitor the study drug’s shipping and arrival, making sure that it’s being kept at the proper temperature during transportation and arrives ready to be administered.
Step 5: Check reports.
An IRT system also offers reporting features that can help sites manage the trial. Ideally, a trial won’t have any issues with the quality of its drug supply, but if it does, it’s easy to access information on which (blinded) patients received which drug if changes need to be made.
When your technology is ready to go and you’re ready to take the next step and start enrolling patients for your next trial, Antidote can help.
