Biopharma favoring multifunctional IRT and RTSM systems for complex trials

Biopharmaceutical developers are increasingly choosing multifunctional interactive response technology (IRT) and randomization and trial supply management (RTSM) platforms for their trials rather than implementing these technologies as separate solutions, according to US tech firm Medidata.

Sponsors and CROs have been using IRT and RTSM systems to streamline and automate the randomization of trial participants for decades.

However, in recent years, the use of such systems has increased, according to Wayne Walker, senior vice president, data experience, at Medidata, who cited growing clinical trial complexity as the key dynamic.

“Before the advent of IRT/RTSM systems, trials were typically conducted by shipping patient-numbered kits in blocks corresponding to the full course of treatments for a study. If a site failed to meet its randomization targets, or experienced patient dropouts, drug shipped to that was simply wasted,” Walker told Clinical Insider.

“Furthermore, this model was unable to handle the sort of modern complex trial designs that are very common these days. How could a patient move between cohorts, or be subject to dynamic dosing rules, if the treatments needed to be determined in advance?

“Only modern IRT/RTSM systems can easily accommodate trials that need patient replacement, variable dosing, complex trial designs, or even very common scenarios like stratified randomization,” he added.

Multifunctional technology

Supplier minimization has been a focus for biopharmaceutical companies in recent years with the idea being that working with fewer contractors reduces oversight costs.

Similarly, drug firms also want to reduce the number of software systems they use, according to Walker, noting that this demand is driving the development of multifunction platforms.

“The IRT/RTSM space is very competitive, with many different vendors trying to carve a niche for themselves in the market. There has been a trend, however, of sponsors moving away from using many different specialized vendors toward using IRT/RTSM systems that support multiple functional areas within a platform of products and experiences.”

And, looking forward, AI is likely to accelerate the development of multifunctional IRT/RTSM systems Walker said, citing projects focused on study design, audit trail, and shipments for example.

“Medidata is actively developing technology that uses natural language processing to analyze trial protocols and automate RTSM study builds. With this technology, an RTSM system will be able to ingest a trial’s design specification and produce a usable study build without extensive oversight by the study teams, greatly accelerating timelines,” he said.

The firm is also using GenAI to make audit trails more easily accessible, Walker said, who told us, “Searching for specific data within an audit trail is already well-supported in many RTSM systems, but GenAI will allow more freeform queries of audits via natural language.

“Finally, by training machine learning algorithms on historical trial logistics data, an RTSM inventory module can dynamically optimize its supply configurations to reduce the risk of stock-outs while also limiting waste,” he said.

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