Sponsors and CROs must use AI with care says trial IRT expert

Artificial intelligence (AI) will shape the development of interactive response technologies (IRT), but sponsors and CROs must guard against the potential negative impact such systems can have on clinical trials.

The warning came from Robert Hummel, chief operating officer at drug study-focused software developer Suvoda, who told Clinical Insider that understanding the risks associated with AI is key.

Robert Hummel, chief operating officer, Suvoda

“AI is poised to influence IRT and other eClinical technology, but we must do so with great care. Patient privacy, AI hallucinations, or accidental unblinding are real concerns that any IRT provider must address before embarking on an AI initiative,” he said.

To that end, Suvoda recently launched an AI assistant – called Sofia – designed to help supply mangers make the best use of IRT systems. According to the firm, users can ask the system questions and receive answers appropriate to their user role.

“Sofia can help streamline information retrieval, improve productivity, create visualizations like charts and tables, all while maintaining privacy controls and safeguarding the study blind,” Hummel said.

Trial complexity

Use of IRT systems -also called RTSM (Randomization and Trial Supply Management) technologies – is likely to increase as drug studies become more complex according to Hummel.

“Many trial designs would be impossible to manage manually given today’s randomization designs that require centralized software to implement properly. And, for large, complex trials the costs to run a study manually would far outweigh the costs of setting up an IRT system.

“IRT can also help reduce drug wastage by optimizing supply forecasts and minimizing overages. This not only cuts costs but also ensures that patients receive the right medication at the right time, all while maintaining the study blind,” he said.

Competition

And Suvoda is not the only supply predicting that use of IRT will increase. Earlier this month, IQVIA also forecast an uptick in use of the technology, citing the growing cell and gene therapy sector as a demand driver.

Similarly, last week Perceptive eClinical said trial complexity and competition are fuelling innovation in the development of IRT systems.

Hummel acknowledged the dynamic nature of the market, telling us, “The IRT space is competitive, with many vendors offering a range of solutions and functionality. I think what differentiates a company is when they prioritize powerful technology with user-friendly design and top-notch, 24/7 support.”

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